Via Michael Eddy:
Amazing health effects of texting people with significant cardiovascular disease! This is Healthcare Triage News.
For those of you who want to read more, the paper is “Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial“.
In my third post in my series on how bad people are at choosing health plans, I continue to summarize studies relating to commercial market plans, which I started in my second post. (See post 1 for research pertaining to Medicare plans.) My third post is on the AcademyHealth blog. Go read it!
Consider DuoNeb, which is used to treat chronic lung disease. The drug is nothing fancy: it’s just a combination of two cheap and widely available drugs—albuterol and ipratropium.
You can pop DuoNeb in a nebulizer and administer both drugs at once. Or you can administer the two drugs separately. Apart from mild inconvenience, there’s no reason to pick DuoNeb over the two-drug sequence. And there’s good reason not to pick DuoNeb: a single dose is more expensive than one dose each of albuterol and ipratropium.
Sensitive to the cost concern, Medicare announced in 2008 that it wouldn’t pay for the full costs of DuoNeb. (Because DuoNeb is administered through a nebulizer, which is considered durable medical equipment, it’s covered under Medicare Part B, not Part D.) Medicare would instead pay the combined price of the two component drugs—what it called the “least costly alternative.” Because … duh. It’s cheaper.
The court’s reasoning was based on the language of the Medicare statute. As the court saw it, the statute puts Medicare to a “binary choice.” Either DuoNeb isn’t covered at all or it’s covered at the full statutory rate, which is 106% of the average sales price. What Medicare can’t do is cover DuoNeb but pay less than the statutory rate.
The trouble is that Medicare had no choice but to cover DuoNeb. By statute, Medicare can refuse to cover a medical treatment that is “not reasonable and necessary for the diagnosis or treatment of illness or injury.” The language is a little squirrelly: it’s plausible to think that a given treatment is “not reasonable” if an equally effective alternative is much cheaper.
For now, however, Medicare reads the statute to preclude it from considering costs in making coverage decisions. If DuoNeb provides a medical benefit—and it does—then it’s covered, costs be damned. And once it’s covered, the D.C. Circuit reasoned, Medicare had to pay full freight.
This is, in a word, stupid. Not the court’s decision, which I think is probably right. What’s stupid is that the law prevents Medicare from making common-sense decisions about how to spend taxpayer money. If we can’t fix a problem as easy as DuoNeb, we’ve got our work cut out for us.
From the NEJM, “Randomized Trial of Reduced-Nicotine Standards for Cigarettes“:
BACKGROUND: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes.
METHODS: We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6.
This study is a lesson in simplicity. They rounded up smokers at least 18 years old, meaning that they smoked five or more cigarettes a day. Interestingly, they also had to have no current interest in quitting. That’s different than most studies, that focus on people who want to stop. These people were less motivated, therefore, and less likely to actually quit.
They were then assigned to either smoke their usual cigarettes (placebo), or one of six study cigarettes, ranging from 15.8 mg nicotine/g tobacco (which is comparable to commercial brands) to 0.4 mg/g, which is obviously much less. After 6 weeks, the researchers checked to see how many cigarettes they were smoking per day.
They randomized 840 people, and 780 completed the study. Those who were given the low-nicotine cigarettes (0.4, 1.3, and 2.4 mg/g) smoked fewer cigarettes per day than those who smoked their usual brand:
The researchers also measured “dependence”, using the Wisconsin Inventory of Smoking Dependence Motives and the Fagerström Test for Nicotine Dependence. Those smoking the low-nicotine cigarettes showed less dependence, achieving significance at the lowest nicotine levels.
Finally, they did an abstinence assessment, where they asked them not to smoke for at least 18 hours and then report on symptoms. There were no differences in withdrawal symptoms from the different cigarettes, but those smoking the low-nicotine cigarettes reported significantly reduced cravings for a cigarette.
