In October 2012, when I heard that Superstorm Sandy was projected to make landfall somewhere in the vicinity of DC and Maryland, I prepared for the worst. I stocked up on non-perishable goods and evacuated to higher ground. (The rest of my family was already coincidentally out of town and harm's way.) I put fresh batteries into two flashlights and installed a flashlight app on my smartphone for good measure. Although I didn't give it much thought at the time, I assumed that hospitals in Sandy's path were taking similar precautions - stocking medical supplies, testing backup generators and so forth. So when a power failure at NYU Langone Medical Center (one of the teaching hospitals for NYU School of Medicine, where I received my medical degree) forced an evacuation of the entire hospital, with heart-stopping scenes of neonatal ICU nurses cradling respirator-dependent newborns down several flights of stairs to safety, I couldn't understand what had happened. How had they not been better prepared? Had NYU administrators been the equivalent of residents of low-lying coastal areas who ignored repeated warnings and defied evacuation orders?
As it turned out, NYU did a lot of things right before the storm. According to an article in ProPublica, after the scare of last year's Hurricane Irene, the hospital moved its emergency generators from street level to the rooftop and thoroughly waterproofed the generators' fuel pumps. Unfortunately, they neglected to relocate or protect the electricity distribution circuits, which remained in the basement and were quickly disabled by the flooding. As in many areas of health care, doing everything "almost right" wasn't good enough.
All people are fallible, and health professionals no less so than others. But medicine is usually less forgiving of simple mistakes. A technically perfect surgery is a disaster because it was performed on the wrong body part. A patient develops a life-threatening infection because a doctor forgot to wash his hands. A child dies three days after being discharged from an emergency room because his parents were not notified of critical lab values that came back hours after they left.
People are fallible, but health systems need not be. Despite the staggering complexity involved in flying passenger jets and constructing skyscrapers, commercial airline accidents are rare and building collapses even rarer. Atul Gawande argued in The Checklist Manifesto that checklists are the best way to make sure that small but critical details of health care are addressed systematically, so that every member of a care team feels empowered to preempt potential disasters. I believe that checklists and decision support tools are applicable not only to surgery or intensive care settings, but to primary care as well.
Fortunately, the emergency evacuation of NYU Langone Medical Center went off smoothly. But today, as the news of Hurricane Harvey's devastating impact on Houston's hospitals and nursing homes is just coming into focus, I hope that the good outcome of NYU's near-miss did not make any hospital or public health system complacent about addressing the little details and vulnerabilities that can make all the difference.
**
An earlier version of this post was publised on Common Sense Family Doctor on December 4, 2012.
Monday, August 28, 2017
Monday, August 21, 2017
Procedures and prevention: the challenges of Choosing Wisely
A 55 year-old woman with chronic low back pain and symptomatic knee osteoarthritis asks her family physician's opinion about lumbar fusion surgery and some arthritis walking shoes she saw advertised on television. She is prescribed long-acting oxycodone and physical therapy for back pain, and her orthopedist recently began a series of hyaluronic acid injections for her knees. She is up-to-date on cervical and breast cancer screening, but also desires screening for ovarian cancer.
The next patient is her husband, a 60 year-old man with stable coronary artery disease. He was recently hospitalized for an episode of chest pain, and although tests did not show a myocardial infarction, a cardiac catheterization found an 80% stenosis in the left anterior descending artery. He already takes a baby aspirin daily, but his cardiologist has advised adding clopidogrel and having a coronary stent placed. Last year, he quit smoking after going through a pack of cigarettes a day for 40 years, and he is interested in screening for lung cancer. Also, since his brother was diagnosed with colorectal cancer at age 50, he has undergone screening colonoscopies at ages 40, 45, 50, and 55. These have all been normal, and he wonders if it is necessary for him to continue having them every 5 years.
