Two weeks ago, a federal appeals court upheld the freedom of consumers to purchase health plans that are exempt from the Affordable Care Act’s costly regulations; that consumers can purchase year‐round; and that can cover enrollees for a full year—including during the 10‐month period that the ACA prohibits consumers from purchasing ACA plans. Short‐term, limited duration insurance (STLDI) plans offer consumers additional choice. Since they are exempt from the ACA, they cost dramatically less than ACA plans and often offer greater choice of health care providers.
Last week, I published an oped in The Hill praising the appeals‐court ruling. I noted that the lead plaintiff in the case is a lobbying group—the Association for Community Affiliated Plans—that represents private insurance companies who sell ACA plans. The group asked the courts to impose a rule that would throw STLDI enrollees out of those health plans after just three months. Insurance regulators at the National Association of Insurance Commissioners have warned such a rule would strip coverage from sick patients, leaving them uninsured for up to an entire year. As it turns out, the regulators were right: when that rule was briefly in place during 2017, it stripped Arizona resident Jeanne Balvin of her STLDI plan, leaving her with $97,000 in hospital charges and no coverage.
ACAP nevertheless admitted in court both that it brought the case because STLDI plans were cutting into its members’ revenues, and that it wanted the courts to throw STLDI enrollees out of their plans after three months because that would improve its members’ revenues. I wrote:
Complaining that STLDI plans were cutting into their business, ACAP asked federal courts to remedy that “injury” by reinstating this heartless rule.
To be clear: ACAP is asking federal courts to improve its members’ bottom lines by stripping coverage from their competitors’ enrollees after three months, because doing so will frighten consumers into enrolling in ACAP members’ plans. ACA plans must not be very attractive if the insurers who sell them feel they cannot compete unless the government actively punishes people who choose their competitors’ plans.
Today, The Hill published an equal‐length rebuttal by Margaret A. Murray, the head lobbyist for ACAP. The oped is heavy on rhetoric. It labels STLDI plans “junk insurance,” for example, a phrase that appears an average of once per paragraph. (More about junk insurance in a moment.) Worse, the oped gets crucial facts wrong.
It claims, incorrectly, that ACA plans neither deny coverage for preexisting conditions nor impose lifetime caps on benefits. On the contrary, for 10 months every year, ACA plans do both. In effect, and with few exceptions, the ACA prohibits enrollment in ACA plans except during a narrow window in November and December. During the other 10 months of the year, the ACA effectively offers a benefit limit of $0. As any honest ACA supporter will tell you, the purpose of that restriction is to block people with preexisting conditions from enrolling in coverage during those 10 months.
For 10 months every year, therefore, STLDI plans offer more comprehensive coverage than ACA plans. You can see for yourself: call up one of the insurance companies Ms. Murray represents and one STLDI issuer, tell them you would like to enroll in one of their health plans right now, and see how much coverage each insurer offers you.
ACA plans deny coverage to people with preexisting conditions in other ways as well. Last week, the Cato Institute held a forum exploring the case of seven‐year‐old leukemia patient Colette Briggs. ACA‐participating plans have repeatedly dropped coverage for Colette’s cancer treatment. Colette’s parents have had to fight with insurance companies, plead with Congress, and go to the media to get ACA plans to cover Colette’s care. They often failed.
ACA plans are treating Colette this way for the same reason economists have found ACA plans are getting increasingly worse for patients with other expensive illnesses: the ACA literally rewards insurers who discriminate against such patients in these ways. Chances are extremely high that ACAP’s members are doing the same. (Who’s selling junk insurance now?) If both ACA and STLDI plans have downsides, why not let consumers decide which they prefer?
There are plenty of other problems with Murray’s oped. It claims STLDI plans engage in misleading marketing, yet it neither substantiates that allegation nor acknowledges the ACA owes its existence to misleading marketing. (Sprechen Sie, “If You Like Your Health Plan, You Can Keep It”?) It derides measures that protect consumers and insurers from fraud as if they were some evil plot. It fails to recognize that when STLDI plans offer less coverage than ACA plans, they are reflecting consumers’ preferences.
