Health Care

January 14, 2021 9:54AM

Arizona, First in Occupational Licensing Reform, Now Poised to Become First in Telehealth Reform

Absorbing lessons learned from the COVID-19 pandemic, Arizona Governor Doug Ducey plans for Arizona to once again lead the way in health care reform, this time by seeking legislation to make permanent his emergency executive order that allows Arizona residents to obtain telehealth services from practitioners licensed in any of the 50 states and the District of Columbia. While many states have taken similar emergency steps to improve access to health care during this public health crisis, unless their legislatures act, the emergency orders will expire when the crisis is over. If Governor Ducey convinces Arizona legislators, Arizona will become the first state in the union to permanently allow out‐​of‐​state licensed health care practitioners to render telehealth services to its residents.

The Governor’s 2021 Policy Priorities reported that many Arizonans—particularly those in rural areas—benefited greatly from the emergency telehealth action, with behavioral health services among those most utilizing the remote technology.

Under current law, Arizona—like every other state—allows patients to travel out of state to receive medical treatment and even surgery from a doctor licensed in that state, but those same doctors cannot provide telehealth services to patients in Arizona without an Arizona license. Removing that requirement will give Arizonans access to care from the best health care practitioners in the country.

As the 2021 Policy Priorities states:

A person who is visiting a family here or spends the winter here, should be able to reach their doctor in their home state by telemedicine. A family in Mohave County who utilizes a hospital in Las Vegas, Nevada should be able to get follow up care via telemedicine. Today, someone who has the means to travel to a consultation with a specialist in another state can do so. Specialty doctors should not only be accessible via an expensive flight and hotel stay. If a specialty provider is willing to do a consult via telehealth, Arizona patients should have easy access to those services without unnecessary travel expenses and Arizona is going to lead the way on this. If it’s safe and it works during a pandemic, we should embrace it when we’re not in an emergency as well. (Emphasis added.)

When, in April 2019, Arizona Governor Doug Ducey signed into law HB2569, it made Arizona the first state to recognize all out‐​of‐​state professional and occupational licenses. As a result, any health care practitioner with a license in good standing in any of the other 49 states and the District of Columbia can now establish a practice in Arizona and the relevant state licensing boards will issue them an Arizona license. Unlike a license reciprocity law, which recognizes licenses of out‐​of‐​state license holders hailing from states that recognize Arizona licensees in return, this “universal” licensing law recognizes out‐​of‐​state license holders unilaterally.

In June of 2020 the Arizona‐​based Goldwater Institute reported that, since the law was enacted, “about 1,454 people have applied for an Arizona license under the law. Of those, at least 1,186 have had their licenses approved while only 16 have been rejected.” Among the boards granting the most approvals were those in the fields of behavioral health, social work, medicine, dentistry, occupational therapy, and clinical psychology.

Now Arizona can take the lead in liberating telehealth. Legislators in other states are also contemplating such reform.

This past November I was privileged to testify before a joint committee of the Idaho legislature that is considering telehealth reform. As expected, the committee received pushback from representatives of incumbent licensed health professions. They claimed to be very much in favor of telehealth, and supported state laws requiring insurance payments for telehealth services, but cautioned that it was unsafe to let Idahoans receive care from practitioners licensed in other states, even though every state has essentially identical license requirements and every state—including Idaho— licenses practitioners who received education and training in other states. Arizona legislators should expect similar resistance when they take on the Governor’s proposal. It’s understandable. If reform is enacted, practitioners would have additional competition from out‐​of‐​state.

Following Arizona’s lead, several states, including Pennsylvania, Missouri, Montana, and Utah have since enacted similar universal licensing laws. If Arizona enacts telehealth reform, expect other states to follow suit as well. Some critics claim that too many leaders prefer to carry out great reforms second—not first. That statement doesn’t appear to apply in Arizona.

January 4, 2021 5:15PM

Telehealth in the Time of COVID-19

By Jeffrey Miron and Erin Partin

A new year means a flurry of new legislation at the state and local levels. This year, as the Covid‐​19 pandemic continues to rage, Massachusetts Governor Charlie Baker signed a new health care bill that, among other provisions, expands access to telehealth services.

