Dan Ho and Becky Elias have a wonderful article in the Boston Review about their new research on the benefits of peer review in restaurant inspections.
Beginning in 2014, we designed a randomized, controlled trial to test the effectiveness of peer review with the food safety staff of King County, where Seattle is located. Half of the inspection staff was randomly assigned to engage in peer review. For sixteen weeks, these inspectors spent one day per week with a randomly selected fellow inspector, taking turns conducting inspections and independently scoring health code violations. We then used information from these peer inspections to identify and train for violations that cause the most confusion.
The results were remarkable. We discovered that, when observing identical conditions in restaurants, health inspectors disagreed nearly 60 percent of the time. Inspectors differed in their assessments of risk magnitude and in interpretations and applications of the health code to particular circumstances, resulting in varying citations for the same condition. Food science is evolving, and the FDA model food code spans nearly 800 pages, so it may not be surprising that implementation varies so much. As one inspector put it, “In the beginning, we [thought] we kn[e]w the code,” but comparing assessments with others provided a “wake-up call.”
A bona fide randomized controlled trial of a government program in a real-world setting? This is rare and exciting stuff, with enormous resonance for public administration and administrative law. (The full research paper will soon be published at the Stanford Law Review.)
It’s also relevant to medicine. If peer review works for restaurant inspections, might it also work for health care? As with restaurants, similar patients are often treated differently depending on who treats them and the norms that prevail in the community. Practice guidelines can moderate that variation, much like the FDA model food code. But guidelines can’t tell you how to deal with atypical cases and they aren’t always followed anyhow. Stitching peer review into medical practice might promote consistency while honoring the clinician’s imperative to attend to the idiosyncrasies of particular patients.
To some extent, peer review has always been a part of medicine—think here of M&M conferences. And it’s starting to get more attention. As Ho and Elias note, Atul Gawande wrote an important New Yorker article in 2011 about surgical coaching. Here at the University of Michigan, Justin Dimick has landed an NIH grant to investigate surgical coaching more generally.
The Ho and Elias study makes me cautiously optimistic about efforts like these. Peer review might or might not work as well for hospitals as it does for restaurants. But it’s certainly worth exploring.
Aaron and his wife both work. When one of their kids wakes up complaining of a sore throat, they begin a ritual staredown to determine which of them is going to have to wait for the doctor’s office to open, call them, wait on hold, schedule an appointment (which will inevitably be in the middle of the day), take off work, pick the kid up from school, wait in the waiting room (surrounded by other sick kids), get seen, get the rapid strep test, find out if the kid is infected, and then take them to the pharmacy or back to school, before returning to work.
Or, one of them could just take the kid to a retail clinic on the way to work/school and be done in 30 minutes.
The undeniable convenience and reliability of retail clinics is the topic of this week’s Healthcare Triage:
The following originally appeared on The Upshot (copyright 2016, The New York Times Company).
A $30,000 price tag for cancer drug therapy that extends life only a few weeks is understandably alarming. But a $2,000 price tag for all childhood vaccines — credited with eradicating smallpox, preventing a million or more cases of other diseases and averting thousands of deaths each year — is a bargain. In fact, the price of childhood vaccines may be too low for our own good because it contributes to shortages.
Vaccine shortages have popped up in the United States many times over the past 50 years. In 2001, eight of 11 recommended childhood vaccines were unavailable or in short supply. A recently published study by the economist David Ridley and other Duke University researchers found that between 2004 and 2014, an average of nearly three out of 22 vaccines were in short supply in the United States. In 2007, one-third of vaccines were. (Looking globally, limited vaccine supplies hampered the response to a recent yellow fever outbreak that began in Angola and spread elsewhere.)
Vaccine prices have gone up over the years, in large part because of newer vaccines that command higher prices. The number of recommended vaccine doses has also increased, which pushes up the overall cost of full vaccination. Still, vaccines are inexpensive relative to their value. A typical dose costs $50 and, apart from an annual flu shot, only a few doses are required over a lifetime. According to the Duke study, vaccines with lower prices were more likely to be in short supply than those with higher prices. There were no shortages of vaccines with a price per dose above $75.
