Health Care

October 15, 2020 1:32PM

Opioid Policymakers Keep Tilting at Windmills, Striking Patients in the Process

The American Psychological Association Dictionary of Psychology defines “denial” as “a defense mechanism in which unpleasant thoughts, feelings, wishes, or events are ignored or excluded from conscious awareness. It may take such forms as refusal to acknowledge the reality of a terminal illness, a financial problem, an addiction, or a partner’s infidelity…”

Many policymakers, including many in Congress, remain in a state of denial about the true cause of the overdose crisis: drug prohibition.

The Centers for Disease Control and Prevention’s October 4, 2020 provisional report on overdose deaths for the 12‐​month period ending March 2020 shows a total overdose death rate of 73,860 (up from 67,726 a year earlier), of which 52,488 are opioid‐​related. 39,535 (75 percent) of the opioid‐​related deaths involved illicit fentanyl and 13,793 (26 percent) involved heroin. Prescription‐​type opioids were found among 12,002 of opioid‐​related deaths (23 percent). Methamphetamine and psycho‐​stimulants were found in 17,435 (33 percent), and cocaine was found in 16,970 (32 percent) of total overdose deaths, also up dramatically over the past year.

Despite these glaring numbers, Senator Elizabeth Warren (D-MA) and Representative Katherine Clark (D-MA) joined with other House and Senate colleagues in sending a letter to the Drug Enforcement Administration urging the agency to finalize new regulations that would allow pharmacists to partially fill opioid prescriptions if they judge that patients don’t require the entire amount of opioids prescribed.

As Josh Bloom of the American Council on Science and Health points out:

On the surface, it would seem that the new regulation would be harmless, possibly even helpful. For example, it would enable someone with a prescription for 20 Vicodin tablets to tell the pharmacist “Gee, I don’t really need 20, just give me 15.” (As if that’s ever going to happen in this universe.) What is far more likely is for the pharmacist to say “you only need 15, not 20″ which isn’t the least bit difficult to believe since pharmacists have been haphazardly imposing their own limitations prescriptions for years :

“As a patient advocate and healthcare writer who is very active in social media, I see reports from thousands of patients who have been denied a refill of valid prescriptions for opioid pain medications. This is particularly true for prescriptions at high doses. And it is a trend reinforced by insurance providers and pharmacy chains as policy without scientific support. It’s pretty obvious that Elizabeth Warren and her colleagues literally don’t know what they are talking about.”—Richard “Red” Lawhern, Ph.D., Co‐​founder of the Alliance for the Treatment of Intractable Pain, and a member of the ACSH Scientific Advisory Board

The supposed rationale is to reduce the number of unused prescription opioids that can get stolen or otherwise diverted into the black market for non‐​medical use.

But the DEA and other policymakers have effectuated a dramatic reduction in opioid prescribing only to see the overdose rate climb, as non‐​medical users have switched over to cheaper and more readily available heroin and fentanyl provided by the efficient black market. Furthermore, there is no correlation between prescription volume and non‐​medical use or addiction among persons age twelve and up.

As millions of patients get abruptly tapered off of their chronic pain medications, and millions of others go under‐​treated for acute pain, policymakers remain in a state of denial and continue to press a quixotic war on prescription opioids in which patients in pain are civilian casualties.

October 14, 2020 3:33PM

King v. Burwell: A Clear Example of Legislating from the Bench

Confirmation hearings for Supreme Court nominee Judge Amy Coney Barrett have renewed interest in the 2015 case King v. Burwell. In 2017, Barrett told NPR that between Chief Justice John Roberts’ majority opinion and Associate Justice Antonin Scalia’s dissent, “The dissent has the better of the legal argument.” Democrats thus fear Barrett will not treat ObamaCare with due reverence when a new constitutional challenge reaches the Court on November 10.

The U.S. Supreme Court - Photo Credit: Claire Anderson

It was unintentionally fitting when, on the third day of hearings, Sen. Amy Klobuchar (D-MN) quoted a 2017 law review article Barrett authored:

There is a risk that a faction can run away with the legislative process, but there is also a risk that a faction will conscript courts into helping them win battles they have already lost, fair and square.