The use of telehealth visits has increased dramatically during the COVID-19 pandemic. One CDC report finds a 154 percent increase in telehealth visits in the last week of March 2020 (the latest available data) compared to the same week in 2019. More recent data, when available, will almost certainly show similar increases.

Promoting the use of telehealth services, particularly during a global pandemic, is a laudable goal. However, it is less clear that a state mandate that insurance companies provide telehealth coverage is the appropriate course of action. States should strive to eliminate restrictions on telehealth, not impose new burdens. Absent regulatory barriers restricting the provision of telehealth services, insurers, providers, and patients all have incentives to shift towards more telehealth services. Patchwork state laws and arbitrary barriers, including restrictions on cross‐​border telehealth, are the impediments to widespread adoption of telehealth, not insurance companies.

Nearly every state implemented changes to their telehealth requirements in response to the COVID-19 pandemic, but many of the accommodations have expired or are set to expire at the conclusion of the current health emergency. State legislatures should make these temporary allowances permanent and further remove regulatory barriers. Pandemic or not, telemedicine will play a larger role in the future, and lawmakers should promote – not discourage – its expansion.

January 3, 2021 7:40PM

Getting The Vaccine to Those Who Want it Most

The first wave of Pfizer and Moderna COVID vaccines arriving at health facilities across the country in the past few weeks sparked optimism that we may soon see a light at the end of the tunnel. As more people get vaccinated, the goal of herd immunity—where enough of the population is immune to the virus to prevent its easy spread to the vulnerable—becomes more attainable.

Markets provide the most efficient means of distributing the vaccine to those who want and need it. Instead, policymakers on all levels of government have chosen the opposite: central planning. Now we read of reports in the news than many frontline health workers—those assigned top priority for immunization—are not following the plan. They are reluctant to take the vaccine.

On New Year’s Day, the Los Angeles Times reported that anywhere from 20 to 50 percent of Southern California health care workers are refusing immunization. The New York Post reported similar resistance in New York, Ohio, and Texas.

This is very disappointing. Frontline health workers are not only at greater risk of contracting the virus but at greater risk of spreading it around their institution or bringing it home. It is reasonable to expect that, with their background in health care, they would have a greater appreciation for the value as well as the reported safety and efficacy of the two new vaccines. The longer it takes to get an estimated 70% of the population immunized, the longer it will take to reach herd immunity. (Of course, the millions of people who have already contracted and recovered from COVID are immune as a result and contribute to the goal of herd immunity as well.)

Many people who public health officials designated as lower priority for the vaccine are particularly frustrated to learn of this news. They very much want to receive the vaccine but are currently denied the chance, while vaccine vials allocated to first priority designees may go unused since manufacturers require them, regardless of any state policies or lack thereof, to be discarded if they are stored beyond safe time periods.

This unfortunate paradox—people denied vaccination while some unused vaccines are discarded— should come as no surprise to those aware of the failures of central planning. Markets provide the most efficient and accurate way of getting goods and services to those who most value them. In the face of the national public health crisis, policymakers instead resorted to central planning.

At this juncture, the federal government is the purchaser of all COVID vaccines and distributes them to state governments according to state population requirements. The states, in turn, delegate state, county, and municipal public health agencies to work with local health care providers to immunize the population. While the U.S. Centers for Disease Control and Prevention issued guidelines to prioritize who gets vaccinated, states reserve the right to establish their own priority schedules, and some states have not followed CDC recommendations.

Central planning suffers from a lack of local knowledge along with an inability to rapidly adjust to changes in supply and demand. Therefore, it is fortunate that our federal system allows for 51 different possible central plans instead of just one. This reduces potential harm from a one‐​size‐​fits‐​all plan and allows the various states to learn from one another’s experiences. In most instances, states are establishing phased approaches to immunizing the population. Initially, the highest priority groups receive the vaccine. Lower priority groups are phased in as vaccine supplies permit.

As long as central planning remains the approach to immunizing the population, one way to mitigate the unfortunate misallocation of vaccines described above might be to follow the approach most commercial airlines use for boarding planes. States should consider announcing in advance a schedule that, say, gives the first 2–3 weeks of vaccines only to the top priority people; then the next 2–3 weeks to the top plus the next priority level; then the next 2–3 weeks to the first three priority levels, and so on. This way, if first priority people choose not to take the vaccine, lower priority people who wish to take it will not miss out on the chance to do so before the first vaccine batch needs to be discarded. It would also incentivize people in the higher priority levels to hurry up and get vaccinated before the lines get longer.