Low prices are implicated in vaccine shortages, just as they are for other injectable drugs delivered in hospitals and doctors’ offices. Generic injectables used for patients with serious illnesses and in emergencies also have low prices that contribute to shortages. But vaccines, unlike such injectables, are not generic. Vaccines are brand biologics (large-molecule, protein-based drugs made by living organisms, not by chemical processes), which normally command very high prices. So why are their prices low instead of high?
Vaccine prices are held down by government programs, which extendvaccinations to millions of children who might not otherwise get them. Federal and state programs buy more than half of childhood vaccine doses at a discount. The largest federal vaccine program — Vaccines for Children— may adjust prices within a year, but only downward, and it constrains changes in what it pays for some vaccines to below the overall inflation rate. Though the program keeps a six-month backup supply of vaccines on hand, the average shortage lasts three times that long, according to the Duke study.
Commercial market vaccine prices are higher than government ones, but not by enough to prevent shortages.
Low prices and concentrated buying power in government programs have pushed redundancy out of the market. There are only a few vaccine manufacturers, and some vaccines — including those for measles, mumps, rubella, varicella and shingles — are produced by just one. With little excess capacity, when a manufacturer experiences a problem requiring a shutdown, vaccine production falls below needed levels, causing a shortage. It can take years and close to a billion dollars to bring a new vaccine to the market, hardly a recipe for rapidly addressing a shortage.
“Manufacturers won’t invest in extra production capacity when prices are too low,” Mr. Ridley said.
Vaccines are among the most cost-effective treatments ever developed. Though most medical treatments don’t save money, vaccines do — preventing many diseases that would cost more to treat and allowing millions of people to live longer and more productive lives. Several studies have found that at even at 10 times their cost, vaccines would still save money.
We probably don’t need to raise vaccine prices by a factor of 10 to promote new vaccine investment and stabilize supply. According to one study, a doubling in price would incentivize new vaccine research, development and production.
For drugs as valuable as vaccines, that might be a price worth paying.
Is it ever okay to publicly shame someone on the internet? There are many cases where people have been persecuted online, and suffered severe consequences, based on accusations that are either trivial or false. But there may also be cases where public humiliation is merited, indeed, it may be the only way to address a grievous wrong. A letter accusing a prominent professor of sexual harassment is an important test case.
Thomas Pogge is the Leitner Professor of Philosophy and Professor of Political Science at Yale. Pogge has been accused of serial sexual harassment in an Open Letter signed by scores of his academic colleagues:
Pogge has engaged in a long-term pattern of discriminatory conduct, including unwanted sexual advances, quid pro quo offers of letters of recommendation and other perks, employment retaliation in response to charges of sexual misconduct, and sexual assault. [There are also] affidavits from former colleagues at Columbia University, who attest that Pogge was accused of sexual harassment by a student in his department, and disciplined for this.
Workplace sexual harassment is a serious form of wrongdoing, but it’s very common. So what makes this case news? It may be the identity of the accused. Pogge is an internationally famous political philosopher. He is an egalitarian, best known for having extended the work of his teacher, John Rawls, to issues of global justice. Sexual harassment, if he is guilty of it, is a striking betrayal of his public commitments to justice.
The Open Letter has an option for other academics to co-sign. I’ve spent a surprising amount of time considering whether I should.
The reason not to sign is that “trial by internet” is problematic.* There’s no due process or rights for the accused. Yale has an administrative procedure for handling harassment complaints and there is a way to get justice in the courts under Title VII of the Civil Rights Act. And, of course, not everything that you read on the internet is true. I was deeply shocked when I read the Rolling Stone article about the supposed gang rape at the University of Virginia, and shocked again when it was retracted.
Moreover, although I do not know Pogge personally, many of the authors of the Open Letter do. They include many leading moral philosophers, including other former students of Rawls (Elizabeth Anderson, Barbara Herman, and Joshua Cohen), and Pogge’s Yale colleagues Shelley Kagan and Stephen Darwall (chair of the Yale Department of Philosophy). In many cases of sexual misconduct, there is an ‘old boy’ network that seeks to hide the scandal and protect the institution. Not this time.