Although both of these patients are fictitious, they represent common clinical scenarios in family medicine that contain enormous potential for overdiagnosis and overtreatment. In the August 15 issue of American Family Physician, Drs. Roland Grad and Mark Ebell presented this year's edition of the "Top POEMs Consistent with the Principles of the Choosing Wisely Campaign," which included the following suggested clinical actions:
Every aspect of patient care—every word we say, every test or exam we perform, every treatment or procedure we employ—carries with it the possibility of harm as well as the opportunity for benefit. Although eliminating overuse is often perceived as a way of cutting medical costs, it is really about decreasing wasteful, unnecessary testing and treatment that offer only the potential of harm without the corresponding possibility of benefit. Sometimes, we need to leave our old friends behind.
**
This post first appeared on the AFP Community Blog.
The next patient is her husband, a 60 year-old man with stable coronary artery disease. He was recently hospitalized for an episode of chest pain, and although tests did not show a myocardial infarction, a cardiac catheterization found an 80% stenosis in the left anterior descending artery. He already takes a baby aspirin daily, but his cardiologist has advised adding clopidogrel and having a coronary stent placed. Last year, he quit smoking after going through a pack of cigarettes a day for 40 years, and he is interested in screening for lung cancer. Also, since his brother was diagnosed with colorectal cancer at age 50, he has undergone screening colonoscopies at ages 40, 45, 50, and 55. These have all been normal, and he wonders if it is necessary for him to continue having them every 5 years.
Although both of these patients are fictitious, they represent common clinical scenarios in family medicine that contain enormous potential for overdiagnosis and overtreatment. In the August 15 issue of American Family Physician, Drs. Roland Grad and Mark Ebell presented this year's edition of the "Top POEMs Consistent with the Principles of the Choosing Wisely Campaign," which included the following suggested clinical actions:
- In patients with chronic low back pain, do not recommend lumbar fusion over physical therapy for pain or disability.
- In patients with chronic noncancer pain, try to avoid the use of long-acting opioids because they are associated with a significantly increased risk of premature mortality.
- In patients with knee degenerative joint disease, do not recommend hyaluronic acid injections because they are only minimally better than sham injections in improving pain and function.
- In patients with documented knee OA, do not recommend specifically designed walking shoes because they are no more effective than typical walking shoes at relieving pain and improving function.
- In patients with chronic stable angina and at least 70% stenosis of one coronary artery, do not recommend PCI with optimal medical therapy over optimal medical therapy alone.
- In patients with, or at risk of, coronary artery disease, do not add clopidogrel (Plavix) to aspirin because it does not change the overall risk of death.
- In women at average risk, do not recommend screening for ovarian cancer because they are unlikely to experience any mortality benefit.
- In all patients deciding to screen for lung cancer with low-dose CT, discuss the significant risks of harm (3% mortality from invasive procedures after screening) compared with the large number needed to screen to prevent one death from lung cancer (308; 95% confidence interval, 201 to 787).
- In patients who have one first-degree relative with colorectal cancer, but have not developed the cancer by 55 years of age, advise them that their risk is similar to the risk of colorectal cancer in the general population.
Every aspect of patient care—every word we say, every test or exam we perform, every treatment or procedure we employ—carries with it the possibility of harm as well as the opportunity for benefit. Although eliminating overuse is often perceived as a way of cutting medical costs, it is really about decreasing wasteful, unnecessary testing and treatment that offer only the potential of harm without the corresponding possibility of benefit. Sometimes, we need to leave our old friends behind.
**
This post first appeared on the AFP Community Blog.
Wednesday, August 16, 2017
How about ranking how well hospitals serve their communities?
I'm sure that many fabulously talented, skillful, compassionate physicians work at the Cleveland Clinic. If I lived in Cleveland or a nearby town and suffered from a rare or life-threatening disease, I would strongly consider going to the Clinic for specialty care. Maybe I would even work there. But ranking the Cleveland Clinic the #2 hospital in America, as U.S. News and World Report did last week, is outrageous. (Full disclosure: I once blogged for U.S. News.)
My use of the term "outrageous" has little to do with deficiencies in U.S. News's ranking methodology, whose past versions have been criticized for relying more on subjective reputation rather than objective data on safety and quality, and having no correlation with other ratings such as those on Medicare.gov's Hospital Compare website. As Elisabeth Rosenthal has previously reported, hospital rankings are mostly about hype, and it's questionable how much impact they really have on patient choices when every academic or community hospital can probably find at least one high-ranked specialty or service line to brag about.
