• Healthcare Triage: The Acrylamide in Coffee Won’t Give You Cancer, CALIFORNIA

    A judge in California recently ruled that coffee would be required to carry a carcinogen warning label, since it contains acrylamide. Well, have the barista make you a double espresso with a shot of evidence, because that coffee probably isn’t going to give you cancer.

    This episode was adapted from a column I wrote for The Upshot. Links to sources can be found there.

    @aaronecarroll

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  • JAMA Pediatrics Podcast: Women exposed to endocrine disruptors during pregnancy may have *grandchildren* with neurodevelopmental deficits.

    As you know, I’m now the Web and Social Media Editor at JAMA Pediatrics. We’ve got a podcast where I discuss a paper from the journal. I do my best to pick good ones.

    Please consider giving this a listen, and subscribe! Doing so makes it more likely that I’ll be able to keep doing this.

    This week, I’m covering “Association of Exposure to Diethylstilbestrol During Pregnancy With Multigenerational Neurodevelopmental Deficits”:

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  • Medical Mystery: Something Happened to the U.S. Health System After 1980

    The following originally appeared on The Upshot (copyright 2018, The New York Times Company). Research for this piece was supported by the Laura and John Arnold Foundation.

    The United States devotes a lot more of its economic resources to health care than any other nation, and yet its health care outcomes aren’t better for it.

    That hasn’t always been the case. America was in the realm of other countries in per-capita health spending through about 1980. Then it diverged.

    It’s the same story with health spending as a fraction of gross domestic product. Likewise, life expectancy. In 1980, the U.S. was right in the middle of the pack of peer nations in life expectancy at birth. But by the mid-2000s, we were at the bottom of the pack.

    What happened?

    Health spending and life expectancy are not necessarily closely related, so it’s helpful to consider them separately.

    “Medical care is one of the less important determinants of life expectancy,” said Joseph Newhouse, a health economist at Harvard. “Socioeconomic status and other social factors exert larger influences on longevity.”

    For spending, many experts point to differences in public policy on health care financing. “Other countries have been able to put limits on health care prices and spending” with government policies, said Paul Starr, professor of sociology and public affairs at Princeton. The United States has relied more on market forces, which have been less effective.

    “Confronted with fiscal pressures, as the share of G.D.P. absorbed by health care spending began to get serious, other nations had mechanisms to hold down spending,” said Henry Aaron, a health economist with the Brookings Institution. “We didn’t.”

    One result: Prices for health care goods and services are much higher in the United States. Gerard Anderson, a professor at Johns Hopkins and a lead author of a Health Affairs study on the subject, emphasized this point. “The differential between what the U.S. and other industrialized countries pay for prescriptions and for hospital and physician services continues to widen over time,” he said. Other studies also support this idea. However, by some measures, growth in the amount of health care consumed has also been a factor.

    The degree of competition, or lack thereof, in the American health system plays a role. A recent study by economists at the University of Miami found that periods of rapid growth in U.S. health care spending coincide with rapid growth in markups of health care prices. This is what one would expect in markets with low levels of competition.

    Although American health care markets are highly consolidated, which contributes to higher prices, there are also enough players to impose administrative drag. Rising administrative costs — like billing and price negotiations across many insures — may also explain part of the problem.

    The additional costs associated with many insurers, each requiring different billing documentation, adds inefficiency, according to the Harvard health economist David Cutler. According to a recent study, the United States has higher health care administrative costs than other wealthy countries.

    “We have big pharma vs. big insurance vs. big hospital networks, and the patient and employers and also the government end up paying the bills,” said Janet Currie, a Princeton health economist. Though we have some large public health care programs, they are not able to keep a lid on prices. Medicare, for example, is forbidden to negotiate as a whole for drug prices, as Ms. Currie pointed out.

    But none of this explains the timing of the spending divergence. Why did it start around 1980?

    Mr. Starr suggests that the high inflation of the late 1970s contributed to growth in health care spending, which other countries had more systems in place to control. Likewise, Mr. Cutler points to related economic events before 1980 as contributing factors. The oil price shocks of the 1970s hurt economic growth, straining countries’ ability to afford health care. “Thus, all across the world, one sees constraints on payment, technology, etc., in the 1970s and 1980s,” he said. The United States is not different in kind, only degree; our constraints were weaker.