Pogge’s colleagues are also concerned that
bringing the complaint to resolution will be a long and complex process focused more on Yale’s handling of these claims, rather than on the specific allegations against Pogge. Meanwhile, the academic community must make its own decision about how to respond in light of what has been made public. We write, then, to express our belief that the information now in the public domain — including that provided by Pogge himself… — suffices to demonstrate that Pogge has engaged in behavior that violates the norms of appropriate professional conduct.
In short, Pogge is being read out of the community of ethics scholars. But I think that the authors of the Letter are concerned with more than Pogge. There is significant evidence that philosophy can be a particularly hostile environment for women (see accounts here, and the case of Colin McGinn). The authors may be hoping to reset the norms governing the treatment of women in philosophy and, perhaps, university faculties generally.
Finally, if we can’t judge others’ behaviour because we lack perfect instruments for determining the truth, we will never make or signal our moral judgments. Similarly, if we required that judicial proceedings be perfect instruments of truth, we would have no courts.
I signed the letter.
*I also have a concern about personal consistency when I stand in the crowd judging Pogge. What’s the metric that makes me a better person him? No, I haven’t sexually harassed (or cheated on, or assaulted!!!) anyone. But I can list many principles that I endorse in theory and betray in practice. For example, I believe:
That animal lives count. Yet I am a lapsed vegetarian.
That global warming is a serious threat. Yet I log a lot of air miles.
That current social and economic inequality is excessive. Yet I live in the North American 1% and have no plans to leave it.
[The list is indefinitely long.]
If I’m unfaithful to my professed beliefs, do I have standing to criticize Pogge?**
**[Releasing my inner David Foster Wallace, here’s a footnote to my footnote.] As we put Pogge into the stocks on the Commons, we need to ask ourselves whether we are the judges in The Scarlet Letter or The Crucible. Who are we to judge when we are, as Jonathan Edwards said, Sinners in the Hands of an Angry God?***
***And yet, if we can’t judge until we ourselves are perfect, there will be no moral progress.
6 Things That Happened in Health Policy This Week is produced by a mix of research assistants from the Healthcare Quality & Outcomes (HQO) Initiative at the Harvard T.H. Chan School of Public Health. In each edition we feature a variety of news articles, reports, and studies focused on U.S. health policy and health services research. This week’s edition is from Yevgeniy Feyman (@yfeyman), Zoe Lyon (@zoemarklyon) and Raj Pammal (@rspammal).
House Republicans have finally delivered on their promise to unveil a plan to replace the ACA— “A Better Way,” a 37-page white paper was released this week and includes a massive slew of health policy ideas repeatedly proposed by Republicans.
“A Better Way” would bring back high risk pools, would end open-ended funding for Medicaid, and would encourage small business to band together to increase bargaining power.
The white paper includes no specifics about how much any of this would cost or how it would be financed. There is also no mention of what would happen to the 20 million Americans who have gained coverage since the law took effect in 2010.
Along with huge cuts to the Medicaid program, the plan would repeal the exchanges and replace them with tax credits given to everyone buying policies in the individual market.
The proposal encourages the movement of Medicare beneficiaries out of the FFS service and into managed care plans, and would transition to a “premium support” financing structure that puts the cost-controlling burden more on private insurers.
Proponents of the ACA were quick to criticize Speaker Paul Ryan’s plan as recycled ideas to increase costs for seniors and take away health insurance from millions.
In 2014, more than 1,200 people died of an opioid overdose, according to the CDC.
In spite of that, Georgia has implemented a one-year moratorium (which began June 1st) on issuing new licenses to clinics that treat people addicted to opioids.
Georgia State Senator Jeff Mullis, who sponsored the legislation implementing this moratorium, questions why a large number of opioid treatment programs have opened in Georgia.
The state has 67 programs, compared to 12 in Tennessee, 24 in Alabama, and only one in Mississippi.
While opening a clinic in Georgia entails multiple licensing requirements from the federal and state governments, but Senator Mullis notes that Georgia doesn’t have a certificate of need requirement for clinics, unlike neighboring states.
Certificate of need laws operate in some 36 states, and typically require permission from state governments before opening new healthcare facilities, or expanding existing ones.
Critics of these clinics also argue that they simply have patients replace one drug for another.
Jonathan Connell, who heads the Opioid Treatment Providers of Georgia, believes that the moratorium is warranted. He argues that regulations of opioid clinics in the state are not well-enforced by the Georgia Department of Community Health.