No, I think this top-notch ranking is outrageous because it only accounts for the patient care that the hospital and its affiliated practices provide, rather than including the health status of the surrounding community - which is awful. Although the Clinic may provide excellent care to patients who walk or are wheeled through its doors, Dan Diamond's recent article in Politico sharply contrasted the overflowing wealth of the medical institution with the barren, crumbling neighborhoods that surround it:
Yes, the hospital is the pride of Cleveland, and its leaders readily tout reports that the Clinic delivers billions of dollars in value to the state. ... But it’s also a tax-exempt organization that, like many hospitals, fought to preserve its not-for-profit status in the years leading up to the Affordable Care Act. As a result, it doesn’t have to pay tens of millions of dollars in taxes, but it is supposed to fulfill a loosely defined commitment to reinvest in its community. That community is poor, unhealthy and — in the words of one national neighborhood-ranking website — “barely livable.”
Hospitals and health systems can't be expected to shoulder the entire burden of improving a community's economic prospects, and many hospitals were originally located in poor neighborhoods because that's where more sick people live. But according to Diamond, its financial figures indicate that the Cleveland Clinic hasn't been doing nearly enough for the community to offset the tax benefits it receives:
[The Clinic's] hospital system cleared $514 million in profit last year and $2.7 billion the past four years, when accounting for investments and other sources of revenue. And since the ACA coverage expansion took full effect, the Clinic’s been able to spend a lot less to cover uninsured patients; its annual charity care costs fell by $106 million from 2013 to 2015. But its annual community benefit spending only went up $41 million across the same two-year period, raising a $65 million question: Did the Clinic just pocket the difference in savings?
“I think we have more than fulfilled our duties,” [Clinic CEO Toby] Cosgrove said in response, pointing to the system’s total community benefit spending, which was $693 million in 2015. The majority of that spending, however, wasn’t free care or direct investments in community health; about $500 million, or more than 70 percent, represented either Medicaid underpayments — the gap between the Clinic’s official rate, which is usually higher than the rate insurers pay, and what Medicaid pays — or Clinic staffers’ own medical education.
It's not that the Cleveland Clinic is blind to the health crisis occurring outside of its doors. Like all nonprofit hospitals, it is required to perform a community health needs assessment (CHNA) every three years. The 189-page document it issued in 2016 provides a dismal accounting of all of the ways in which its local neighborhoods have worse indicators of health than other counties in Ohio and the vast majority of the nation. When Diamond suggested that the Clinic consider increasing its investments in population health, "where fixing community problems like lead exposure and food deserts are viewed as equally important as treating heart attacks," CEO Cosgrove sounded doubtful about what his hospital could or should do about these problems:
"That’s a good direction to go," he allowed. “But how much can we do in population health? We don’t get paid for this, we’re not trained to do this, and people are increasingly looking to us to deal with these sorts of situations,” Cosgrove added. “I say that society as a whole has to look at these circumstances and they can’t depend on just us.”
Judging from readers' comments posted at the end of the article, Cosgrove is far from alone in thinking that it isn't the place of medical institutions to solve the problems of distressed neighborhoods. Physicians and health executives have long believed that the responsibility of medicine is solely to provide health care, not social services or economic benefits outside of employment. But it's 2017, not 1967. As Susan Heavey reported for the Association of Health Care Journalists, in many parts of the U.S. health professionals have successfully partnered with advocates, local officials, and housing developers to "reinvent neighborhoods with [an] eye on health." If the leaders of the Cleveland Clinic wanted a road map for how to help rebuild the surrounding community, they could review one of 10 recent case studies posted by the Build Healthy Places Network, an organization whose mission "is to catalyze and support collaboration across the health and community development sectors, together working to improve low-income communities and the lives of people living in them."
