LAC and RTI: Eliminate Medicaid prior auth for bupe

Since April 2018, Medicare limited utilization management — most often done via prior authorization requirements — for buprenorphine to treat opioid use disorder (OUD). In response, virtually all plans that covered this treatment removed prior authorization requirements. Medicaid plans should do the same, according to RTI, writing in the July 9 issue of the Journal of the American Medical Association (JAMA).     

‘Secret shopper’ study finds many barriers to OUD treatment

Treatment programs that don't accept insurance, but only cash, create a barrier for opioid use disorder (OUD) treatment, according to a study by Stephen Patrick, M.D., and colleagues, many of whom are from the Vanderbilt Center for Child Health Policy at Vanderbilt University Medical Center in Nashville. And despite the fact that pregnant women with OUD are a priority population for treatment due to the risks to the fetus of continued opioid abuse, nonpregnant women are more likely than pregnant women to be given an appointment for treatment with a buprenorphine‐waivered clinician.     

More from Louis Baxter on doctors taking MAT

The question of whether or not doctors and other health care professionals on medication‐assisted treatment (MAT) are safe to practice medicine has been debated for the last few years since the advent of Food and Drug Administration (FDA)–approved MAT for opioid use disorder (OUD). The newly approved medications have been primarily buprenorphine formulations for OUD, naltrexone formulations for OUD and alcohol use disorder (AUD), and, most recently, an alpha 2‐adrenergic medication that specifically targets amelioration of opioid‐withdrawal symptoms from OUD (lofexidine). Quite frankly, the question of safety about medications to treat substance use disorder (SUD) has been asked since the development of methadone for OUD treatment more than 30 years ago.     

Braeburn asks FDA to revoke Sublocade's orphan designation

Braeburn, which makes Brixadi, a buprenorphine injection, has filed a Citizen Petition calling on the Food and Drug Administration (FDA) to revoke “orphan designation” — exclusivity — for Sublocade, Indivior's injectable buprenorphine. Saying that unless the FDA does this, no competitive buprenorphine opioid use disorder (OUD) treatment will enter the market until 2024, Braeburn said the Orphan Drug Act was enacted to treat rare conditions with small patient populations. In some cases, the act is utilized even if a large population could benefit, if there is “no reasonable expectation” of recovering developing and marketing costs. Indeed, orphan drug designation (ODD) was granted to Subutex (buprenorphine) in 1994, when Indivior's predecessor was the sponsor. Now the FDA has “grandfathered” the Subutex designation to Sublocade “simply because the developer of Subutex and Sublocade is the same,” according to a press statement from Braeburn released earlier this month.     

Barriers to treating youth with medications for OUDs

Strategies to get medications to treat opioid use disorder (OUD) to young people immediately after diagnosis are urgently needed, a study published in the September issue of JAMA Pediatrics concluded. Young people with OUDs who receive naltrexone, methadone or buprenorphine are more likely to stay in treatment, yet these medications are underused. Only one in four youths receive medications for OUD shortly after diagnosis. For youths under 18, it's one in 21.     

States call on HHS to immediately change year‐1 bupe cap

A coalition of 22 states and territories is requesting that the federal Department of Health and Human Services (HHS) lift restrictions on providing buprenorphine, one of the only three federally approved medications to treat opioid use disorder (OUD). “Buprenorphine is an essential tool in the fight to end the opioid epidemic,” said Howard Zucker, M.D., commissioner of health for New York state, which is leading the initiative. “Removing federal restrictions on prescribing buprenorphine will ultimately save lives and eliminate unnecessary barriers that prevent people with opioid use disorder from having access to treatment,” he said.     

New OBOT program to open in Tennessee in response to COVID‐19

Spero Health is opening a new OBOT (office‐based outpatient treatment) center for patients with opioid use disorder (OUD) in Savannah, Tennessee, in response to the high demand for treatment in the COVID‐19 pandemic. This clinic will utilize telehealth and in‐person visit options. Spero Health has more than 35 clinics thro‐ughout Kentucky, Ohio, Indiana and Tennessee, treating more than 7,000 patients a month. Spero Health accepts TennCare, the state's Medicaid plan, and most commercial insurance plans.     

When naloxone alone isn't enough: Deaths in year after ED OD visits

When patients are treated for nonfatal opioid overdose in the emergency department (ED) and discharged, they have a high risk of death — 67% of the time from another overdose within the next year, and especially within the next two days — new research has found. Being offered medication such as buprenorphine, counseling and referral to treatment by the ED before discharge could reduce that risk, the researchers concluded.     

Fiellin: Keep the prescriber training for buprenorphine

It seems that almost everyone wants to deregulate buprenorphine for opioid use disorder (OUD) — with proposed legislation focused on getting rid of the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver altogether (see ADAW, Oct. 11, “Bill to deregulate buprenorphine raises concerns among OTPs,” https://onlinelibrary.wiley.com/doi/10.1002/adaw.32510 ).     