The Department of Community Health has a small workforce of only three people to keep track of the 67 clinics.
The global drug lobbying group Biotechnology Innovation Organization (BIO) is accusing the Institute of Clinical and Economic Review (ICER) of being a shill for insurance companies.
ICER analyzes the cost-effectiveness of various drugs and treatments, and develops recommended prices based on their findings.
In a recent analysis of dozens of clinical trials, the group found that many treatments were overvalued at existing list prices.
Jim Greenwood, CEO of BIO, has called the group’s results “a completely arbitrary low-balled number.”
Drug companies have consistently pushed back against the group’s findings.
For the first time, the Centers for Medicare and Medicaid Services (CMS) has said that they may use ICER’s findings to change Medicare Part B reimbursement rates for drugs.
ICER receives about 10 percent of its funding from insurance companies, and has a number of prominent executives from insurance companies on its board. Funding from pharmaceutical manufacturers stands at 17 percent, and ICER has plans to add a new former pharmaceutical executive to its board in July.
BIO is planning to escalate its efforts against the group including more paid advertisements and “rapid-response.”
Attorney General Loretta Lynch announced a historic crackdown on Medicare fraud on Wednesday, with around 300 people being arrested.
The charges against the suspects range from taking illegal payments for marketing medications to false physical-therapy claims.
Other government programs have been implicated as part of this crackdown as well. In California, a man has been charged with receiving illegal payments from Tricare—a government program for active military members, vets, and their families—for marketing compound medications.
In New York City, other suspects included managers of physical therapy clinics that laundered money and billed Medicare and Medicaid for unnecessary treatments for patients.
Of most policy relevance is the hemorrhaging of money that comes as a result of the fraud; Lynch cited cases around the country where a wide variety of fraud has been found, with losses totaling around $900 million.
Elizabeth Warren (MA-D) and Richard Blumenthal (CT-D) are among seven Democratic U.S. Senators who wrote a letter to the Department of Justice’s antitrust division pressing it to block pending health insurance mega-mergers.
Specifically, the letter raised concerns over Aetna’s takeover of Humana, and Anthem’s acquisition of Cigna.
The letter stated that the merger of four of the five largest national health insurers would diminish competition, thereby increasing healthcare costs for consumers and business, and decreasing access to quality healthcare.
During the Obama administration, the Department of Justice has been quite active in blocking large-scale mergers that may harm consumers and competition.
Aetna and Anthem spokespeople countered the senators’ letter, with T.J. Crawford of Aetna affirming the company’s belief that a combined company is in the best interest of consumers.
On Wednesday, the Obama administration reported that Medicare’s hospital insurance trust fund (which pays for Medicare Part A benefits and Medicare Program administration) had deteriorated slightly in the past year, and that Social Security still faced serious long-term problems.
Trustees projected that Medicare’s hospital trust fund would be fully depleted by 2028, two years earlier than previously expected.
Despite claims from Obama administration officials that the Affordable Care Act has slowed the growth of health care spending, the report raised concerns over rising Medicare and Social Security costs, due to accelerating cost growth from the aging of the baby boom generation.
Congress took action last year to strengthen Social Security’s disability insurance trust fund, however, it is still estimated that the trust fund will be depleted by 2023.
As Medicare is expected to have an increase in average spending per beneficiary from $13,000 to $16,000 in the next five years, leaders from both parties are considering the idea of benefit cuts or tax increases for entitlement programs.
Come see what some of my colleagues and I are presenting at the forthcoming Academy Health Annual Research Meeting! The list below includes the talks and posters to be presented by me and my closest VA and Harvard colleagues and collaborators (plus Aaron). Just so you can tell them apart (if you care), the items marked with an asterisk (*) are by my VA colleagues. I marked Aaron’s with two asterisks (**).