    Later on, once those spending constraints eased, “suppliers of medical inputs marketed very costly technological innovations with gusto,” Mr. Aaron said. They “found ready customers in hospitals, medical practices and other entities eager to keep up with rivals in the medical arms race.”

    The last third of the 20th century or so was a fertile time for expensive health care innovation. Sherry Glied, an economist and a dean at New York University, offered a few examples: “Coronary artery bypass grafting took off in the mid-to late 1970s. Later, we saw innovations like drug treatments for H.I.V. and premature babies.”

    These are all highly valuable, but they came at very high prices. This willingness to pay more has in turn made the United States an attractive market for innovation in health care.

    Yet being an engine for innovation doesn’t necessarily translate into better outcomes. Almost no matter how it’s measured, longevity in the United States has not kept pace with that of other nations. Again, the inflection point is around 1980. Why?

    A study examining the period 1975 to 2005 by Ms. Glied and Peter Muennig, from Columbia, suggests that international differences in rates of smoking, obesity, traffic accidents and homicides cannot explain why Americans tend to die younger.

    Some have speculated that slower American life expectancy improvements are a result of a more diverse population. But Ms. Glied and Mr. Muennig found that life expectancy growth has been higher in minority groups in the United States. Another study, published in JAMA, found that even accounting for motor vehicle traffic crashes, firearm-related injuries and drug poisonings, the United States has higher mortality rates than comparably wealthy countries.

    The lack of universal health coverage and less safety net support for low-income populations could have something to do with it, Ms. Glied speculated. “The most efficient way to improve population health is to focus on those at the bottom,” she said. “But we don’t do as much for them as other countries.”

    The effectiveness of focusing on low-income populations is evident from large expansions of public health insurance for pregnant women and children in the 1980s. There were large reductions in child mortalityassociated with these expansions. “Those reductions were much larger for poor children than for richer children,” Ms. Currie said.

    A report by RAND shows that in 1980 the United States spent 11 percent of its G.D.P. on social programs, excluding health care, while members of the European Union spent an average of about 15 percent. In 2011 the gap had widened to 16 percent versus 22 percent.

    Although this is a modest divergence over time, Mr. Anderson says it could be significant nonetheless. “Social underfunding probably has more long-term implications than underinvestment in medical care,” he said. For example, “if the underspending is on early childhood education — one of the key socioeconomic determinants of health — then there are long-term implications.”

    Slow income growth could also play a role because poorer health is associated with lower incomes. “It’s notable that, apart from the richest of Americans, income growth stagnated starting in the late 1970s,” Mr. Cutler said.

    Even if we can’t fully explain why the United States diverged in terms of health care spending and outcomes after 1980, one thing is clear: History demonstrates that it is possible for the U.S. health system to perform on par with other wealthy countries. That doesn’t mean it’s a simple matter to return to international parity. A lot has changed in 40 years. What began as small gaps in performance are now yawning chasms. And, to the extent greater American health spending has spurred development of valuable health care technologies, we may not want to trade away all of our additional spending.

    Nevertheless, Ashish Jha, a physician with the Harvard T.H. Chan School of Public Health and the director of the Harvard Global Health Institute, is hopeful: “For starters, we could have a lot more competition in health care. And government programs should often pay less than they do.” He added that if savings could be reaped from these approaches, and others — and reinvested in improving the welfare of lower-income Americans — we might close both the spending and longevity gaps.

    @afrakt

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  • Healthcare Triage: Backwards Car Seats are Pretty Swede, But We Can Do More to Keep Kids Safer

    Rear-facing car seats do keep kids safer, but they can be hard to use for larger children. In Sweden, kids stay in backward facing seats a lot longer, and have fewer injuries. The study that encouraged American parents to turn their car seats around turned out to be flawed. But that doesn’t mean it’s not a good idea!

    This episode was adapted from a column I wrote for the Upshot. Links to sources can be found there.

    @aaronecarroll

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  • JAMA Pediatrics Podcast: Solar-Powered Oxygen Delivery in Low-Resource Settings

    As you know, I’m now the Web and Social Media Editor at JAMA Pediatrics. We’ve got a podcast where I discuss a paper from the journal. I do my best to pick good ones.

