• Technical points about the rule that ends the substance use disorder data scrubbing

    When SAMHSA issued its proposed rule, I had two concerns about its scope. Writing on AcademyHealth’s behalf, I asked SAMHSA for clarification. Both of my concerns have been addressed in the final rule—one satisfactorily, the other not so much.

    First, a provision on data linkages—efforts to link Medicare and Medicaid data with other datasets—could have been read to say that researchers couldn’t do such linkages on their own, but would have to ask CMS to perform such linkages for them. That would have been bad. As AcademyHealth explained, “CMS is overtaxed, and we are not optimistic that it will be able to expeditiously, inexpensively, and accurately do the complex work associated with linking data across disparate data sets.”

    SAMHSA apparently agreed. In the final rule, it clarified “that the data linkages provision is not intended to prohibit a researcher from linking a data set in the researcher’s possession that contains part 2 data with a data set from a third party source.” In other words: victory!

    Second, the proposed rule didn’t seem to allow records relating to substance use disorders to be shared with data intermediaries, including the all-payer claims databases (APCDs) that now exist in about 18 states. Because APCDs and other intermediaries aren’t providers or payers, they aren’t “lawful holders” of such records within the meaning of the regulations. As such, they can’t collect those records and they can’t share them with researchers.

    SAMHSA recognized the issue and, in its rule, offered what it apparently considered a solution. The agency clarified that APCDs and other data intermediaries “are permitted to obtain [data on substance use disorders] under the research exception, provided that the conditions of the research exception are met.” At that point, APCDs and intermediaries would become “lawful holders” of the data and “would therefore be permitted to redisclose [those] data for research purposes.”

    That sounds good. But if you look at the new rule, it appears that APCDs and other intermediaries can’t take advantage of the research exception. Under the rule, you’re eligible for the exception only if you’re (1) a HIPAA-covered entity or (2) subject to HHS rules governing human subjects research.

    APCDs and other data intermediaries don’t appear to qualify. Because they’re not providers, plans, or payment clearinghouses, they’re not “covered entities” within the meaning of HIPAA. And I don’t see why APCDs or other intermediaries would be subject to the rules governing human subjects research. They’re not federal entities and, to my knowledge, their research isn’t supported by federal funds.

    If that’s right—and it’s possible I’m missing something—then SAMHSA has effectively prohibited APCDs and other data intermediaries from receiving identifiable records pertaining to substance use disorders. The states that were hoping to use their APCDs to help them tackle the opioid epidemic can forget about it.


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  • Ending the substance use disorder data scrubbing

    Three years ago, and without notice, data about patients with substance use disorders began to disappear from Medicare and Medicaid files widely used in health services research. Because researchers had been afforded access to those data for decades, the change was mystifying. Austin raised an alarm, and he and I began to look into it.

    The culprit was a 1976 regulation governing the privacy of information pertaining to substance use disorders. On its face, the regulation—which was drafted well before electronic records came into common use—seemed to prohibit the Centers for Medicare and Medicaid Services (CMS) from sharing such information with researchers. No one apparently noticed until 2013, at which point CMS started scrubbing its data.

    This was a calamity for health services research. The data scrubbing made it impossible to use Medicare and Medicaid records to study efforts to combat addiction and the consequences of substance use. Beyond that, the non-random withholding of data would predictably skew research into any condition that was more common among people with substance use disorders—a point elegantly confirmed by a research team from Brigham & Women’s Hospital in Boston.

    Here at the blog and in the pages of the New England Journal of Medicine and the New York Times, Austin and I exhorted the Substance Abuse and Mental Health Services Agency (SAMHSA) to revisit the 1976 rule. Last February, SAMHSA agreed to do so, issuing a proposed rule to end the data-scrubbing. We crossed our fingers and waited.

    The wait was rewarded on Friday with the release of a final rule that closely tracks the original proposal. Under the rule, CMS is free to share addiction-related records with researchers who secure Institutional Review Board approval and agree to appropriate safeguards—standard procedure for receipt and use of all identifiable CMS research data. In considering the comments that it received, the agency took real pains to enable research into addiction and correlated conditions, pointedly rejecting input that would have imposed needless burdens.

    In short, the rule is excellent. SAMHSA should be commended.

    There’s still a shadow here, however. Because the rule doesn’t take immediate effect, the incoming administration can still withdraw it. And President Trump will almost certainly impose a moratorium on any Obama-era regulations to allow his administration to review them. That doesn’t mean the rule is dead: given the President’s expressed interest in curtailing the opioid epidemic, Austin and I are cautiously optimistic that the rule will eventually go through.

    But nothing is certain. The fight isn’t quite over yet.