But the biggest problem with Murray’s oped is its refusal to take responsibility for ACAP’s actions. Insurance regulators have warned ACAP’s desired rule will strip coverage from, and deny care to, sick patients. ACAP has admitted in federal court that it is pursuing that rule in order to improve its members’ bottom lines. Murray’s oped blames everyone else in sight for the damage everyone knows her organization’s actions would cause in the pursuit of more money for its members.
In the most recent issue of Public Health Reports, the official journal of the U.S. Public Health Service, Surgeon General Jerome Adams restated his strong support of syringe services programs (SSPs). While most people know of them as “needle exchange programs,” “syringe services programs” more accurately describes them because they actually provide a much wider array of services in addition to providing clean needles and syringes to people who inject drugs.
As Dr. Adams pointed out when he spoke at the Cato Institute last January, such programs distribute opioid overdose antidote naloxone, offer screening tests and treatment referrals for HIV and hepatitis C, and have brought many users with substance use disorder into rehab programs. With the advent of the COVID-19 pandemic SSPs can also provide COVID-19 testing.
Dr. Adams’ commentary in Public Health Reports detailed the long and proven track record of SSPs in reducing the spread of HIV and hepatitis. Now that they are distributing naloxone, they are likely to reduce overdose deaths.
The federal government does not prevent states from legalizing SSPs, and the Surgeon General along with the National Academy of Sciences, Engineering and Medicine are encouraging states to allow them to proliferate. Unfortunately, state‐based drug paraphernalia laws make them illegal in 20 states. My state of Arizona is one of them.
Hopefully, if the Surgeon General continues to promote them, lawmakers in the holdout states will soon come to their senses.
The COVID-19 pandemic has placed another stumbling block in the way of the Drug Enforcement Administration’s futile effort to reduce the country’s drug overdose rate through quotas on the manufacture of all forms of prescription opioids.
The DEA’s annual quotas have brought production levels more than 50 percent below 2016 levels. But, in response to the COVID-19 pandemic, the agency increased this year’s quota by 15 percent, to allow drug makers to respond to pandemic‐induced shortages. Intravenous opioids such as fentanyl are valuable tools used to manage patients on ventilators—as well as inducing general anesthesia—and the DEA recognized the pandemic would likely increase demand for such drugs. Unfortunately, the agency conflates prescription opioid pills used in the non‐hospital setting with intravenous opioids like fentanyl and morphine, almost exclusively used in hospitals, when it adjusted the manufacturing limits.
This has generated a shortage of intravenous opioids, causing many hospitals to cancel or delay necessary procedures and has jeopardized the management of patients on ventilators, according to a July 22 report from the hospital policy group Premier.
This is not the first time that DEA opioid production quotas caused a critical shortage in hospitals. I wrote here about the shortage the agency helped create in 2018.
While hospitals and patients suffer from the DEA’s war on opioids, fentanyl and other IV opioids are plentiful on the street. We learned last week in a preliminary report by the Centers for Disease Control and prevention that drug overdose deaths increased from 67,367 in 2018 to 70,980 in 2019. And deaths attributable to fentanyl increased by 15 percent, from 31,529 in 2018 to 36,509 in 2019.
Policymakers continue to believe that reducing the prescribing of opioids will somehow lead to a reduction in their non‐medical use, addiction, and overdose deaths. This false hope persists despite the fact that data from the CDC and the National Survey on Drug Use and Health show no association between prescription volume and non‐medical opioid use or addiction.
The drug overdose crisis is caused by non‐medical users accessing drugs in the dangerous black market that is fueled by drug prohibition. But drug prohibition doesn’t only harm non‐medical drug users. It harms patients as well—including critically ill patients in hospitals.
National Public Radio released an investigative report today showing that doctors and dentists are still prescribing opioids for pain management at “rates widely considered unsafe.”
This persistent focus on the number of pills doctors prescribe defies justification in light of the fact that data from the Centers for Disease Control and Prevention and the National Survey on Drug Use and Health consistently reveal no association between prescription volume and the non‐medical use of prescription opioids or addiction.