Sunday, June 26:
10:30AM – 12:00PM:
The End of Journals (Carroll)**
12:15pm – 1:45pm:
Characterizing Recent Growth in the Medicare Advantage Program (Johnson)
Plan-Provider Integration in the Medicare Advantage Market (Lyon)
Progress and Challenges Facing Health Information Exchange Efforts Across the US (Adler-Milstein)
Concentration of Preventable Spending Among Medicare Subpopulations, (Figueroa)
Sensitivity of Inferences to Propensity Score Weight Choice: Kernel Versus Inverse Probability of Treatment (Garrido)*
2:00pm – 2:20pm:
Recent Growth in Medicare Advantage and Its Association with Subsequent Spending in the Medicare Fee-for-Service Program (Johnson)
Risk Prediction: Leveraging Longitudinal Data for Population Health (Garrido)*
Monday, June 27:
8:00am – 9:30am:
Relationship Between Emergency Department Admission Rate and Outcomes for Common Conditions Among Medicare Beneficiaries (Burke)
Do Academic Medical Centers Have a Differential Benefit for Medically Complex Medicare Beneficiaries? (Burke)
Trends in Emergency Department Practice Intensity Among Medicare Beneficiaries (Burke)
Global Budget Payments Led to a Decrease in Low-Value Hospital Admissions in Rural Maryland (Done)*
Hospital-Reported Strategies Associated with Better Patient Experience, (Figueroa)
Characteristics and Spending Patterns of the Non-Elderly High-Need/High Cost Patients in Massachusetts (Figueroa)
Five-Star Quality Rating in Dialysis Facilities: What Does the Patient Population of Highly Rated Facilities Look like? (Bonfrer)
Five-Star Quality Rating in Dialysis Facilities: What Do the High Performers Look like? (Bonfrer)
Pay for Performance in the US: Did Early Adopting Hospitals Perform Better? (Bonfrer)
Trends in Surgical Post-Operative Mortality: Are We Doing Better? (Mehtsun)
Unintended Consequences of the 30-Day Mortality Measure – Fact or Fiction? (Mehtsun)
Trends in Readmission Following Inpatient Surgery (Mehtsun)
Trends of Patient Experience in US Hospitals (Papanicolas)
10:05am – 10:25am:
Voluntary Health Insurance in Nigeria: Effects on Takers and Non-Takers (Bonfrer)
The Total Patient Revenue Program in Maryland Led to a Decrease in Rural Hospital Care Utilization (Done)*
11:50am – 12:10pm:
Greater Medicare Advantage Penetration Modifies the Relationship Between HIE and Medicare Spending (Adler-Milstein)
5:00pm – 5:20pm:
Changes in Care or Changes in Coding: Unintended Consequences of the Federal Pay-for-Performance Programs? (Papanicolas)
Propensity Scores with Multiple Treatment Levels (Garrido)*
Patient-Centered Validation and Maintenance of Performance Metrics Constructed from Administrative Data (Pizer, Prentice, Frakt)*
6:30pm – 8:00pm:
The Effects of Ghana’s National Health Insurance Scheme on Maternal Health Care Utilization (Bonfrer)
Tuesday, June 28:
8:00am – 9:30am
Using Survey and Administrative Data to Evaluate End-of-life Care Provision and Outcomes (Garrido, chair)*
One of the unfortunate adverse effects of the recent focus on the reproducibility of findings in research is that some people have developed less faith in the accuracy of science in general. This isn’t to say that a healthy skepticism isn’t warranted. In many ways, we’ve brought this problem on ourselves.
This is especially true when we discuss statistical significance. It’s bad enough that so few in the lay media and the public seem to understand it. It’s even worse that so many in science and science publishing fail to grasp its meaning.
The following originally appeared on The Upshot (copyright 2016, The New York Times Company).
After I wrote last year that diet, not exercise, was the key to weight loss, I was troubled by how some readers took this to mean that exercise therefore had no value.
Nothing could be further from the truth. Of all the things we as physicians can recommend for health, few provide as much benefit as physical activity.
In 2015, the Academy of Medical Royal Colleges put out a report calling exercise a “miracle cure.” This isn’t a conclusion based simply on some cohort or case-control studies. There are many, many randomized controlled trials. A huge meta-analysis examined the effect of exercise therapy on outcomes in people with chronic diseases.
Let’s start with musculoskeletal diseases. Researchers found 32 trials looking specifically at the effect of exercise on pain and function of patients with osteoarthritis of the knee alone. That’s incredibly specific, and it’s impressive that so much research has focused on one topic.