On a national level, rather than allowing CHNAs to gather dust on a shelf (or the online equivalent), health policymakers could use them to allocate public funding for graduate medical education where it is needed most, rather than where it is currently going. As Dr. Melanie Raffoul, one of my past Policy Fellows, wrote recently in an analysis of Texas CHNAs and regional health partnership plans in the Journal of the American Board of Family Medicine:
Many [CHNAs] mentioned problems such as “low literacy,” “food deserts,” or “high levels of teen pregnancy.” Many of these concerns cannot be meaningfully addressed by hospitals, but they can be tackled through increased access to primary care and mental health services, and residency training sites are one way to provide this to the community. This should increase institutions' thinking about their role in larger community strategies to tackle community issues that affect health. Workforce gaps similarly need to be seen in this context—a community resource meant to resolve community needs. ... Community assessments could help refocus the use of publicly funded physician training as part of a broader hospital-community partnership for resolving health needs.
My use of the term "outrageous" has little to do with deficiencies in U.S. News's ranking methodology, whose past versions have been criticized for relying more on subjective reputation rather than objective data on safety and quality, and having no correlation with other ratings such as those on Medicare.gov's Hospital Compare website. As Elisabeth Rosenthal has previously reported, hospital rankings are mostly about hype, and it's questionable how much impact they really have on patient choices when every academic or community hospital can probably find at least one high-ranked specialty or service line to brag about.
No, I think this top-notch ranking is outrageous because it only accounts for the patient care that the hospital and its affiliated practices provide, rather than including the health status of the surrounding community - which is awful. Although the Clinic may provide excellent care to patients who walk or are wheeled through its doors, Dan Diamond's recent article in Politico sharply contrasted the overflowing wealth of the medical institution with the barren, crumbling neighborhoods that surround it:
Yes, the hospital is the pride of Cleveland, and its leaders readily tout reports that the Clinic delivers billions of dollars in value to the state. ... But it’s also a tax-exempt organization that, like many hospitals, fought to preserve its not-for-profit status in the years leading up to the Affordable Care Act. As a result, it doesn’t have to pay tens of millions of dollars in taxes, but it is supposed to fulfill a loosely defined commitment to reinvest in its community. That community is poor, unhealthy and — in the words of one national neighborhood-ranking website — “barely livable.”
Hospitals and health systems can't be expected to shoulder the entire burden of improving a community's economic prospects, and many hospitals were originally located in poor neighborhoods because that's where more sick people live. But according to Diamond, its financial figures indicate that the Cleveland Clinic hasn't been doing nearly enough for the community to offset the tax benefits it receives:
[The Clinic's] hospital system cleared $514 million in profit last year and $2.7 billion the past four years, when accounting for investments and other sources of revenue. And since the ACA coverage expansion took full effect, the Clinic’s been able to spend a lot less to cover uninsured patients; its annual charity care costs fell by $106 million from 2013 to 2015. But its annual community benefit spending only went up $41 million across the same two-year period, raising a $65 million question: Did the Clinic just pocket the difference in savings?
“I think we have more than fulfilled our duties,” [Clinic CEO Toby] Cosgrove said in response, pointing to the system’s total community benefit spending, which was $693 million in 2015. The majority of that spending, however, wasn’t free care or direct investments in community health; about $500 million, or more than 70 percent, represented either Medicaid underpayments — the gap between the Clinic’s official rate, which is usually higher than the rate insurers pay, and what Medicaid pays — or Clinic staffers’ own medical education.
It's not that the Cleveland Clinic is blind to the health crisis occurring outside of its doors. Like all nonprofit hospitals, it is required to perform a community health needs assessment (CHNA) every three years. The 189-page document it issued in 2016 provides a dismal accounting of all of the ways in which its local neighborhoods have worse indicators of health than other counties in Ohio and the vast majority of the nation. When Diamond suggested that the Clinic consider increasing its investments in population health, "where fixing community problems like lead exposure and food deserts are viewed as equally important as treating heart attacks," CEO Cosgrove sounded doubtful about what his hospital could or should do about these problems:
"That’s a good direction to go," he allowed. “But how much can we do in population health? We don’t get paid for this, we’re not trained to do this, and people are increasingly looking to us to deal with these sorts of situations,” Cosgrove added. “I say that society as a whole has to look at these circumstances and they can’t depend on just us.”