Klobuchar claimed the quote describes the upcoming ObamaCare challenge. But it is a better description of King, in which the Obama administration and its supporters pressured six Supreme Court justices to grant them a policy victory they lost fair and square in the political arena.

King concerned whether the ACA authorizes the executive to subsidize health insurance premiums and enforce the individual and employer mandates in states that do not establish a health insurance Exchange. The ACA clearly and consistently authorizes such subsidies (nominally, tax credits), and the mandate penalties they trigger, if a taxpayer enrolls in a qualified health plan “through an Exchange established by the State.” The law directs the federal government to establish Exchanges in states that do not establish one themselves. But nowhere does it authorize subsidies in federally established Exchanges. In effect, the ACA thus empowers states to block the subsidies, the employer mandate, and in many cases the individual mandate simply by not establishing an Exchange.

Not only is that what the ACA says–which is the real test of congressional intent–but all available contemporaneous evidence also shows that is in fact what congressional Democrats understood the law would do. It isn’t even a close call. Even the Obama administration’s most ardent defender acknowledged the ACA “clearly say[s]” subsidies are available only in states that establish an Exchange. During litigation, the Obama administration and congressional Democrats admitted that Senate Democrats wanted to withhold premium subsidies in states that failed to implement the federal regulatory scheme. House Democrats literally complained that the ACA would give states so much power to block its subsidies that “millions of people will be left no better off than before Congress acted.” NPR reported many House Democrats from Texas “worry that because leaders in their state oppose the health bill, they won’t bother to create an exchange, leaving uninsured state residents with no way to benefit from the new law.” What Jonathan Adler and I wrote in 2015 remains true: “to this day, neither the government, nor the Supreme Court, nor anyone else has identified even a single contemporaneous statement of any kind asserting that the ACA authorizes, or that its supporters intended for it to authorize, tax credits in federal exchanges.” Not a single ACA supporter claimed anything different until after critics began to take notice of the powers that this feature gave states to block the law.

If the ACA were not a high‐​stakes, highly controversial law—if it were not the culmination of decades of left‐​of‐​center political activism, or a president’s signature accomplishment, or the event that supposedly gave the United States membership in the club of civilized nations—career executive branch officials would have just implemented the statute as written, and left it to Congress to make any necessary changes.

Yet after Democrats took a “shellacking“ in the 2010 elections—public opposition to the ACA gave Republicans control of the U.S. House of Representatives and three‐​fifths of state legislative chambers, which ultimately led to some 38 states not establishing Exchanges—the Obama administration feared that this feature would give the American people a little too much input into the ACA’s survival. It subsequently announced it would dispense those subsidies and impose those penalties in every state, regardless of what the ACA clearly says.

That decision subjected tens of millions of Americans to taxes from which Congress expressly exempted them, and led multiple states, employers, and individuals to file four separate legal challenges. Plaintiffs in these cases secured victories at both the district‐ and appellate‐​court levels. A circuit split led the Supreme Court to grant certiorari.

On June 25, 2015, after the Obama administration and its allies spent months working the ref, six Supreme Court justices let the administration get away with it. Chief Justice Roberts acknowledged that “the most natural reading of the pertinent statutory phrase” is that the administration could implement the disputed taxes and subsidies only in states that establish Exchanges. He acknowledged his ruling flatly contradicted the words Congress used to speak directly to the question before the Court. Yet he and five justices blessed the administration’s extra‐​statutory (and therefore unconstitutional) taxes and spending. Jonathan Adler and I wrote this detailed critique of Roberts’ opinion. Here’s a summary I wrote later in 2015:

In King v. Burwell, six Supreme Court justices commanded the IRS to do what all nine justices agreed is the opposite of what Congress wrote into law…Specifically, the King majority commanded the IRS to subject some 70 million Americans to taxes from which Congress expressly exempted them, and to dispense tens of billions of dollars that all nine justices agreed Congress expressly forbade the agency to spend. Finally, the King majority disempowered states by depriving them of the power to block those taxes and subsidies—a power that all nine justices agreed Congress granted them—and disenfranchised millions of voters who elected the state officials who exercised those powers…

The six‐​justice majority, and the three dissenting justices explicitly agreed on the following points:

  • The ACA plainly authorizes premium‐​assistance tax credits (hereafter, premium subsidies) only, as the operative text says, “through an Exchange established by the State”;
  • Congress expressly defined “State” in a manner “that does not include the Federal Government”; and
  • When the Obama administration chose nevertheless to offer premium subsidies in the 38 states with Exchanges established by the federal government, it had the effect of expanding the reach of the ACA’s individual and employer mandates to millions of Americans…whom “the most natural reading” of the operative text exempted from those taxes.

Moreover, all nine justices implicitly agreed there is no indication Congress intended anything other than what the operative text says.

King enabled an even greater power grab than the Court knew. The ACA conditions the taxes and subsidies in question not only on states establishing Exchanges, but also on states implementing a reinsurance program, a risk‐​adjustment program, and other elements of the Act’s regulatory scheme. Not a single state even tried to implement all of those aspects of the law–which means the federal government has no statutory authority to implement those taxes and subsidies in any state. As I wrote in 2015:

Had the justices simply upheld the ACA as Congress wrote it, they would have immediately freed 70 million Americans in 34 states from unauthorized taxes, and enabled 30 million Americans in the remaining 16 states (California, New York, etc.) to sue for similar relief — if Congress didn’t provide relief first, which is both likely and how democracy is supposed to work. Instead, the Court allowed the IRS to continue implementing a nationwide system of taxes and entitlements in direct conflict with the words Congress chose to govern the question presented.

To reach the policy outcome it desired, the King Court abandoned the usual rules. Yale law professor Abbe Gluck explains the Court “adopted essentially the opposite” approach from what it had in previous statutory‐​interpretation cases. As attorney Dan McLaughlin observes:

In 2018, the Court, when presented with almost exactly the same issue in a less‐​controversial area of the law, unanimously refused to even so much as cite King as a precedent (even when lower courts in the case had followed it), and reached a directly opposite conclusion.

McLaughlin further notes that the five remaining justices in the King majority abandoned their own reasoning again in a case the Court decided in 2020. The King five all signed on to the following language, which flatly contradicts their reasoning in King:

Those who adopted the [statute] might not have anticipated their work would lead to this particular result. Likely, they weren’t thinking about many of the Act’s consequences that have become apparent over the years…But the limits of the drafters’ imagination supply no reason to ignore the law’s demands. When the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest. Only the written word is the law, and all persons are entitled to its benefit.

“In other words,” McLaughlin concludes, “none of the justices who signed onto the King decision actually believed in it.”

Supporters like to say that King upheld the ACA. On the contrary, King tossed out the ACA in favor of something that ACA supporters wish they could have gotten through Congress but couldn’t. It is one of countless unconstitutional executive and judicial revisions that have transformed the statute Congress passed into a law no Congress ever enacted or could have enacted. To defend King v. Burwell is to abandon the ACA in favor of “ObamaCare.”

Thus King v. Burwell is a ruling at war with the idea of law itself. It is a real‐​life example of elites rejecting the idea that the consent of the people should constrain their ability to wield power over the people. It allowed the executive and judicial branches to impose taxes and disburse subsidies that no Congress ever authorized—or could have authorized. It disrespects not only the ACA, but the Constitution, every level of our democracy, the American people, and the idea of law itself. No judicial nominee should ever defend or hesitate to criticize it.