Exercise improved those outcomes. Ten more studies showed, over all, that exercise therapy increases aerobic capacity and muscle strength in patients with rheumatoid arthritis. Other studies proved its benefits in other musculoskeletal conditions, like ankylosing spondylitis, and even some types of back pain.
For people (mostly middle-aged men) who had had a heart attack, exercise therapy reduced all causes of mortality by 27 percent and cardiac mortality by 31 percent. Fourteen additional controlled trials showed physiological benefits in those with heart failure. Exercise has also been shown to lower blood pressure in patients with hypertension, and improve cholesterol and triglyceride levels.
People with diabetes who exercise have lower HbA1c values, which is the marker of blood sugar control, low enough to probably reduce the risk of complications from the disease. Twenty randomized controlled trials have showed that patients with chronic obstructive pulmonary disease can walk farther and function better if they exercise.
Multiple studies have found that exercise improves physical function and health-related quality of life in people who have Parkinson’s disease. Six more studies showed that exercise improves muscle power and mobility-related activities in people with multiple sclerosis. It also appeared to improve those patients’ moods.
The overall results of 23 randomized controlled trials showed that exercise most likely improves the symptoms of depression. Five others appear to show that it improves symptoms in patients with chronic fatigue syndrome. In trials, exercise even lessened fatigue in patients who were having therapy for cancer.
What other intervention can claim results like these?
Even studies of older, hospitalized patients show a beneficial effect from multidisciplinary interventions that include exercise. Those randomized to such interventions in the hospital were more likely to be discharged to go home, and to spend less time in the hospital over all — and at a lower cost.
Although we don’t think of it this way, you can make a pretty good argument that exercise is as good as drugs for many conditions. A 2013 meta-analysis of meta-analyses (that’s how much data we have) combined and analyzed the results from 16 reviews of randomized controlled trials of drug and exercise interventions in reducing mortality. Collectively, these included 305 trials with almost 340,000 participants.
Diuretic drugs (but not all drugs) were shown to be superior to exercise in preventing death from heart failure. But exercise was found to be equally good as drugs in preventing mortality from coronary heart disease. Exercise was better than drugs in preventing death among patients from strokes.
Many people will be surprised at how little you need to do to achieve these results. Years ago, in an effort to get in shape, I tried the P90X routine. It proved too hard for me. Later, when I tried the Insanity workout, it beat me so badly that people at work kept asking me if I was ill. Two years ago, I tried P90X3. It was a bit more manageable, but I still couldn’t keep it up.
I have not been alone in thinking that physical activity to improve health should be hard. When I hear friends talk about exercising, they discuss running marathons, participating in cross-fit classes or sacrificing themselves on the altar of SoulCycle. That misses the point, unfortunately. All of these are much more than you need to do to get the benefits I’ve described.
The recommendations for exercise are 150 minutes per week of moderate intensity physical activity for adults, or about 30 minutes each weekday.
Moderate intensity is probably much less than you think. Walking briskly, at 3 to 4 miles per hour or so, qualifies. So does bicycling slower than 10 miles an hour. Anything that gets your heart rate somewhere between 110 and 140 beats per minute is enough. Even vacuuming, mowing the lawn or walking your dog might qualify.
Today, my goals are much more modest. Trekking from my office to the clinic and back again gives me 30 minutes of exercise. Or, I walk to the supermarket from my office to grab lunch, at a mile each way. In colder weather, I spend half an hour on the elliptical machine. Doing this five days a week gets me the activity I need.
Although it feels as if there’s nothing we can do to change people’s behavior, there is evidence to the contrary. A systematic review and meta-analysis of advice and counseling by health professionals found that promotion of physical activity works.
Doctors and clinics that made efforts to promote exercise to patients needed to engage 12 adults on the subject to get one additional adult to meet recommended levels of activity one year later. That might not sound impressive, but it’s one of the better such results.
After the Academy of Medical Royal Colleges wrote its report, an editorial in the BMJ, a prominent medical journal, countered that exercise wasn’t a “miracle cure.” Instead, the authors argued it was “the best buy for public health.”
If that’s the best “counterpoint,” then physical activity seems like a no-brainer.
Austin and Aaron are participants in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to amazon.com.