Judging from readers' comments posted at the end of the article, Cosgrove is far from alone in thinking that it isn't the place of medical institutions to solve the problems of distressed neighborhoods. Physicians and health executives have long believed that the responsibility of medicine is solely to provide health care, not social services or economic benefits outside of employment. But it's 2017, not 1967. As Susan Heavey reported for the Association of Health Care Journalists, in many parts of the U.S. health professionals have successfully partnered with advocates, local officials, and housing developers to "reinvent neighborhoods with [an] eye on health." If the leaders of the Cleveland Clinic wanted a road map for how to help rebuild the surrounding community, they could review one of 10 recent case studies posted by the Build Healthy Places Network, an organization whose mission "is to catalyze and support collaboration across the health and community development sectors, together working to improve low-income communities and the lives of people living in them."
On a national level, rather than allowing CHNAs to gather dust on a shelf (or the online equivalent), health policymakers could use them to allocate public funding for graduate medical education where it is needed most, rather than where it is currently going. As Dr. Melanie Raffoul, one of my past Policy Fellows, wrote recently in an analysis of Texas CHNAs and regional health partnership plans in the Journal of the American Board of Family Medicine:
Many [CHNAs] mentioned problems such as “low literacy,” “food deserts,” or “high levels of teen pregnancy.” Many of these concerns cannot be meaningfully addressed by hospitals, but they can be tackled through increased access to primary care and mental health services, and residency training sites are one way to provide this to the community. This should increase institutions' thinking about their role in larger community strategies to tackle community issues that affect health. Workforce gaps similarly need to be seen in this context—a community resource meant to resolve community needs. ... Community assessments could help refocus the use of publicly funded physician training as part of a broader hospital-community partnership for resolving health needs.
I began by stating that I didn't think that the Cleveland Clinic deserved to be ranked the #2 hospital in the nation, but since U.S. News and World Report already put it on that pedestal, the Clinic should live up to it by not only providing the best health care for their patients, but getting serious about improving the health of their community.
Thursday, August 10, 2017
On liberty and health reform in America
Since 2007, I've participated in more than a dozen American Civil War battlefield tours sponsored by the Smithsonian Associates. Even though a handful of Chinese Americans fought on both sides of the Civil War, none of my ancestors did, and friends and family are often perplexed by my endless fascination with this conflict. In Civil War museums and sites thronged by overwhelmingly white tourists, I'm even more of an oddity than the rare African American. This realization got me wondering why so few African Americans are passionate about the history of the war that freed so many of their ancestors from slavery. To Atlantic columnist and fellow Civil War buff Ta-Nehisi Coates, this antipathy stems from the efforts of white Americans over the past 150 years to write them out of the story:
For my community, the message has long been clear: the Civil War is a story for white people—acted out by white people, on white people’s terms—in which blacks feature strictly as stock characters and props. We are invited to listen, but never to truly join the narrative, for to speak as the slave would, to say that we are as happy for the Civil War as most Americans are for the Revolutionary War, is to rupture the narrative. Having been tendered such a conditional invitation, we have elected—as most sane people would—to decline.
As reflected in the Presidential election of 2016, economic and racial divisions are always resurfacing, with the perennial Republican versus Democratic contest being portrayed in the media as a battle between the "rich" and the "poor," or white citizens versus those of every other color. But these stereotypes ignore the inconvenient facts that plenty of low-income rural whites who bear no racial grudges and a few minority voters in heavily Democratic states and the District of Columbia dependably vote Republican.
In his most recent book, subtitled "Why the Civil War Still Matters," historian James McPherson shed some light on this present-day paradox by explaining that liberty meant two different things to Southern and Northern leaders in 1861. To white Democrats in the pre-Civil War South (slaveholders or not - and the vast majority were not), liberty meant "freedom from" interference by a distant federal government. Historical figures such as Confederate general Robert E. Lee traced their cause back to the Virginian Founding Fathers and slaveholders George Washington and Thomas Jefferson, whose Revolutionary War was fought to break away from a distant British ruler whose arbitrary actions offended colonial sensibilities.