    Please consider giving this a listen, and subscribe! Doing so makes it more likely that I’ll be able to keep doing this.

    This week, I’m covering “Solar-Powered Oxygen Delivery in Low-Resource Settings: A Randomized Clinical Noninferiority Trial”:

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  • Upshot extra: Something happened in the 1980s

    I’m very proud of my Upshot post today, which explores a US health care mystery: our levels of spending and outcomes were among those of peer nations until the early 1980s. Then things went kaflooey (to put it technically). Why?

    You can see it in the charts in the piece and read why Joe Newhouse, Paul Starr, Henry Aaron, Garard Anderson, Janet Currie, Sherry Glied, and Ashish Jha think things went sideways around then.

    This piece was a ton of work, and I thank Stephanie Caty at the Harvard T.H. Chan School of Public Health for chasing down the data for the charts. Lest you think I was cherry picking the data, the two charts in the piece are far from the only ones that illustrate the phenomenon. Below is one more on outcomes, that appeared in Nicholas Kristof’s piece last summer. It shows that reductions in the rate of maternal deaths during childbirth ceased in the US in the 1980s, and then started to increase in the 1990s. That did not happen in Japan, Italy, Germany, Britain, Sweden, Ireland, or France (Canada has a pattern most similar to ours).

    Below is another chart that makes one think about the mechanism. It shows that the growth in annual income of the top 1% took off in the 1980s. Other quantiles of income have either held steady or increased less rapidly. 

    Now, this is pure speculation, but maybe our health system caters to the wealthy. As their incomes grow, so does their demand for ever more expensive, high-tech care that is only marginally better than what came before. Political and social influence being what it is, they get it, but we all pay for it. The share of our economy going to health care grows. But outcomes for the vast majority of the population with lower incomes don’t improve as much, because more high-tech, expensive, low value health care isn’t what they need as badly as they need higher wages, better education, better housing — things provided by other social programs that the health care budget is consuming.

    Again, pure speculation, suggested by the charts but not at all proved by them. Anyway, there are tons more charts that show things about the health care system went off the rails in the 1980s. I could do this all day. Go read my Upshot post.

    Research for this piece and The Upshot post it promotes was supported by the Laura and John Arnold Foundation.

    @afrakt

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  • A market-based approach to address drug prices

    In advance of President Trump’s announcement on drug prices (twice delayed, but expected today), I have a post up at Bloomberg View that discusses a market-based approach that is gaining traction.* That’s not to say that some additional action from Congress or the administration wouldn’t be worthwhile (and we can debate what that should be). But let’s not overlook other, non-governmental organizations.

    [T]he biggest problem is that it’s hard to generate enough reliable cost-effectiveness information to give insurers the leverage to say “no” to unreasonably expensive drugs. […]

    The nonprofit and privately financed Institute for Clinical and Economic Review has proposed a way to solve that problem. Largely funded by the Laura and John Arnold Foundation, it is an independent organization that weighs the benefits of medical technologies against their prices.

    For each new drug that comes to market, the organization conducts a clinical and economic analysis that’s available to the public. It then suggests to payers and manufacturers a price range that’s aligned with benefits and budgets.

    There’s evidence that the exercise is helping insurers cut better deals.

    The piece provides several examples, which you can go read about. But here’s the most important point:

    By providing cost-effectiveness analysis to the market, ICER is not facilitating what many patient advocates and drug manufacturers fear — reducing access to lifesaving treatments. Instead, it is helping to expand it through voluntary exchange in a market, not government price control.

    Bringing information to the market that demonstrates that proposed launch prices are way out of line may shame drug manufacturers into coming to the bargaining table. Working with payers to remove barriers to access in exchange for lower prices helps seal the deal. It’s a carrot and stick approach that addresses the worst drug-pricing excesses. Finally.

    * As acknowledged in the Bloomberg View piece, research for it was supported by the Laura and John Arnold Foundation.

    @afrakt

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  • Innovative and Value-based Approaches to Confronting High Drug Prices

    Gilbert Benavidez is a Policy Analyst with Boston University’s School of Public Health. He tweets at @GBinsolidarity Research for this piece was supported by the Laura and John Arnold Foundation.