Many readers will wonder why, then, “light” cigarettes haven’t been pushed by health advocates. Most of those don’t contain tobacco with less nicotine; they have holes in the filter which bring in more air with inhalation and don’t seem to generate the same results. In fact, some think that people compensate when they smoke those by taking bigger puffs. In this study, using actual low-nicotine tobacco, that compensation didn’t occur.
As the accompanying editorial notes, smoking kills half of the people who smoke in the long run, usually 10-15 years earlier than they otherwise might have died. As a prominent researcher, Michael Russell, wrote, “People smoke for nicotine but they die from the tar”. If we reduce the nicotine, people may smoke less. They might also quit.
This study didn’t measure that. It also was only 6 weeks long, and long-term effects are unknown. But a longer study is in the works, and twice as many people smoking the low-nicotine cigarettes in this trial attempted to quit in the month after it was over than those who smoked their regular cigarettes.
The FDA was empowered to start regulating nicotine content in 2009. To date, they haven’t done anything. It’s likely this trial isn’t enough to make them start. But more confirmatory work might.
I’ve been standing at my workstation for several years, and there’s no way I’d go back to sitting all day. I’m much more comfortable standing (less back/neck/arm discomfort, resulting in a better mood). But that’s as close as I’d get to a health claim. I don’t think it’s making me fitter or adding years to my life. If you’re looking for a massive productivity or health boost from your standing desk, a 2014 systematic review may disappoint you.
It concludes that standing and treadmill desks probably offer some health value, more so for obese users, but the evidence isn’t strong and there are hedge words all over the conclusion (my emphasis):
Based on the empirical evidence of current literature, this review concludes that standing and treadmill desks are potentially useful in reducing workplace sedentariness while having a positive influence on workplace stress and overall mood. The treadmill desk provides the greatest physiological improvements and is most beneficial for overweight and obese participants. However, the use of a treadmill desk results in larger decreases in work productivity and motor abilities than the standing desk.
Standing desk use does not elicit the same physiological impact as the treadmill desk but does result in the least change in productivity and motor abilities. Of the standing desks, a sit–stand desk seems to provide the most benefit allowing the employee to adjust their desks throughout the day. The standing-only desk could potentially result in additional complications with musculoskeletal conditions and feelings of fatigue and discomfort.
Overall, current evidence suggests that both standing and treadmill desks may be effective in improving overall health considering both physiological and mental health components. However, at present there still exist substantial gaps in the research to fully comprehend the utility of each type of desk to promote health.
I thank Aaron for sending me this review. I still love my standing desk.
Two new studies from the BMJ. The first is “Calcium intake and risk of fracture: systematic review“:
Objective To examine the evidence underpinning recommendations to increase calcium intake through dietary sources or calcium supplements to prevent fractures.
Design Systematic review of randomised controlled trials and observational studies of calcium intake with fracture as an endpoint. Results from trials were pooled with random effects meta-analyses.
Data sources Ovid Medline, Embase, PubMed, and references from relevant systematic reviews. Initial searches undertaken in July 2013 and updated in September 2014.
Eligibility criteria for selecting studies Randomised controlled trials or cohort studies of dietary calcium, milk or dairy intake, or calcium supplements (with or without vitamin D) with fracture as an outcome and participants aged >50.
The MIC would have you believe that drinking milk (ie increasing your dietary calcium intake) will protect your bones. This was a systematic review to look at RCTs or observational studies to see if that’s the case, with fracture as the endpoint. Participants had to be at least 50 years old.
They found only two RCTs of dietary calcium intake increases, with 262 participants total. There were, however, 44 cohort studies of calcium (37), milk (14), or dairy intake (8).
Let’s take calcium first. Most studies found no relationship between intake and fracture (17/21 for hip, 7/8 for vertebral, 5/7 for forearm, and 14/22 for total). For dairy, 11/13 found no association. For milk, 25/28 studies found no association. The milk emperor has no clothes.
Let’s try calcium supplementation, not from diet. There were 26 RCTs. Supplementation did reduce total fractures (RR 0.89) and vertebral fractures a little bit (RR 0.96). But there was no protection against hip or forearm fractures.