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  • Healthcare Triage News: Medicaid for Children Leads to Better Outcomes Later in Life

    The recent election has caused many to question whether significant changes are about to happen to Medicaid. Repeal of the Affordable Care Act would, of course, lead to the elimination of the Medicaid expansion, which could result in significant numbers of adults losing their coverage overnight.

    But even without repeal, many Republican replacement proposals also result in significant changes to Medicaid, whether it be through funding, eligibility, or benefits. So, again, let’s talk about what Medicaid does, and whether it’s long term benefits are worth it. This is Healthcare Triage News.

    This episode was adapted from a post I wrote for the AcademyHealth blog. Links to further reading and sources can be found there.


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  • AcademyHealth: Private vs. public prices

    The prices private health insurers pay hospitals have long been above those paid by Medicare and Medicaid. But in recent years, the difference between public and private prices has grown tremendously. Why? Read my latest AcademyHealth post for more.



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  • Healthcare Triage: Donald Trump and Healthcare Cost Sharing

    One of the few things that both Donald trump and Hilary Clinton seemed to agree on is that high out-of-pocket spending, specifically as it relates to the Affordable Care Act, is a problem. One of Clinton’s most popular health care proposals during her campaign was to reduce out of pocket spending to more “manageable” levels for many Americans. President-elect Trump sought to fix this problem by repealing the ACA and replacing it with something better.

    Reducing out-of-pocket spending, however, will require some tradeoffs. No easy solution exists, but there are examples out there worthy of consideration. That’s the topic of this week’s Healthcare Triage.

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


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  • Trump’s “executive orders” are a communications strategy.

    According to Vice-President-elect Pence, “We’re working now on a series of executive orders that will enable that orderly transition to take place even as Congress appropriately debates alternatives to and replacements for ObamaCare.”

    This talk about using executive orders to assure an “orderly transition” is a bit confusing. An E.O. has legal force “only if the presidential action is based on power vested in the President by the U.S. Constitution or delegated to the President by Congress.” Authority to implement the ACA, however, is vested in the Secretaries of HHS, Treasury, and Labor—not the President. In the context of the ACA, an executive order won’t be anything more than a document containing a president’s instructions to his subordinates.

    That’s why, as Tim Jost details here, President Trump can’t use E.O.s to change the rules that have been adopted to implement the ACA. To do that, agency officials would have to undergo cumbersome rulemaking processes. Guidance documents are easier to withdraw and amend, but an E.O. probably can’t do the job (although strong proponents of the unilateral executive might argue otherwise). Instead, the E.O. would instruct Secretary Price or Secretary Mnuchin to withdraw or amend the guidance that their predecessors adopted.

    So if the E.O.s won’t have legal significance, what’s going on? One possibility is confusion. When he says “executive orders,” maybe Pence really means “executive actions,” by which he means actions taken by executive branch officials. Maybe we won’t see any real “executive orders” at all.

    But I don’t think that gives the incoming administration enough credit. It’s true that President Trump doesn’t need an E.O. to tell Secretary Price to reconsider the rules governing contraception coverage or essential health benefits. He can issue instructions in all sorts of other ways: in meetings, memos, press conferences, telephone calls, or even tweets.

    Yet executive orders have three distinctive features that make them attractive to the incoming president. First, they are public, which enables Trump to signal that he’s following through on his campaign promises and that he wishes to be judged on that. He can then take political ownership of what his agencies do, for better or for worse. (Then-Professor Elena Kagan elaborated on this point in Presidential Administration.)

    Second, executive orders are formal, allowing the President to communicate to stakeholders and the public his seriousness of purpose and resolve. Presidents juggle lots of different priorities, and it’s often hard to know which initiatives are a genuine focus of presidential attention. Trump can use executive orders to suggest that he’s throwing the full weigh of his office behind his efforts to undo and remake the ACA.

    Finally, and most interestingly, the vigorous (and often misplaced) controversy over executive orders during the Bush and Obama administrations has lent such orders a patina of presidential unilateralism and disregard for law. At the same time, it’s become an article of faith among Republicans that Obama systematically abused his powers in implementing the ACA. Promising to issue executive orders thus allows Trump to signal that he’s not afraid of committing the same sorts of abuses to undo Obama’s. It’s a way of cultivating his image. To his base, he’s saying, “I may be a son of a bitch, but I’m your son of a bitch.”

    In other words, executive orders can be central to Trump’s communications strategy even if they lack legal significance. Still, that’s all they are: a communications strategy.


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  • What care for our pets tells us about health care for ourselves

    The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

    In almost every year since the 1960s, health care spending has grown at least as fast as the overall economy, and often much faster. Health economists have long debated why.

    Strange as it may sound, how we care for our pets offers some answers.