    The vast majority of American voters want Congress to focus on reducing drug prices. One avenue growing in popularity, even in the absence of congressional action, is to tie the price of a drug to the good it provides to patients. There are several approaches, as well as some limitations.

    Outcome-Based Pricing contracts (OBPCs) work via a reimbursement scheme: When a drug doesn’t work as well as expected, the payer is refunded a portion of the drug’s price. Outcome-based pricing has garnered press with exciting and novel drugs like Spark’s Luxturna (Voretigene neparvovec) or Amgen’s Repatha (Evolocumab). Research from Nazareth et al. suggests that a moderate amount of outcome-based contract growth should be expected in the United States.

    In a February 2018 report, the Pharmaceutical Research and Manufacturers of America (PhRMA) working with the consulting firm Avalere, argued that outcome-based contracts have the potential to both improve patient outcomes by broadening access to innovative medicines and reducing their cost to payers. The report provided a formulary analysis of 2015-2017 Silver level Marketplace plans that showed plans with OBPCs had 28% lower copayments compared to plans with traditional contracts (Figure 4 of the report). The report also found that 38% of payers with OBPCs had improved patient outcomes, 33% experienced cost savings, and 70% of health plans report they have favorable attitudes toward outcome-based contracts.

    On the other hand, Kaltenboeck and Bach of Sloan Kettering’s Drug Pricing Lab argued that prices of drugs currently offered through outcomes-based contracts, like Amgen’s with Harvard Pilgrim for Repatha, have “…nothing to do with the benefits of the drug.” Separately, Harvard researchers Seeley and Kesselheim wrote: “There is no evidence to date that the rebates will result in lower drug prices…” They speculate that the rebate may be factored into the pre-rebate price. This conclusion leads naturally to another option:

    Value-Based Pricing (VBP) ties the price of a drug to the value it provides for the population for whom it is indicated. The Institute for Clinical and Economic Review (ICER) is one independent body that estimates VBPs with standard cost-effectiveness calculations that produce a price for which a drug would yield a quality adjusted life year for typical thresholds, like $150,000. (In separate steps, ICER also takes into consideration budget impact, as well as other benefits, disadvantages, and ethical and contextual factors, all deliberated in an open, public process.)

    Kaltenboeck and Bach compared the effective price of Repatha in the Amgen-Harvard Pilgrim OBPC with the (ICER) estimates for the drug’s value and found that Harvard Pilgrim’s price is substantially higher ($14,100 vs. $2,200-5,000).

    ICER has had some success in both establishing value and informing prices. For example, in March 2018, ICER evaluated the PCSK9 inhibitor Praluent (Alirocumab), arriving at a value-based price of

    $2,300-$3,400 per year if used to treat all patients who meet trial eligibility criteria and $4,500-$8,000 per year if used to treat higher-risk patients.

    As a result of this, Regeneron and Sanofi offered to lower Praluent’s cost to be in line with the valuation if payers, like Express Scripts, approved treatments for patients more quickly and with fewer barriers. Notably, Amgen stood by Repatha’s price as is. This decision, as I wrote last week, resulted in the drug being strategically cut from Express Script’s formulary in favor of Praluent.

    Indication-Specific Pricing (ISP) is a further application of value-based pricing. ISP contracts acknowledge that the same drug may provide different benefits for different diseases. For example, Tarceva (Erlotinib) is used to treat non-small-cell lung cancer and pancreatic cancer. However, effectiveness for the two indications is very different, as the median survival gain when treating the former is 3.4 months but only 1.4 weeks for the latter. Under indication-specific pricing, the price for the drug would be sensitive to its effectiveness for each disease it treats, in theory linking the indication-based usage of the drug to the ascertained value.

    CVS Caremark has adopted an indication-based model for drugs for some conditions like Hepatitis C (Hep C). This model informs what is included in its formulary. As I wrote last week, manufacturers are incentivized to lower prices of drugs, like those for Hep C, during negotiation with CVS, lest they be left out of formulary in favor of a more clinically effective and cost appropriate drug for the Hep C indication.