On the other hand, the Republican Party in the North viewed liberty as "freedom to," arguing that it's hard to achieve anything noteworthy when one is penniless, starving, or a slave. Even though the North won the Civil War, achieving full citizenship for African Americans took nearly a century after passage of the the Fifteenth Amendment to the U.S. Constitution. Only after the hard-won passage of the 1965 Voting Rights Act, which prohibited poll taxes and gave the federal government the power to end various discriminatory practices that prevented most Black citizens in Southern states from registering to vote, did African Americans finally gain freedom to participate in the political process.
The more recent history of how and why African Americans turned away from the party of Lincoln to embrace the party of their former oppressors is too long to recount here, but these differing views of personal liberty - "freedom from" versus "freedom to" - go a long way toward explaining the two political parties' diametrically opposed views of the Affordable Care Act. For the most part, Republican governors have resisted health insurance exchanges and rejected Medicaid expansions because they and their constituents have perceived these provisions of the law as encroachments on freedom by the Washington bureaucracy, while Democratic governors have recognized that it's hard to have freedom to achieve personal success if one is too ill, or too worried about the financial implications of unexpected illness or injury, to plan confidently for the future.
Not only can you find the roots of modern medicine in the American Civil War, but the roots of our current national health policy debate, too.
**
This post first appeared on Common Sense Family Doctor on October 2, 2015.
For my community, the message has long been clear: the Civil War is a story for white people—acted out by white people, on white people’s terms—in which blacks feature strictly as stock characters and props. We are invited to listen, but never to truly join the narrative, for to speak as the slave would, to say that we are as happy for the Civil War as most Americans are for the Revolutionary War, is to rupture the narrative. Having been tendered such a conditional invitation, we have elected—as most sane people would—to decline.
As reflected in the Presidential election of 2016, economic and racial divisions are always resurfacing, with the perennial Republican versus Democratic contest being portrayed in the media as a battle between the "rich" and the "poor," or white citizens versus those of every other color. But these stereotypes ignore the inconvenient facts that plenty of low-income rural whites who bear no racial grudges and a few minority voters in heavily Democratic states and the District of Columbia dependably vote Republican.
In his most recent book, subtitled "Why the Civil War Still Matters," historian James McPherson shed some light on this present-day paradox by explaining that liberty meant two different things to Southern and Northern leaders in 1861. To white Democrats in the pre-Civil War South (slaveholders or not - and the vast majority were not), liberty meant "freedom from" interference by a distant federal government. Historical figures such as Confederate general Robert E. Lee traced their cause back to the Virginian Founding Fathers and slaveholders George Washington and Thomas Jefferson, whose Revolutionary War was fought to break away from a distant British ruler whose arbitrary actions offended colonial sensibilities.
On the other hand, the Republican Party in the North viewed liberty as "freedom to," arguing that it's hard to achieve anything noteworthy when one is penniless, starving, or a slave. Even though the North won the Civil War, achieving full citizenship for African Americans took nearly a century after passage of the the Fifteenth Amendment to the U.S. Constitution. Only after the hard-won passage of the 1965 Voting Rights Act, which prohibited poll taxes and gave the federal government the power to end various discriminatory practices that prevented most Black citizens in Southern states from registering to vote, did African Americans finally gain freedom to participate in the political process.
The more recent history of how and why African Americans turned away from the party of Lincoln to embrace the party of their former oppressors is too long to recount here, but these differing views of personal liberty - "freedom from" versus "freedom to" - go a long way toward explaining the two political parties' diametrically opposed views of the Affordable Care Act. For the most part, Republican governors have resisted health insurance exchanges and rejected Medicaid expansions because they and their constituents have perceived these provisions of the law as encroachments on freedom by the Washington bureaucracy, while Democratic governors have recognized that it's hard to have freedom to achieve personal success if one is too ill, or too worried about the financial implications of unexpected illness or injury, to plan confidently for the future.
Not only can you find the roots of modern medicine in the American Civil War, but the roots of our current national health policy debate, too.
**
This post first appeared on Common Sense Family Doctor on October 2, 2015.