All studies were not of similar quality, though. When they considered the four RCTs at lowest risk of bias, no effect of fracture protection was seen at all, in any site.
Similar (disappointing) results were seen for calcium monotherapy and co-administered calcium and vitamin D.
Conclusion? Dietary calcium isn’t associated with a risk of fracture. There’s no evidence that increasing dietary calcium prevents fracture. Even the evidence that says that calcium supplementation prevents fracture is weak.
Objective To determine whether increasing calcium intake from dietary sources affects bone mineral density (BMD) and, if so, whether the effects are similar to those of calcium supplements.
Design Random effects meta-analysis of randomised controlled trials.
Data sources Ovid Medline, Embase, Pubmed, and references from relevant systematic reviews. Initial searches were undertaken in July 2013 and updated in September 2014.
Eligibility criteria for selecting studies Randomised controlled trials of dietary sources of calcium or calcium supplements (with or without vitamin D) in participants aged over 50 with BMD at the lumbar spine, total hip, femoral neck, total body, or forearm as an outcome.
Pretty much the same study, but with bone density (not fracture) as the outcome of interest. In this case, though, they stuck to RCTs. They found 59 of them, both for dietary calcium (15) and calcium supplementation (51).
Increasing dietary calcium intake did increase bone mineral density (BMD) by 0.6-1.0% both at the hip and total body at one year. It also increased BMD there and at the lumbar spine and femoral neck by 0.7-1.8% at two years. It had no effect on the forearm.
Calcium supplementation increased BMD all over by 0.7-1.8% at one, two, and 2.5 years.
But these changes, while statistically significant, are unlikely to lead to any meaningful outcomes. They certainly don’t protect against fracture (see first study).
From the accompanying editorial, entitled “Calcium supplements do not prevent fractures”
By use of guidelines such as those by NOF and the International Osteoporosis Foundation (IOF), marketing now extends to all older people with dietary intakes below the recommended 1200 mg calcium and 800-1000 IU vitamin D daily. By this definition virtually the whole population aged over 50 is at risk. Most will not benefit from increasing their intakes and will be exposed instead to a higher risk of adverse events such as constipation, cardiovascular events, kidney stones, or admission for acute gastrointestinal symptoms. The weight of evidence against such mass medication of older people is now compelling, and it is surely time to reconsider these controversial recommendations.
Go tell the Milk Emperor.
I’m sure few TIE readers have failed to notice that there’s a ton of discussion of drug prices and price control policies these days. Could the mere consideration of such policies cause price reductions, perhaps by manufacturers trying to avoid the bad PR that could turn discussion into legislative action?
Work by Ellison and Wolfram suggests the answer is “yes.” They examined drug prices during the run up to and through the early 1990s efforts at national health reform. One of the policy ideas in 1993 was to push drug prices downward via purchasers with massive market clout. In particular, Medicare was to add prescription drug coverage to its benefit package and use its massive size to negotiate discounts. (Sound familiar?)
The data suggest that this spooked the drug industry. While the health reform package was being formulated, pharma stocks fell 40%, Ellison and Wolfram wrote. Here’s their look at what happened to prices, by various measures (defined under the chart):
In the chart, “PPI” and “CPI” are the producer and consumer price index for pharmaceutical products; “CPI overall” is the CPI for all products; “Top 106” is a set of the 106 largest revenue drugs in the 1990s; “antibiotics” are “virtually all” antibiotics sold from 1990-1996.
From 1991 through 1996, overall CPI growth was steady, but by all drug measures, drug price growth fell, and dramatically so just as health reform was being formulated. In particular, broad measures of drug price growth were nearly pegged to overall inflation growth from 1993-1996.
Growth in drug R&D took a hit too, as shown in the following chart. As a percent of sales, it flattened in the early 1990s. Annual change went negative in 1994.
The authors conclude,
The results presented here suggest that there was a political component to pharmaceutical pricing during the health care reform debates. In particular, the firms we identified as more politically sensitive were more likely to engage in coordinating pricing, consistent with a pledge many firms made not to raise prices more than the rate of inflation.