This proposal might help to reduce the waste of precious vaccine and permit more people who both want and need the vaccine to get it.

December 31, 2020 12:29PM

Market Allocation Would Treat COVID-19 Vaccines Like the Valuable Resource They Are

News reports indicate that COVID-19 vaccinations in the United States are happening more slowly than officials promised and in comparison to other countries. Some health care providers are racing — and some are failing — to administer their stock vaccines before they expire. In one case, more than 500 doses spoiled when an employee removed them from a freezer, allegedly on purpose.

These episodes highlight just some of problems inherent to using government rationing rather than market prices to distribute vaccines.

If manufacturers and retailers could charge, and consumers could pay, whatever they like, distribution of COVID-19 vaccines likely would be more rapid than today and likely none of the existing stock would expire.

Photo by Hakan Nural on Unsplash

Anecdotal reports indicate that some consumers are willing to pay $25,000 to receive the vaccine. If retailers could make thousands or even hundreds of dollars in profit from every dose they sell, they would have the incentive and the ability to invest greater resources in securing the vaccines and distributing them quickly. They would take greater steps to protect the vaccines from sabotage by deranged employees. (The law could also do so, if penalties for destroying the vaccines rose with the market valuation of each dose.) They would hire more personnel (e.g., nurses) at higher‐​than‐​usual wages to organize distribution and/​or to administer the vaccines. They could even train more personnel to administer vaccines — and form a lobby to demand that states suspend government regulations that prevent them from doing so.

If manufacturers could make thousands or even hundreds of dollars in profit from every dose they sell, they would have greater incentive and ability to expand production and produce more vaccines faster.

Would market prices guarantee that vaccines would go to the highest‐​value recipients first? Not at all. But market allocation doesn’t have to be perfect. It just has to outperform the alternative of government rationing.

In an earlier post on government vs. market distribution of COVID-19 vaccines, I wrote, “If the government could allocate vaccines in a way that gets more of them to the highest‐​value recipients than market forces would,” then government distribution would be defensible. But, “To improve on market forces, government must actually know who the highest‐​value recipients are[,] actually be able to allocate vaccines on that basis, [and] not detract from whatever good market forces would do on their own, or…diminish the incentives for pharmaceutical companies to boost production.” That does not appear to be happening.

Government rationing is detracting from the good that market forces would do, and slowing the distribution of COVID-19 vaccines, by diminishing the incentives for speed and security on the part of manufacturers and retailers. In many cases, it is resulting in low‐​value recipients receiving vaccinations before high‐​valued recipients do. It is diminishing the incentives for manufacturers to accelerate production. And in some, cases it is costing lives by allowing vaccines to spoil.

December 30, 2020 10:55AM

The Great Bucatini Shortage of 2020 and the FDA’s History of Telling Italians How to Make Italian Food

Pasta with tomato sauce. Photo by Yeh Xintong on Unsplash.

Rachel Handler has a delightful piece at New York magazine’s food and restaurant blog Grub Street on how Big Pasta is using government regulation to punish competitors and consumers. The result is that the U.S. Food and Drug Administration, in addition to causing a shortage of COVID-19 diagnostic tests and vaccines, is basically causing a nationwide shortage of bucatini.

On March 30, at the beginning of a pandemic whose supply shocks were making everything from toilet paper to pasta harder to get, the FDA blocked imports of De Cecco bucatini. The FDA found the iron content of the Italian company’s bucatini to be—brace yourself—10.9 milligrams per pound rather than the 13 milligrams per pound the FDA requires. The product in question is perfectly safe. It presents no threat to the public. It is legal to sell throughout the European Union. But since the FDA alleges it does not meet the agency’s arbitrary standard, the agency turned a temporary shortage of bucatini into a…less-temporary one. Handler surmises the FDA took the action at the behest of one of De Cecco’s competitors.

You might think it implausible that the FDA would seize one manufacturer’s inventory at the behest of a competitor. If so, you would be wrong. The Great Bucatini Shortage of 2020 isn’t even the first time the FDA told Italians how to make Italian food. In a similar episode, the FDA once told a native Sicilian he didn’t know what tomato sauce is.