Tuesday, August 1, 2017
Pushing back against prescription drug price gouging
Sometimes missed in the headlines about the stratospheric costs of new specialty drugs is the contribution of price hikes for older, established drugs, including generics, to prescription spending increases. In an editorial in the July 1 issue of American Family Physician, Dr. Allen Shaughnessy described several situations that drug manufacturers exploit to raise prices excessively (also known as price gouging):
- Limited to no alternatives
- Older products with few producers
- Same product, different use
- Single producer, no generic available
- Evergreening (minor changes to gain patent exclusivity)
- Pay for delay (paying generics manufacturers not to sell a generic version of an off-patent drug)
In the United States, Dr. Shaughnessy observed, "The biggest driver of the cost hike is, simply put, that pharmaceutical companies can charge whatever they want. Drugs cost what the market will bear. Many medications could be a lot less expensive, but because an insurance company, the government, or a patient is willing to pay the asking price, there is no push to lower the costs."
Price gouging has become such a problem for patients and insurers that the Maryland General Assembly recently passed legislation to discourage price gouging on essential off-patent or generic drugs. As explained by Drs. Jeremy Greene and William Padula in the New England Journal of Medicine:
The law authorizes Maryland’s attorney general to prosecute firms that engage in price increases in noncompetitive off-patent–drug markets that are dramatic enough to “shock the conscience” of any reasonable consumer. ... To establish that a manufacturer or distributor engaged in price gouging, the attorney general will need to show that the price increases are not only unjustified but also legally unconscionable. ... A relationship between buyer and seller is deemed unconscionable if it is based on terms so egregiously unjust and so clearly tilted toward the party with superior bargaining power that no reasonable person would freely agree to them. This standard includes cases in which the seller vastly inflates the price of goods.
- Limited to no alternatives
- Older products with few producers
- Same product, different use
- Single producer, no generic available
- Evergreening (minor changes to gain patent exclusivity)
- Pay for delay (paying generics manufacturers not to sell a generic version of an off-patent drug)
In the United States, Dr. Shaughnessy observed, "The biggest driver of the cost hike is, simply put, that pharmaceutical companies can charge whatever they want. Drugs cost what the market will bear. Many medications could be a lot less expensive, but because an insurance company, the government, or a patient is willing to pay the asking price, there is no push to lower the costs."
Price gouging has become such a problem for patients and insurers that the Maryland General Assembly recently passed legislation to discourage price gouging on essential off-patent or generic drugs. As explained by Drs. Jeremy Greene and William Padula in the New England Journal of Medicine:
The law authorizes Maryland’s attorney general to prosecute firms that engage in price increases in noncompetitive off-patent–drug markets that are dramatic enough to “shock the conscience” of any reasonable consumer. ... To establish that a manufacturer or distributor engaged in price gouging, the attorney general will need to show that the price increases are not only unjustified but also legally unconscionable. ... A relationship between buyer and seller is deemed unconscionable if it is based on terms so egregiously unjust and so clearly tilted toward the party with superior bargaining power that no reasonable person would freely agree to them. This standard includes cases in which the seller vastly inflates the price of goods.
The scope of the Maryland law is limited. It restricts action to off-patent drugs that are being produced by three or fewer manufacturers, and requires that manufacturers be given an opportunity to justify a price increase before legal proceedings are initiated. It is too early to know if the law will be effective against price gouging, or if it will be copied by other states that are also struggling to contain prescription drug cost increases in their Medicaid programs.
In the meantime, what can family physicians do to help patients lower their medication costs? In a 2016 editorial on the why and how of high-value prescribing, Dr. Steven Brown recommended five sound strategies: be a healthy skeptic, and be cautious when prescribing new drugs; apply STEPS and know drug prices; use generic medications and compare value; restrict access to pharmaceutical representatives and office samples; and prescribe conservatively.
**
This post first appeared on the AFP Community Blog.
In the meantime, what can family physicians do to help patients lower their medication costs? In a 2016 editorial on the why and how of high-value prescribing, Dr. Steven Brown recommended five sound strategies: be a healthy skeptic, and be cautious when prescribing new drugs; apply STEPS and know drug prices; use generic medications and compare value; restrict access to pharmaceutical representatives and office samples; and prescribe conservatively.
**
This post first appeared on the AFP Community Blog.
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