    Though ISP contracts have potential, Pearson, et al. acknowledge barriers to implementation. One is that the Medicaid best price rule may cause interference. Essentially, Medicaid pays the lowest price on the market for any particular drug. If a certain indication for a drug substantially lowers that drug’s price, the best price rule necessitates that Medicaid pay that price for the drug. Sachs, et al. explain that companies could get around this by entering contracts with a weighted average price, rather than different prices for indications. Alternatively, companies can also engage in “product differentiation,” which is essentially turning one drug into two. The two drugs can be used for two different indications, shedding best-price rule interference.

    Another issue for ISPs is that the indication for each prescription may not be known by pharmacies because clinicians are not always required to provide it on prescriptions. Even when indication is known, it must be verified so that payers are sure they’re paying for the right indication. Because of this, the authors raised the concern that “few payers currently have the data capabilities to implement ISP models that require patient-level information.” They wrote that these issues can be addressed by utilizing claims data and improved data systems.

    Chandra and Garthwaite wrote in the New England Journal of Medicine that in some instances ISP contracts can expand access, by lowering the price of drugs for some indications. However, ISP contracts could also increase prices for high-value indications. Drugs for a certain indication that were once accessible may turn out not to be.

    Innovative contracting/pricing approaches like OBPCs, VBPs, and ISPs appear to be growing, potentially addressing the public’s desire for action on drug prices. But they’re still new and have not been adequately studied formally to assess if they reduce prices relative to the counterfactual prices that would have existed in their absence.

    Studying them is a challenge because the majority of these contracts exist in the private-market, often away from the eyes of the public. In terms of crafting informed policy, as Kaltenboeck and Bach aptly wrote, “’trust us’ can hardly be considered the foundation for good public policy.”

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  • It’s Time for a New Discussion of Marijuana’s Risks

    The following originally appeared on The Upshot (copyright 2018, The New York Times Company). 

    The benefits and harms of medical marijuana can be debated, but more states are legalizing pot, even for recreational use. A new evaluation of marijuana’s risks is overdue.

    Last year, the National Academies of Sciences, Medicine and Engineering released a comprehensive report on cannabis use. At almost 400 pages long, it reviewed both potential benefits and harms. Let’s focus on the harms.

    Cancer

    The greatest concern with tobacco smoking is cancer, so it’s reasonable to start there with pot smoking. A 2005 systematic review in the International Journal of Cancer pooled the results of six case-control studies. No association was found between smoking marijuana and lung cancer. Another 2015 systematic review pooled nine case-control studies and could find no link to head and neck cancers.

    Another meta-analysis of three case-control studies of testicular cancer found a statistically significant link between heavier pot smoking and one type of testicular cancer. But this evidence was judged to be “limited” because of limitations in the research (all of which was from the 1990s).

    There’s no evidence, or not enough to say, of a link between pot use and esophageal cancer, prostate cancer, cervical cancer, non-Hodgkin’s lymphoma, penile cancer or bladder cancer. There’s also no evidence, or not enough to say, that pot has any effect on sperm or eggs that could increase the risk of cancer in any children of pot smokers. (Using marijuana while pregnant does pose other risks, as discussed below.)

    Heart disease

    Another major risk with cigarettes, heart disease, isn’t clearly seen with pot smoking. Only two studies quantified the risk between marijuana use and heart attacks. One found no relationship at all, and the other found that pot smoking may be a trigger for a heart attack in the hour after smoking. But this finding was based on nine patients, and may not be generalizable.

    Lung function

    It also makes sense to think about the risk of respiratory disease. In the short term after smoking pot, a 2007 systematic review found, lung function actually improved. But these benefits were completely overtaken by evidence that lung function may degrade with chronic use. Lung function, however, is a laboratory measure and not necessarily a clinical outcome, and what we really care about is lung disease. Once you control for tobacco use, the links between marijuana and chronic obstructive pulmonary disease appear minimal. Almost no evidence is available to link pot use to asthma.

    Impaired driving

    Driving while impaired is a major cause of injury and death in the United States. Six systematic reviews were considered of fair or good quality by the national academies, and the most recent one pooled three of the others. It contained evidence from 21 studies in 13 countries representing almost 240,000 participants.