Rosario Raspanti was born in Palermo, Sicily, where his father ran a tomato‐​sauce cannery. After learning the trade from his father, in 1913 the younger Raspanti brought that knowledge to the United States. He established a canning factory in Mississippi, which he claimed made him the first canner of tomato sauce in America. Raspanti used practically the same process and sold practically the same product his father did. By 1942, Raspanti estimated he had sold some 100 million cans of tomato sauce to satisfied customers in Arkansas, Louisiana, Mississippi, and Western Tennessee.

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In 1942, however, the FDA seized 36,144 cans of his tomato sauce. The agency furnished no evidence the sauce was harmful to consumers. Its entire justification for seizing the items was that, in the FDA’s opinion, Raspanti’s sauce was thinner than tomato sauce should be and didn’t have enough seasoning.

At trial, Raspanti testified, reasonably, that his customers preferred tomato sauce that was both unseasoned (so they could then season it to taste) and thinner than his competitors’ (allowing them to consume it as‐​is or reduce it to whatever consistency they prefer). Others testified in Raspanti’s defense. Two food brokers with a combined 42 years of experience testified that wholesalers, retailers, and consumers alike all accepted Raspanti’s sauce as tomato sauce; that the trade accepted it over competing products by a ratio of 10 to 1; that one retailer said it enjoyed as much consumer acceptance as Arm & Hammer Baking Soda; that none complained the sauce was too thin or lacked seasoning; that consumers bought it because they preferred a thinner, unspiced sauce; and that they (the brokers) could easily sell a large amount of this established product if it were available. One of Raspanti’s competitors, another Sicilian who also operated a tomato‐​sauce cannery in Mississippi, testified Raspanti knew perfectly well what tomato sauce is and more important (for legal reasons) so did Raspanti’s customers.

I can’t recall if the FDA’s action stemmed from a complaint by one of Raspanti’s other competitors, but I believe that was the case. Either way, Raspanti’s other competitors helped the FDA convince Judge Harry Jacob Lemley, himself a native of rural Virginia and member of the U.S. District Court for the Eastern District of Arkansas, that Raspanti didn’t know how to make tomato sauce. At trial, witnesses for the government included “chemists employed by FDA and competitors, a plant manager employed by a competitor, a buyer and sales manager of a food wholesaler, a housewife, a chef, [and] a restaurant manager.” Several government witnesses testified, uniformly and with stunning precision, that true tomato sauce contains no less than 8.37 percent tomato solids. Raspanti’s crime was to produce a tomato sauce—the faint of heart should stop reading here—that contained only 6.5 percent tomato solids. Budding tomato‐​sauce expert Judge Lemley personally and thoroughly assessed these claims at trial: “A can of [Raspanti’s sauce] and certain cans of other brands were opened and exhibited to the Court, by whom they were tested by pouring and tasting.”

In ruling for the government, Judge Lemley conceded, “It is true that in…Louisiana, Arkansas, Mississippi, and Western Tennessee, the claimant’s product has been accepted by the consuming public as tomato sauce over a long period of time.” Lemley nevertheless concluded, with similar stunning precision, “There seems to be no question but that dealers in, and consumers of, tomato products generally throughout the United States consider tomato sauce to be a spiced product containing not less than 8.37% of salt‐​free tomato solids.” If Raspanti wanted to sell his tomato sauce in the United States, he would most likely have to relabel it a beverage in accordance with the assessment of one of the witnesses, who was “an expert on beverages, being in charge of the Beverage Section of the Food Division of the Food and Drug Administration.” Lemley ordered the government to re‐​label and sell the 36,144 seized cans of tomato sauce to the government’s benefit or, in the alternative, to release the items to Raspanti provided his company both paid the costs of the seizure proceedings and posted a bond conditioned on the company re‐​labeling the cans prior to sale.

“Government,” Barney Frank reportedly said, “is simply the name we give to the things we choose to do together.” Like tell Sicilians how to make tomato sauce.

December 23, 2020 11:54AM

Going After Scapegoats Is Easier Than Confronting The Truth

Yesterday the Department of Justice filed suit against the giant retailer Walmart, accusing it of fueling the opioid crisis by encouraging its pharmacists to fill prescriptions–legally written by health care practitioners licensed by the Drug Enforcement Administration–they should have suspected of being inappropriately prescribed.