A caveat is that most of the action was restricted to wholesale prices, though some filtered through to transaction prices. A lesson is that merely the threat of policy change can affect prices and R&D investment. Talk is still cheap, but perhaps not as cheap as we may think.
Two recent studies published in JAMA bring more data to the debate over how prevalent and meaningful gender disparities are in academic medicine. I explore both of them, and more, in my latest post over at the AcademyHealth blog.
This is a TIE-U post associated with Nick Bagley’s Health Reform and Its Legal Controversies (Michigan Law 866, Fall 2015). For related posts, see the course intro.
After NFIB v. Sebelius, the states gained a lot of leverage in their negotiations with the federal government over whether to expand their Medicaid programs. A handful have used that leverage to negotiate deals with CMS over the rules governing their expansions.
Arkansas cut perhaps the most interesting deal—the so-called “private option.” (Adrianna, Austin, and Aaron have covered it extensively here, here, here, here, here, and here.) Instead of channeling the expansion money into traditional Medicaid plans, Arkansas uses it to allow newly covered individuals to buy health plans on the exchange. Iowa has followed Arkansas’s lead and New Hampshire is following suit in 2016.
But there’s a problem. Because Medicaid doesn’t pay all that well, health plans on the exchanges are more expensive than Medicaid plans. It stands to reason that channeling the expansion population to the exchanges will cost more—much more, in fact—than a conventional expansion. At the same time, CMS has adopted a rule saying that the private option “must be comparable to the cost of providing direct coverage” through Medicaid. Otherwise, CMS won’t approve it.
How did Arkansas clear the cost-neutrality hurdle? When it submitted its plan, Arkansas didn’t compare the cost of the private option to the cost of expanding the Medicaid program that it already had in place. Instead, Arkansas compared the cost of the private option to the cost of expanding a Medicaid program that paid the same amount as private providers. Voilá: both options would cost the same.
Arkansas justified this accounting trick by pointing out that expansion would swell the rolls of Medicaid beneficiaries, which would in turn increase demand for health care. Unless Arkansas boosted its payment rates, it feared that not enough physicians and providers would participate in Medicaid to meet that increased demand. Hence the need to pay at parity with private plans.
Tellingly, though, Arkansas submitted no data to support this assumption. Nor did CMS ask for any. So far as I can make out, no one (including Austin) thinks the assumption is realistic. Even Arkansas, when it toyed with a conventional expansion, anticipated keeping Medicaid payment rates the same.
But CMS bought it. The reason is simple. For Arkansas, the choice wasn’t between the private option and a traditional Medicaid expansion. The choice was between the private option and no expansion at all. The agency’s desire to move another state onto the “yes” column trumped the scrupulous enforcement of its cost-neutrality rule.
All this has been said before; GAO wrote a whole report about it. But the practice raises a concern for the future. Under section 1332 of the ACA, a state can get a waiver from most of the ACA’s new rules so long as the state’s alternative scheme will cover as many people without increasing the federal deficit.
The Arkansas experience supplies a precedent for neglecting these constraints on §1332 waivers. (I’m not the first to make the point; Adrianna made it in a paper she wrote when she was still in graduate school.) Instead of insisting on realistic assumptions and careful economic modeling, HHS could again emphasize the importance of state innovation and approve state plans that fudge the numbers.
In the hands of president who’s hostile to the ACA, waivers could become an instrument for watering down the substantive ACA provisions in states that bridle at their perceived excesses. Complaints about unrealistic assumptions in waiver applications could be brushed aside as political sniping: if President Obama looked the other way for the Medicaid expansion, why can’t President Rubio do the same for the rest of the ACA?
Perhaps tellingly, the state that’s expressed the most concrete interest in §1332 waivers is … Arkansas. “Our hope is that we can get flexibility with the Obama administration,” said one Arkansas official. “But if we can’t get the flexibility that we want, we believe that a Republican administration would be a lot more flexible.” Indeed.