    The pet care markets look a little like the market for human health care. Health spending by American households has grown 50 percent between 1996 and 2012. Pet care spending has grown by a similar amount, 60 percent, though from a much smaller base. (Americans spent more than $15 billion on pet health care in 2015, but $3.2 trillion on human health care.)

    An estimated 68 percent of households have pets; those families with higher incomes spend more, which is also true of human care. And they spend more toward the end of humans’ and pets’ lives alike.

    The supply of both physicians and of veterinarians has grown at a more rapid rate than overall employment. Since 1996, the number of physicians has grown by about 40 percent. The number of veterinarians is up 100 percent.

    “These commonalities made us think that something else may be behind the rapid growth in human health care spending,” said Amy Finkelstein, an M.I.T. economist and one of the authors of a recent study on pet care.

    She, along with her co-authors Liran Einav and Atul Gupta of Stanford, tried to find what that something else could be in their study on pet health care presented at the American Economic Association annual meeting in Chicago. “We often blame generous insurance and significant public sector involvement, but those are absent from pet care,” Ms. Finkelstein said.

    Some health economists say generous health insurance and significant government intervention in the health care market promote unnecessary spending. They note the United States spends more of its G.D.P. on health care than other similar advanced economies yet does not exhibit broadly better health outcomes, a sign of inefficiency. But other economists argue that health care is so valuable that we might reasonably spend even more on it than we do today.

    Which camp is right?

    The three economists pointed out that, in contrast with the market for human health care, there is much less government involvement in pet care.

    Pet health insurance is also much less common. More than 90 percent of Americans now have health insurance, an industry that has been with us since before World War II. But only 1 percent of dogs and cats are insured for pet care, a relatively new product. (According to the North American Pet Health Insurance Association, the first pet health insurance policy in the United States was written for Lassie, the TV dog star, in 1982.)

    So the economists’ focus turned to the commonalities. Human and pet health care are both provided by experts — doctors and veterinarians — who’ve undergone lengthy and expensive training and occupational licensing. That expertise commands high salaries. It also gives them the authority to recommend treatments and tests, the need for which most consumers cannot independently judge.

    You trust your vet as you would trust your doctor to do what is best, especially when an emotional decision is being made. Both human and pet health care are accompanied by strong emotions, making it hard to rationally weigh the value of options. Moreover, the need for care, whether it is for a pet or a human, is difficult to predict and often urgent, again threatening our ability and willingness to shop for the best deals.

    Technology plays a role, too. Complex procedures, new pharmaceuticals and high-tech imaging, which drive human health care spending, are no longer uncommon in pet care, increasing those costs.

    Though routine veterinary visits might cost pet owners only a couple of hundred dollars per year, a serious condition can be very expensive. A dog’s kidney transplant can run $25,000, and a cat’s cancer treatment can cost $10,000 or more. Even if such high costs are extremely rare, it is not as uncommon for a pet owner to encounter a $2,000 to $4,000 bill at some point, particularly near the end of a pet’s life.

    “It makes you think that the emotional nature of the treatment decision may be important in explaining high and sometimes heroic end-of-life health care spending,” Ms. Finkelstein said, “whether on your dog or on your mother.”

    If emotions are in fact driving the higher spending, will it hasten the trend toward more pet insurance? The pet health insurance industry is growing, with total premium volume up about 17 percent in each of the last two years. It’s one of the fastest-growing employee benefits; Delta Air Lines, Hewlett-Packard, Microsoft, U.P.S. and Xerox now offer it.

    The most common policies cover care for injuries due to accidents, as well as care for illnesses like arthritis or cancer, with monthly premiums starting around $22 for dogs and $16 for cats. But premiums can be higher depending on breed, age and where you live. Some other policies also cover preventive care, like vaccinations.

    In general, plans won’t cover pre-existing conditions, pregnancy and birth-related costs, or animals less than a couple of months old. Typically owners pay 20 percent of treatment costs, with plans picking up 80 percent, though some insurers offer other cost-sharing options.

    Is pet insurance a good deal? Consumer Reports explored its value last year and concluded it’s typically not worth the price. Only if your pet has very high care costs will insurance pay out more than you would pay in premiums. According to analysis by Ms. Finkelstein and her Stanford colleagues, nearly two-thirds of all pet care costs is spent by just 20 percent of households with pets. This guarantees that most policyholders won’t get back what they pay in. This is true of human health insurance, too, and for the same reason.

    But the point of health insurance — whether for humans or their pets — is to protect against the risk of catastrophically high costs, not to make money.

    Consumer Reports suggests an alternative when it comes to pet care: self-insuring. Many pet owners could probably build up several thousand dollars in an emergency fund that could be used to help cushion the blow of unusually high pet care costs. Saving enough to weather a serious, human medical condition that could cost tens of thousands of dollars year after year or more is not something most Americans could do.