October 12, 2020 5:31PM

COVID-19 Vaccines Depend on Globalization (And, Therefore, So Does the Trump Administration)

Last week, the Wall Street Journal examined government efforts to secure early access to doses of the most advanced COVID-19 vaccines, and how this access could prove to be a game‐​changer for these economies in 2021. As shown in the following WSJ chart, many governments have contracted with multiple pharmaceutical companies in order to ensure that they have access to at least one vaccine that successfully completes “Phase III” trials, which are now underway for most of the listed drugs. Among these governments is the United States, which has thus far secured vaccine commitments from Oxford/​AstraZeneca (0.91 doses per capita); Novavax (0.3); Sanofi/​GSK (0.3); BioNTech/​Pfizer (1.83); J&J/Janssen (0.3); and Moderna/​NIAID (1.52). This puts the United States second, behind only the United Kingdom, in contracting for early vaccine doses and thereby potentially saving thousands of American lives and restarting the struggling domestic economy if one or more of those vaccines pans out.

Governments have contracted with several drugmakers to secure early access to COVID-19 vaccines

Beyond the sheer size and scope of the U.S. effort, what’s perhaps most striking here is the extent to which the Trump administration jettisoned its economic nationalism in pursuit of a game‐​changing COVID-19 vaccine. Indeed, as shown in the chart below (based our own independent research), each of the vaccines that the United States has secured appears to be heavily reliant on globalization — of investment, manufacturing, testing, and research personnel — to produce the final doses at the absolute maximum speed and scale.

This summary, moreover, is only the tip of the iceberg when it comes to the truly‐​global effort to beat COVID-19. Unmentioned in the chart above, for example, are all of the other people from around the world — investors, researchers, production workers, etc. — that make the listed companies, facilities and processes hum, as well as the previous global collaborations that have driven pharmaceutical innovation for decades.

Also unmentioned are the numerous other vaccine candidates that are in earlier stages of development. For example, a recent survey by the Coalition for Epidemic Preparedness Innovations (CEPI), which is working with the World Health Organization to ensure global access to a COVID-19 vaccine, showed over a hundred potential manufacturers of both vaccine‐​related drug substances (inputs) and drug products (doses) located in dozens of countries around the world (including, of course, the United States):

Numerous countries can produce inputs for COVID-19 vaccines
Global COVID-19 vaccine production

Since the unfortunate onset of COVID-19, American politicians of all stripes — but especially in the Trump administration — have blamed “globalization” for the pandemic and promised to re‐​shore U.S. manufacturing to bolster American “resiliency” and national security. Yet these very same officials have quietly embraced that very same globalization when it matters the most.

Lessons abound.

September 29, 2020 11:30AM

Five Problems with Democrats’ “Preexisting Conditions” Strategy

Democrats think preexisting conditions will once again carry them to electoral victory. Despite their own liabilities and callousness on the issue, they’re probably right.

In 2018, Democrats accused Republicans of wanting to deny health care to the sick. Exhibit A, they said, was the GOP’s attempt to repeal ObamaCare’s popular preexisting-conditions provisions. The accusation worked. Democrats flipped a net 41 House seats to take control of the chamber. Conventional wisdom considers the outcome to be proof that ObamaCare is (finally) popular with voters.

In 2020, Democrats are deploying the same strategy. A meritless yet somewhat successful Republican-led legal challenge to ObamaCare now sits before the Supreme Court. Oral arguments will occur mere days after the election and mere days after the GOP replaces the late Justice Ruth Bader Ginsburg with a jurist who is unlikely to approach ObamaCare with the same reverence Ginsburg did: 7th Circuit Court of Appeals Judge Amy Coney Barrett. This confluence of events again enables Democrats to accuse Republicans of wanting to deny care to the sick by eliminating ObamaCare’s popular preexisting-conditions provisions.

There are several problems with this line of attack, however.

  1. Congressional Republicans didn’t try to repeal ObamaCare’s preexisting-conditions provisions.

I wish they had. But even the Congressional Budget Office acknowledged the “repeal” bill House Republicans introduced in 2017 would not have repealed those provisions:

Insurers would still be required to provide coverage to any applicant, would not be able to vary premiums to reflect enrollees’ health status or to limit coverage of preexisting medical conditions, and would be limited in how premiums could vary by age.