Pharmacy model for methadone,NAS link to demographics

In “Methadone Matters: What the United States Can Learn from the Global Effort to Treat Opioid Addiction,” senior author Jeffrey H. Sabet, M.D., and colleagues write about the lack of access to methadone treatment, in particular, for opioid use disorder (OUD) in the United States. They look at three pharmacy‐based models that exist in other countries. In their article, published online Feb. 6 in the Journal of General Internal Medicine, they promote the model of patients picking up methadone from pharmacies, as is done in, for example, Canada. The study was funded by the National Institute on Drug Abuse (NIDA) (from the United States) and cited by many as a call to reform the current opioid treatment program (OTP) system in the United States, where patients often prefer buprenorphine simply because they don't have to abide by methadone regulations.     

Briefly Noted

We asked Jerry Rhodes, former top executive at CRC (now Acadia) and a leader in opioid treatment program management, what he thinks of methadone as a medication to be used in primary care to treat opioid use disorder (OUD), as some people — including former Office of National Drug Control Policy Director Michael Botticelli — recommended last year (see ADAW, July 16, 2018). “I take issue with that,” said Rhodes. “Methadone is a dangerous drug in an unregulated environment,” he told ADAW. Buprenorphine is prescribed this way, but “buprenorphine is a relatively safe drug, and methadone isn't,” he said. A veteran of many battles over methadone, including the near‐elimination of opioid treatment programs, Rhodes told ADAW that “you don't give unfettered access to methadone” to patients with OUD. “Be careful what you wish for” is his advice. This has the potential to cause harm, he said. “Only people who don't understand the history of its utilization would recommend this.”     

Opioid withdrawal not lethal to fetus,if via medication taper

First of all, this story is not about Craig Towers, M.D., the charismatic Tennessee‐based OB‐GYN whose methods for detoxing pregnant women from opioids are not endorsed as standard of care by the American College of Obstetricians and Gynecologists. It is, however, about debunking the myth that pregnant women with opioid use disorder (OUD) must be maintained on agonist medication (methadone or buprenorphine). They don't need to be. They can be tapered instead.     

Using cannabis to mitigate symptoms of opioid use disorder

Results of a study published this month in Psychiatric Services suggest that if states want to ensure greater provision of evidence‐based care for opioid use disorder (OUD), expanding Medicaid offers an effective strategy for doing so. At the same time, the study data indicate that Medicaid expansion alone is not sufficient for making agonist therapies accessible in dramatic numbers.     

Sources of health insurance and characteristics of the uninsured: analysis of the March 2000 Current Population Survey

This Issue Brief provides summary data on the insured and uninsured populations in the nation and in each state. It discusses the characteristics most closely related to an individual's health insurance status. Based on EBRI estimates from the March 2000 Current Population Survey (CPS), it represents 1999 data--the most recent available. In 1999, for the first time since at least 1987, the percentage of Americans with health insurance increased: 82.5 percent of nonelderly Americans (under age 65) were covered by some form of health insurance, up from 81.6 percent in 1998. The percentage of nonelderly Americans without health insurance coverage declined from 18.4 percent in 1998 to 17.5 percent in 1999. The main reason for the decline in the number of uninsured Americans is the strong economy and low unemployment. Between 1998 and 1999, the percentage of nonelderly Americans covered by employment-based health insurance increased from 64.9 percent to 65.8 percent, continuing a longer-term trend that started between 1993 and 1994. In 1999, 34.1 million Americans received health insurance from public programs, and an additional 15.8 million purchased it directly from an insurer. Twenty-five million Americans participated in the Medicaid program, and 6.5 million received their health insurance through the Tricare and CHAMPVA programs and other government programs designed to provide coverage for retired military members and their families. Despite expansions in the State Children's Health Insurance Program (S-CHIP), public health insurance coverage did not increase overall between 1998 and 1999. The percentage of nonelderly Americans covered by Medicaid and other government-sponsored health insurance coverage did not change between 1998 and 1999, though some children benefited from expansions in government-funded programs. The percentage of children in families just above the poverty level without health insurance coverage declined dramatically, from 27.2 percent uninsured in 1998 to 19.7 percent uninsured in 1999. Some of the decline can be attributed to expansions in Medicaid and S-CHIP, but it appears that expansions in employment-based health insurance and individually purchased coverage had an even larger effect than expansion of S-CHIP. Even though the number and percentage of uninsured declined substantially between 1998 and 1999, more than 42 million Americans remain uninsured. As long as the economy is strong and unemployment is low, employment-based health insurance coverage will expand and the uninsured will decline gradually. If the economy continues to soften or comes close to a recession, the number of uninsured would easily and quickly start to increase again as unemployment rises. Should a severe downturn in the economy occur, causing the uninsured to represent 25 percent of the nonelderly population, 63 million Americans would be uninsured.     