The Justice Department seems uninterested in the fact that there is no correlation between the number of opioid prescriptions and the non‐​medical use of prescription pain reliever or the development of opioid use disorder. And while the number of opioid prescriptions has dropped 57.5 percent since 2010, the overdose rate has continued to climb, soaring to record high levels in the latest report from the Centers for Disease Control and Prevention.

In its complaint, the Justice Department continues to conflate “physical dependency” and “addiction,” seemingly ignorant of the difference between the two. It also apparently ignores the words of Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse who stated in a 2016 article in the New England Journal of Medicine:

Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with preexisting vulnerabilities. Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV).

Research shows the overdose rate has been climbing exponentially since at least the late 1970s, long before the creation of the potent prescription opioid OxyContin in 1996, and continues to climb. The only thing that has changed over the years has been the type of drug that has predominated among the overdose deaths. As Josh Bloom, the director of chemical and pharmaceutical science at the American Council on Science and Health, and I recently pointed out, the top killers are now fentanyl, heroin, cocaine, and methamphetamine. In fact, prescription opioids have consistently been a very small component of the drugs involved in overdose deaths for quite some time. We explain that policymakers’ obsession with reducing opioid prescribing has converted the “opioid crisis” into a “street drug crisis.” It has also inflicted great harm on acute and chronic pain patients, driving some, in desperation, to the dangerous black market in search of relief.

While policymakers and prosecutors exact tribute from scapegoats that are soft targets, they let the true offender get away: drug prohibition.

December 18, 2020 10:49AM

Pandemic Plus Drug Prohibition Form a Lethal Combination

Yesterday, the Centers for Disease Control and Prevention reported that the drug overdose death rate, already accelerating after a brief pause in 2018, increased at an alarming rate coinciding with the mobility restrictions and emotionally stress of the COVID-19 pandemic. There were more than 81,000 overdose deaths during the 12 months ending in May 2020—a new record. There were just over 71,000 deaths reported for the 12 months ending in December 2019.

To be sure, the isolation, loneliness, and anxiety of the pandemic and its management exacerbate mental health problems, including substance use disorder. Their effect on the overdose rate was noted by White House “drug czar” Jim Carroll in the late spring of this year.

But the most important feature of the latest report from the CDC is the fact that illicit fentanyl, made in clandestine labs in Asia and Mexico, was responsible for roughly 57 percent of all overdose deaths. Cocaine was found in roughly 22 percent of overdoses. And methamphetamines were found in 23 percent of all overdose deaths.

Yet the CDC maintains its focus on doctors prescribing opioids to their patients in pain in its list of recommendations for dealing with this dispiriting news. It tells health care providers to co‐​prescribe the opioid overdose antidote naloxone to their pain patients when they prescribe high doses of opioids—despite the fact that prescription opioids account for an ever‐​decreasing percentage of the drugs involved in overdose deaths, with overwhelming evidence that the overdoses are from illicit drugs obtained in the black market. As Josh Bloom and I recently pointed out, the crackdown on prescription opioids has fueled a “street drug epidemic” while it has harmed patients in pain.

The CDC also gives lip service to a few harm reduction strategies in its recommendations. For example, it recommends more widespread distribution of the overdose antidote naloxone, without urging the Food and Drug Administration to reclassify naloxone as an over‐​the‐​counter drug—an obvious way to increase its dissemination.

The CDC also encourages the expansion of medication assisted treatment (MAT) programs with drugs such as methadone and buprenorphine, which it recognizes as the most effective form of treatment for substance use disorder due to opioids. Yet it makes no mention of proposals to deregulate methadone and buprenorphine treatment programs by letting health care practitioners more easily prescribe these drugs to their patients, as they do in many developed countries. Congress can build upon the temporary relaxation of MAT regulations during the COVID pandemic and implement permanent reforms.

The tragic report by the CDC lacks the boldness to admit that restricting patients’ access to legal drugs (e.g., prescription opioids in the case of opioid‐​related deaths and pseudoephedrine in the case of methamphetamine‐​related deaths) has, if anything, inflamed the drug overdose crisis while harming patients. It failed to argue for reforming or repealing laws that obstruct harm reduction strategies. So it should come as no surprise that it failed to identify the ultimate source of the drug overdose crisis: drug prohibition and the dangerous black market it fuels.