Nor would the Senate bill have done so. Senate Republicans could have repealed those provisions with just 51 votes, but they never even tried. The closest thing they came to repealing them was Sen. Ted Cruz’s (R-TX) “freedom option,” which would have made those provisions optional. But Senate Republican leaders gutted that proposal, ensuring their bill would preserve those provisions.

Read the rest of this post »
September 28, 2020 4:05PM

Using Artificial Classes To Settle Mass Litigation: What Ginsburg Knew

Last week the Sixth Circuit rejected a federal judge’s novel certification of an unusual “negotiating class” aimed at promoting a global settlement between opiate manufacturers and cities and counties around the country that have sued them. The designated class would have included thousands of cities and counties around the country that have not filed suit, and the way in which it would have handled their legal interests was assailed from many directions as lacking in fairness. Last week’s ruling triumphantly vindicates the prescience of the late Justice Ruth Bader Ginsburg, the modern Court’s most influential proceduralist voice, whose opinion for the Court in Amchem Products v. Windsor (1997) laid out the path correctly followed by the Sixth Circuit majority. (Judge Eric Clay wrote the opinion, joined by Judge David McKeague; Judge Karen Moore dissented.)

From my point of view, the opiates litigation demanding recoupment of public funds spent on addiction should never have been filed at all, and its proper settlement value would be $0.00. (More herehere, here, etc.) It’s not clear the courts will rule that way, however, and many legal observers expect that, as with many mass tort actions, this one will eventuate in a settlement. Such a settlement would extract money from drug company investors (as well as bystanders such as pain patients who may pay more for medication in future) and redistribute it to mayors, county executives, and their lawyers (many of the latter on contingency fee). As advocates of the “negotiating class” idea saw it, a settlement would be speedier and more generous to the extent that it could be more comprehensive and final. Federal judge Dan Polster in Cleveland agreed (more), and the appeal in In Re: National Prescription Opiate Litigation followed.

Not dissimilar arguments fueled the would‐​be global asbestos settlement brought before the Court in Amchem. There, too, a judge had been talked into what has been called a managerial approach to mass litigation, one that would convert court process into a sort of administered compensation scheme, like black lung, disability, or others commonly situated in the executive branch, while according short shrift to the individual procedural interests of some parties not (yet) suing.

The practical arguments for global disposition back then, as Ginsburg was the first to acknowledge, were weighty. Asbestos litigation was and remains enormously expensive, slow, and chancy, the reverse in all respects of how a beneficent thinker would design a compensation program. But the answer was not to cut corners in the process rights enjoyed by even the humblest federal court litigant by herding all into class outcomes without full and proper individual notice and chance to decide. Federal court procedure holds out a promise of individual hearing and individual adjudication that must not be lost in the felt practical need to aggregate litigant groups and move them by the hundreds and thousands as if on a game board.

Ginsburg and the Court were right then, and the Sixth Circuit panel is right now.

September 23, 2020 3:05PM

Federal Spending and Deficits

Spending and deficits used to be a battleground in federal elections as each party suggested reforms and blamed the other for fiscal irresponsibility. Candidates proposed tax and spending plans, and reporters examined whether the figures added up and what the impact might be.

These days, the leaders of both parties are ignoring the fiscal hurricane heading for landfall on our economy, while reporters rarely probe the politicians about the coming storm.

The Congressional Budget Office has released its latest outlook showing where the budget and economy may be headed. Without reforms, debt held by the public is projected to rise from 98 percent of GDP today to 195 percent by 2050. If Congress expands programs or the nation gets hit with new crises, debt will rise even faster. Americans in the future will face their own costly health, military, and other challenges, and they will have to bear those new costs plus the costs of our excess spending imposed on them through debt.

In its usual understated way, the CBO summarizes the threat:

High and rising federal debt makes the economy more vulnerable to rising interest rates and, depending on how that debt is financed, rising inflation. The growing debt burden also raises borrowing costs, slowing the growth of the economy and national income, and it increases the risk of a fiscal crisis or a gradual decline in the value of Treasury securities.