    Though you might reasonably avoid pet care insurance, you really can’t do that with human health insurance. Human and pet health care may have some commonalities, but this isn’t one of them.

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  • Screwing Congress

    There’s been a lot of talk about the executive actions that President Trump might take to reshape the Affordable Care Act. Here’s one I haven’t heard discussed: undoing the Hill fix.

    Prior to the ACA, members of Congress and their staffers got health coverage through their jobs, just like most Americans. But Congress wanted to signal that it believed in the new exchanges that the ACA created. The ACA therefore sent members and their staffers onto the exchanges. Specifically, the ACA says that “the only health plans that the Federal Government may make available to Members of Congress and congressional staff … shall be health plans that are … offered through an Exchange.”

    That left an open question. Could the federal government continue to pay for members’ and staffers’ health plans? Or would they have to pay for their plans out of their wages?

    The statute wasn’t entirely clear, so the Office of Personnel Management weighed in. It concluded that the ACA allowed the federal government, as an employer, to purchase exchange plans for members and staffers. That was good news for people who work on the Hill: zeroing out their health coverage would have amounted to an enormous pay cut.

    But the ACA’s opponents were incensed. Within months, Senator Johnson filed a high-profile lawsuit challenging the rule as unlawful. (It was later dismissed on standing grounds.) Senator Cruz wrote that “[t]he Obama Administration ignored clear federal statutes in erroneously deciding that the federal government would continue subsidizing congressional staff health insurance.” And the Wall Street Journal excoriated the Obama administration for its “illegal” action.

    As I explained at the time, the opponents’ legal arguments aren’t convincing. But I’ve also said that the ACA “is ambiguous on the precise question at hand.” That ambiguity gives Trump an opening. The Obama administration interpreted the ACA to favor members and staffers. Trump could re-interpret it to screw them.

    And boy oh boy would he screw them. In 2014, as Charles Gaba pointed out, some 12,359 members of Congress, staffers, and their dependents got coverage through the D.C. exchange. Those who earn too much to be eligible for subsidies—including the members themselves—will have to buy full-price coverage. For a silver plan in 2016, that’ll run a 55-year-old about $5,100 per year. Premium subsidies will help lower-income staffers, but they’ll still take a big pay cut and they don’t make much to begin with. We’d probably see a mass exodus of congressional staff.

    So what will Trump do? Since Republicans are convinced that the Hill fix was an illegal power grab, maybe he’ll do ‘em a solid and change the rule. They’ll need Trump’s help since they probably can’t undo the Hill fix through reconciliation. Sure, amending the rule would hurt. But, judging from their replacement plans, Republicans think it’s good politics to take health insurance from people. Maybe members and staffers will thank Trump!

    It’s much more likely, however, that they’d resent the pay cut, just like anyone would. That’s why I don’t see Trump picking this particular fight. The vitriol around the legality of the Hill fix—and around Obama implementation in general—has been more about partisan politics than about the law. Now that the president is on Congress’s side, I expect Republicans will conveniently forget about this ostensibly illegal rule that wasn’t illegal in the first place.

    Which is fine by me. But it’s worth noticing that, in the debate over ACA implementation, legal arguments became a continuation of politics by other means (to borrow from Clausewitz). We’re sure to see the same sort of thing from Democrats once Trump is sworn in. In the zero-sum war that characterizes American politics today, both parties will take every advantage they can.

    But weaponizing the law is dangerous. Law isn’t just an extension of politics. Some legal questions have answers, and those answers shouldn’t change with shifting political winds. If they do, what special claim can law make to constrain executive behavior?

    I digress, however. Mr. Trump, the Hill fix was never illegal. But the ACA gives you the flexibility to undo it. You’ll be president in ten days. Your move.


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  • Healthcare Triage News: Americans Spend a Lot on Diabetes, Heart Disease, and Back Pain

    One of my fist big efforts on my blog was a ten point series on health care spending in the US. It also led to John doing this video – which is the fourth most popular vlogbrothers video EVER,  – which pretty much led to Healthcare Triage. It’s not surprising, therefore, that I have an ongoing interest in spending on health.

    recent publication in JAMA got into the weeds of where that money has gone. This is Healthcare Triage News.


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  • JAMA Forum: Hospitals don’t shift costs from Medicaid to private insurers

    The Affordable Care Act (ACA) has allowed states to expand Medicaid. Medicaid pays hospitals prices that are lower than those paid by private insurers. Does this cause hospitals to charge private insurers even more to make up the difference, a cost shift?

    Nope. Read the details in my JAMA Forum post.


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