    For people who reported marijuana use, or had THC detected through testing, their odds of being involved in a motor vehicle accident increased by 20 to 30 percent, the study found. This is, of course, a relative increase, and shouldn’t be confused with the overall percentage chance of getting in an accident, which is much smaller.

    Regardless, driving while impaired is a terrible idea. Although we have good tests to determine if people are under the influence of alcohol, no such tests are currently available for marijuana, making enforcement more difficult.

    Pregnancy effects

    Babies born to women who smoke pot during pregnancy are more likely to be underweight, delivered premature and admitted to a neonatal intensive care unit, according to a 2016 systematic review. But there were no links seen for changes in birth length, head circumference or congenital malformations. There’s limited evidence for pregnancy complications for mothers, and there’s not enough evidence to comment on much else about babies and their outcomes.

    Memory and concentration

    There’s moderate evidence, from many studies, that learning, memory and attention can be impaired in the 24 hours after marijuana use. There’s limited evidence, however, that this translates into worse outcomes in academic achievement, employment, income or social functioning, or that these effects linger after the pot has “worn off.”

    Mental health

    The possible relationship between marijuana use and mental health is complicated. The most recent meta-analysis found that there’s a significant connection between heavy marijuana use and a diagnosis of psychosis, specifically schizophrenia. This mirrored the findings of previous reviews that sought to cover only high-quality studies. Another systematic review highlighted a potentially small but statistically significant link between marijuana use and the development of bipolar disorder. Heavy users of pot are also more likely to say they have suicidal thoughts.

    What makes this complicated is that it’s hard to establish the arrow of causality. Are people who smoke pot more likely to develop mental health problems? Or are people with mental health problems more likely to smoke pot?

    There’s a similar issue when talking about the relationship between using pot and other substances. Some see marijuana as a “gateway” drug, leading to other substance use or abuse. Others see this as only a correlation in which people who are likely to use or abuse substances are more likely to use pot as well.

    Secondhand smoke

    As states legalize the drug for general use, more cannabis users feel freed from secrecy. They smoke more in public, raising worries about secondhand smoke. A two-year-old study made news recently by arguing that one minute of exposure to pot smoke impaired how vessels responded to blood flow for at least 90 minutes, a greater impairment than from tobacco. This was a study in rats, though, not of humans out in the world. As for risk of a “contact high,” the amount of THC detectable in secondhand smoke is negligible.

    Almost all agree that children should not use pot, but concerns are legitimately raised about whether children might have increased exposure or access after legalization. Although this issue has not been studied widely, it’s possible that pot — the THC and the metabolites from smoke — could have an effect on the developing brains of children. These concerns are more applicable to adolescents who use pot regularly, however, not the accidental ingestion reported in the news once in a while.

    New questions

    Almost all the harms the medical literature focuses on involve smoked cannabis. We know little to nothing about edibles and other means of administration. Nor do we have any consistent manner of measuring the level of exposure.

    Bottom line: Weigh pros and cons

    Many of the harms we’ve discussed are statistically significant, and yet they are of questionable significance. Almost all the increased risks are relative risks. The absolute, or overall, risks are often quite low.

    We haven’t focused on the potential medical benefits here. But many people use pot — even rationally — for benefits they perceive to be greater than the harms we’ve listed.

    We unquestionably need more research, and more evidence of harms may emerge. But it’s important to note that the harms we know about now are practically nil compared with that of many other drugs, and that marijuana’s effects are clearly less harmful than those associated with tobacco or alcohol abuse.

    People who choose to use marijuana — now that it’s easier to do legally — will need to weigh the pros and cons for themselves.

    @aaronecarroll

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  • Disparate Impact and the Administrative Procedure Act

    This post was co-authored with Eli Savit, an attorney and adjunct professor at the University of Michigan Law School.

    In a New York Times op-ed this week, we argued that a Michigan bill that would impose work requirements on Medicaid beneficiaries violates Title VI of the Civil Rights Act of 1964, which prohibits any program receiving federal funds from discriminating on the basis of race. As currently written, the bill exempts people who live in counties with high unemployment from the work requirement, but doesn’t extend the same accommodation to cities with high unemployment. Because Michigan’s black communities are concentrated in cities, the facially neutral exemption will disproportionately benefit white, rural Michiganders over their black, urban counterparts.