Here are some charts from the CBO study:

The first chart shows that federal debt spiked in the past from wars and other crises, and that debt will soar to record levels in the future even under CBO’s smooth‐​sailing economic projections.

a

Washington has a spending problem, not a revenue problem. The next chart shows that, without law changes, tax revenues will remain a fairly stable share of the economy, while spending rises rapidly because large federal programs are on an auto‐​pilot growth path.

CBO spending and revenue projections

This next chart shows the growth of federal spending categories under CBO assumptions. The downward slope of the “discretionary” and “other mandatory” lines may be optimistic because Congress occasionally spikes spending on those categories and each of the programs within the categories have lobby groups pushing for more.

c

Tax revenues are expected to edge upward in coming years even without legislated increases. The next chart shows that real bracket creep and expiring tax breaks will boost the federal tax share of the economy.

d

The last chart shows the largest cost driver in the federal budget—health care. One of the presidential candidates plans to expand government health care, yet both parties have failed to tackle the ballooning costs of the health programs we already have.

e

How should we tackle the budget crisis? Downsizing Government proposes many spending cuts.

September 22, 2020 5:50PM

Remove Barriers that Prevent Nurses from Addressing Public and Private Health Crises

Nurses have been on the front line of the COVID-19 pandemic as they have been for every public health crisis from the Spanish influenza to the AIDS epidemic. Yet state governments have made it harder for nurses to help victims of this and other diseases.

In 2004, California enacted a law that restricts the ability of hospitals to assign nurses to where patients need them, which increases the cost of care. In that year, California became the first state to mandate inpatient facilities adhere to predetermined nurse‐​to‐​patient ratios. The law restricts the number of patients each nurse can care for in the hospital. The idea is that more nurses equals better care and increased safety.

Nurses unions have a financial incentive to support such laws because they require hospitals to hire more nurses, which creates more jobs for nurses and increases revenues for nurses unions, just as hospitals oppose them because they cost hospitals money. Even so, Kaiser Health News reports, “nursing and hospital advocates say there is scant research on what the ideal ratios should be, and there are conflicting studies about whether mandating a ratio by law ultimately improves patients’ health.”

The “right” nurse‐​to‐​patient ratio depends on the needs of individual patients, the skills of each particular nurse, and the ever‐​changing technologies available to monitor hospital patients. Letting politicians make those decisions assumes they have better information and incentives than hospitals and nurses themselves. It will inevitably harm consumers by making health care less affordable and accessible, and hamper the health sector’s ability to respond to public health crises, such as by increasing the cost of investing in new hospital capacity.

In response to the COVID-19 outbreak, New York Gov. Andrew Cuomo suspended regulations that make it harder for qualified nurses to practice in the state in an effort to encourage as many nurses as possible to care for the state’s COVID-19 patients.

Yet Cuomo himself has enacted such restrictions. In 2017, he signed a law that made New York the first and only state to require all new registered nurses (RNs) to obtain four years of nursing education instead of just two years. All newly licensed RNs must obtain a bachelor of science in nursing (BSN) degree within 10 years if they want to keep practicing in the state.

As with nurse‐​to‐​patient ratios, the “right” number of years of nursing education varies depending on the particular job a nurse performs. Not every RN job requires a four‐​year degree. There is likewise no reason to think politicians have better information or incentives when it comes to setting these standards than do nursing schools and employers.

Like California’s nurse‐​to‐​patient ratio law, New York’s “BSN‐​in‐​10” law will unnecessarily restrict access to care. It will raise the cost of acquiring and retaining a nursing license, reduce the supply of nurses, increase the price of nursing services, and make health care less affordable and accessible—again, hampering the health sector’s ability to respond to future public health crises.

The COVID-19 pandemic has highlighted how regulation of health care professionals impairs the health care sector’s ability to adapt to public health emergencies. Policymakers should forswear such restrictions on the nursing workforce both now, and after the pandemic ends.

The author thanks Jacqueline M. Pohida, BSN, for her research assistance.