And despite the overall prescription volume coming down dramatically since 2012 (the year the volume peaked), overdose rates continue to climb. In fact, the overdose rate climbed as prescription rates came down. We learned this week that overdoses in 2019 are up considerably over the previous year and the situation this year is exacerbated by the COVID-19 crisis.
Meanwhile, what prescription amounts that are “widely considered safe” is a matter for debate. The CDC in 2019 issued a memo claiming policymakers were misapplying and misinterpreting the opioid prescribing guidelines they published in 2016, and reminded policymakers that they were meant to be suggestive, not prescriptive. Around the same time a Department of Health and Human Services Pain Management Best Practices Inter‐Agency Task Force issued a report calling for the individualization of pain management practices, deferring to practitioners to weigh the risks and benefits when recommending medications and dosages to their patients. And the American Medical Association in June came out against governments imposing prescription and dosage limitations.
NPR should take note of the developments over the past nine to ten years since the press and policymakers adopted the mantra that opioid prescriptions must be brought down to end the overdose crisis and change its focus to the real cause of the overdose crisis: drug prohibition.
When the Centers for Disease Control and Prevention announced last January that drug overdoses in 2018 declined by 4.1 percent–from 70,237 in 2017 to 67,367 in 2018–many in the press took that as a sign of possible progress in America’s longest war, the war on drugs. However, a deeper look at the data painted a very different picture.
The CDC report stated:
The age‐adjusted rate of drug overdose deaths involving synthetic opioids other than methadone, which include drugs such as fentanyl, fentanyl analogs, and tramadol, increased from 0.3 per 100,000 standard population in 1999 to 1.0 in 2013, 1.8 in 2014, 3.1 in 2015, 6.2 in 2016, 9.0 in 2017, and 9.9 in 2018. The rate of drug overdose deaths involving heroin increased from 0.7 in 1999 to 1.0 in 2010, then increased to 4.9 in 2016 and 2017. The rate in 2018 (4.7) was lower than in 2017. The rate of drug overdose deaths involving natural and semisynthetic opioids, which include drugs such as oxycodone and hydrocodone, increased from 1.0 in 1999 to 3.1 in 2009, then increased to 4.4 in 2016 and 2017. The rate in 2018 (3.8) was lower than in 2017… The age‐adjusted rate of drug overdose deaths involving cocaine increased from 1.4 per 100,000 standard population in 1999 to 2.5 in 2006, then decreased to 1.3 in 2010 and 1.5 in 2011. From 2012 through 2018, the rate increased on average by 27% per year to a rate of 4.5 in 2018. The age‐adjusted rate of drug overdose deaths involving psychostimulants with abuse potential, which include drugs such as methamphetamine, amphetamine, and methylphenidate, increased from 0.2 in 1999 to 0.8 in 2012. From 2012 through 2018, the rate increased on average by 30% per year to a rate of 3.9 in 2018.
While deaths attributed to prescription opioids continued to decline, deaths attributed to heroin overdoses levelled off and those attributed to fentanyl and its analogs continued to increase. Also making a big comeback were deaths related to psychostimulants, such as cocaine and methamphetamine. These data should have been enough evidence to prevent policymakers from cracking open the champagne bottles.
The CDC recently issued its preliminary report on 2019 overdose deaths and the news isn’t good. There were roughly 71,000 overdose deaths, a new record. These data predate the COVID-19 crisis, so we can expect matters to get even worse.
Speaking to reporters about the preliminary report, Robert Anderson, who oversees the mortality data for the CDC said, “We got it to stall out a bit. Now we need to grab on again and not let this get away from us.”
This should come as no surprise. A 2018 study by researchers at the University of Pittsburgh found overdose deaths have been growing exponentially since at least the late 1970s and show no sign of deviating from the trend line. The particular drug predominating as the cause of death has changed from time to time, but the death rate marches on relentlessly. Therefore, even if the aggregate overdose data “stalled” a bit in 2018, the underlying forces fueled by dangerous black market drugs that result from drug prohibition continue unabated.