    But so what? In its 2001 decision in Alexander v. Sandoval, the Supreme Court held that Title VI doesn’t supply a private right of action to vindicate a disparate impact claim. So if Michigan passes this bill, and the Trump administration declines to enforce Title VI, is there any legal remedy? Suing the Trump administration for declining to take disciplinary action against Michigan won’t work. Under Heckler v. Chaney, HHS’s decision to decline to enforce Title VI is unreviewable.

    We nonetheless think the Michigan bill is vulnerable to legal challenge. The key, in our view, is that Michigan can only impose work requirements if it gets a waiver from HHS under section 1115 of the Social Security Act. And the Second, Third, and Ninth circuits have all held, consistent with the presumption favoring judicial review of agency action, that the decision to grant an 1115 waiver is reviewable under the Administrative Procedure Act. The APA thus supplies the cause of action that Title VI doesn’t.

    It would be arbitrary within the meaning of the APA for HHS to grant a waiver that licenses Michigan to violate HHS’s own rules governing Title VI. At a minimum, HHS would have to offer a reasonable explanation for why, in the face of the exemption’s disparate impact, there’s a “substantial legitimate justification” for what Michigan wants to do. As we argued yesterday, it’s doubtful that HHS could meet that burden, even under a deferential standard of review. The disparate impact is blatant and a substantial justification for it is nonexistent.

    Trying to use the APA as a vehicle to vindicate Title VI isn’t novel. Prior to Sandoval, however, the approach was a nonstarter. The APA makes reviewable “final agency action for which there is no other adequate remedy in a court.” Before Sandoval, courts regularly entertained private disparate-impact claims under Title VI, so there was an “adequate remedy” that precluded APA review. As the D.C. Circuit reasoned in an opinion that ended the long-running educational dispute of Adams v. Richardson, “Congress considered private suits to end discrimination not merely adequate but in fact the proper means for individuals to enforce Title VI and its sister antidiscrimination statutes.”

    Sandoval changed all that by eliminating a private right of action for disparate impact claims. Absent that “special, alternative remedy,” an APA claim to enforce an agency’s compliance with its Title VI regulations should now be viable.

    The post-Sandoval case law on the question is thin, but what little there is reinforces that conclusion. As the Sixth Circuit has observed (albeit outside the Title VI context):

    There is a major difference between a plaintiff attempting to obtain a remedy against a person subject to federal regulations, and a plaintiff attempting to hold an agency accountable for alleged violations of its own rules. Sandoval spoke to the former situation—alleged misconduct by a regulated person. But this case involves the latter situation—review of agency action.

    In line with that reasoning, a California district court ruled last month in an environmental case that “neither a Title VI nor an equal protection claim constitutes an adequate remedy to an APA claim” when it comes to disparate impact. Indeed, the U.S. Justice Department has itself raised that possibility of APA suits to vindicate Title VI, and Justice Breyer made a related point in a concurrence in a case about the enforcement of the Medicaid statute.

    In our view, the APA theory is sound. We’re less sure that the Supreme Court still believes, as it once did, that Title VI authorizes agencies to issue rules that prohibit policies that have a disparate racial impact. If the Court were to rethink that position, an APA challenge to the waiver couldn’t succeed. But who knows? Lower courts can’t indulge in armchair predictions about what the Supreme Court might do. They’re bound unless and until the Supreme Court reverses itself. And, under existing case law, the Michigan bill looks really dubious.

    One final note. Because of persistent income disparities across race, minority groups are overrepresented in the Medicaid population. As a result, any waiver that allows states to constrain Medicaid eligibility will have a disparate racial impact—and, as such, is vulnerable to the argument that HHS granted the waiver in contravention of its own Title VI regulations.

    The argument hasn’t been pressed in the high-profile lawsuit challenging Kentucky’s work requirements, but maybe it should be. Sure, it’s possible that HHS can offer a “substantial legitimate justification” for work requirements—at least one that can survive APA arbitrariness review—notwithstanding their racial disparate impact. But given the fragility of the justifications for work requirements, an APA-cum-Title VI claim has a decent shot at succeeding—at least as good a shot, we think, as the arguments currently being raised.

    @nicholas_bagley & @EliNSavit

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