Sources of health insurance and characteristics of the uninsured. Analysis of the March 1992 Current Population Survey

Eighty-three percent of nonelderly Americans and 99 percent of elderly Americans (aged 65 and over) were covered by either public or private health insurance in 1991, according to EBRI tabulations of the March 1992 Current Population Survey (CPS). The March 1992 CPS is the most recent data available on the number and characteristics of uninsured Americans. In 1991, 16.6 percent of the nonelderly population--or 36.3 million people--were not covered by private health insurance and did not receive publicly financed health assistance. This number compares with 35.7 million in 1990 (16.6 percent), 34.4 million in 1989 (16.1 percent), and 33.6 million in 1988 (15.9 percent). The most important determinant of health insurance is employment. Nearly two-thirds (64 percent) of the nonelderly have employment-based coverage. Workers were much more likely to be covered by group health plans than nonworkers (71 percent versus 40 percent). Even though workers and members of their families were more likely to be covered by health insurance than nonworkers, 85 percent of the uninsured lived in families headed by workers in 1991, primarily because most people lived in families headed by workers. More than 60 percent of uninsured were in families headed by full-year workers with no unemployment. Nearly all persons who were covered by an employment based-plan received at least some contribution to that plan from their employer. The estimated average annual contribution among those receiving a contribution to employee or family plans was $2,129. Although many individuals in poor families are covered by public health plans, that coverage is far from universal. In 1991, only 52 percent of the nonelderly with income below the poverty line were covered by a public plan--49 percent by Medicaid. The number of children who were uninsured in 1991 was 9.5 million, or 14.7 percent of all children, compared with 9.8 million or 15.3 percent of all children in 1990. Twenty-three percent of children were covered by public health insurance, with 21 percent being covered by Medicaid. In 11 states and the District of Columbia, more than 20 percent of the population was uninsured in 1991. These states and their uninsured rates were the District of Columbia (30.3 percent), Texas (25.3 percent), New Mexico (24.5 percent), Louisiana (23.8 percent), Florida (23.5 percent), Mississippi (22.1 percent), Oklahoma (22.1 percent), Nevada (21.8 percent), California (21.7 percent),Arizona (21.1 percent), Alabama (20.6 percent), and Idaho (20.6 percent).     

Modeling the Impact of the Affordable Care Act and the Individual Mandate on Californians

The Patient Protection and Affordable Care Act (ACA) was designed to provide health insurance to uninsured or underinsured individuals. We used the California Simulation of Insurance Markets (CalSIM) model to predict the experience of consumers in California, who will be faced with new insurance options through Medicaid, employer-sponsored insurance, and the individual market in 2014 and beyond. We explored the response and characteristics of Californians who will and will not secure insurance coverage, with and without the “individual mandate” or minimum coverage requirement (MCR). We found 1.8 million Californians (38 %) of the 4.7 million eligible uninsured will secure coverage by 2019 with the MCR, while only 839,000 (18 % of the eligible uninsured) would obtain coverage without it.     

Physicians,hospital face $9 million lawsuit following fatal OD

Two years ago, Victor Williams, a 56‐year‐old Black man, died from a fatal overdose of fentanyl and fentanyl analogs. He was at home, but his family didn't have any naloxone, because he had not been given any by his treatment provider, despite multiple previous ODs. He had an opioid use disorder (OUD) and instead of being prescribed methadone or buprenorphine, he was prescribed Schedule II analgesics in the hospital. Just hours before his fatal OD, the hospital discharged him after an accidental heroin poisoning.     

Drug users who only need treatment should get it,not arrest and incarceration

Many changes at the local, state and federal levels have resulted in getting treatment to at least some people with opioid use disorder (OUD) in prisons and jails — treatment that just a few years ago would have been unthinkable in those very institutions. Lawsuits over inmate deaths have been followed by establishment of methadone and buprenorphine treatment in some locations, while others have been moving toward treatment as a matter of public policy, Paul Samuels, director and president of the Legal Action Center, told the attendees of the American Association for the Treatment of Opioid Dependence (AATOD) conference in Orlando, Florida, last month. He was joined by a jail accreditor, a sheriff and a judge at the plenary on corrections.     

Veto of New York buprenorphine PA bill angers advocates

New York Governor Andrew Cuomo's veto on Jan. 1 of a bill that would have removed prior‐authorization barriers for all formulations of buprenorphine in the Medicaid program was greeted with dismay by the Legal Action Center and others who had fought hard for it. He did, however, sign a similar bill that removed prior‐authorization buprenorphine barriers for commercial insurance. So, it is only the poor who will be adversely affected.