One bright spot in the preliminary data: overdoses declined in Vermont, Massachusetts, New York, New Hampshire, and Rhode Island—states where harm reduction strategies have gained some traction.
Until drug prohibition ends expect overdoses to continue following the tragic trendline.
Waging a war on drugs is like playing a game of Whac‐A‐Mole.
In 2005 Congress addressed the “meth crisis” by passing the Combat Methamphetamine Epidemic Act that, among other things, made the popular decongestant Sudafed, used by homegrown labs to make meth, a behind‐the‐counter drug and restricted its sale to patients. It didn’t take long for Mexican drug cartels to fill the void created by the crackdown on domestic meth labs, and to find other and better ways to manufacture meth. Now the Centers for Disease Control and Prevention report methamphetamine‐related deaths at record high levels.
Reacting to the fact that the synthetic opioid fentanyl and its analogs— largely made and smuggled into the U.S. by labs in China—is responsible for up to 75 percent of opioid‐related deaths, the Trump administration persuaded China to impose a ban on the production of fentanyl and its analogs in April 2019. By the fall of 2019 a new synthetic opioid, isotonitazene, made its debut in U.S. and Canadian black markets. The drug, which is not a derivative of fentanyl but equally as potent, is legal to export from China and is not banned in North America or Europe.
In March of this year Vice gave a detailed report on how this synthetic opioid has been found in counterfeit Dilaudid tablets sold on the streets in Nova Scotia, mixed with heroin sold in the U.S., and is sold in underground markets in Europe.
Research by the University of Pittsburgh shows that overdose deaths from licit and illicit drugs have been increasing exponentially since at least the late 1970s and show no signs of slowing. The drug that predominates as the cause of death has changed over the years, but the trend continues. In the beginning of this century prescription opioids that were diverted to the street were predominant. As prescriptions of opioids dropped, non‐medical users migrated to heroin. Soon thereafter fentanyl and its analogs emerged on the scene, and now make up the bulk of opioid‐related overdose deaths.
As efforts are underway to crack down on illicit fentanyl, don’t be surprised if isotonitazene is the next big thing.
Last October, California expanded the scope of practice of pharmacists to allow them to prescribe HIV pre‐exposure prophylaxis (PrEP) and post‐exposure prophylaxis (PEP) to people at risk. Similar legislation is currently being considered by the New York state legislature.
I have argued here that the Food and Drug Administration should reclassify PrEP and PEP as over the counter. While allowing pharmacists to prescribe PrEP and PEP is a step in the right direction, it would greatly improve access to the drugs for people at risk if they were available OTC. They can then be sold in retail and convenience stores in addition to drug stores. They might even be made available in vending machines, as is the case with emergency contraceptives, providing greater privacy along with convenience.
Research published this month by a team at the University of California San Francisco strengthens the argument for the FDA to move quickly on this. A randomized controlled trial of nearly 75,000 people in East Africa, an area of the world most affected by HIV, found PrEP resulted in a 74 percent reduction in new cases of HIV. The study found a 40 percent reduction in incidence among men and a 76 percent reduction among women. This latter discovery is particularly important, because clinical researchers have been uncertain as to the effectiveness of PrEP in women.
Medpage Today reported Catherine Koss, MD of the University of California San Francisco as saying:
“This shows in generalized epidemic settings, offering universal access to PrEP can reduce HIV incidence,” Koss said. “Moving forward, comprehensive HIV testing with linkage to treatment and prevention, including PrEP … [is a] promising approach to accelerated reductions in new infections.”
In response to the COVID-19 pandemic the FDA, in early March, relaxed many of its outdated and onerous regulations in order to fast‐track the approval process for new tests and new drugs to combat the virus.
While the COVID-19 virus is on everyone’s mind, the HIV epidemic has been around for more than 40 years, with more than 36,000 people infected each year and 1.2 million Americans living with HIV.
The FDA should demonstrate the same commitment to the fight against HIV that it claims to have against COVID-19 by reclassifying PrEP and PEP OTC. ASAP.