DEA – Addiction Treatment Forum

DEA’s Foot-Dragging on Mobile Vans Gets Worse

December 17, 2018

By Alison Knopf

More than two years ago, just before Donald Trump was elected president, Demetra Ashley, associate deputy assistant administrator of the office of diversion control with the Drug Enforcement Administration (DEA), told the American Association for the Treatment of Opioid Dependence (AATOD) that new licensing regulations that would provide for more mobile vans to provide methadone and buprenorphine for opioid use disorders were in the works. She told the AATOD board the same thing a few months later, just before the inauguration. A year later, however, the discussion appeared stalled.

It still is.

“I was advised that new regulations can take years to be issued, because they not only have to go through internal DEA review but also interagency review, including both other federal agencies and White House offices, such as the Office of Management and Budget,” said Barbara L. Carreno, DEA spokeswoman, in an email to AT Forum in December. “These new regulations are one of our top priorities, on which we are working diligently,” she said. Her source (at diversion control) “did not know how close to coming out these regulations are,” she added.

Department of Justice Under Extreme Pressure

To be fair, the Department of Justice, DEA’s parent department, has been under extreme pressure lately, to put it mildly. Attorney General Jeff Sessions stepped down—in the face of being fired—on November 7, the day after the midterms. The entire department has been caught up in issues that are not related to methadone or the opioid crisis, but fortunately for patients with opioid use disorder, the Department of Health and Human Services has been giving the subject a lot of attention. The Substance Abuse and Mental Health Services Administration, which is headed by HHS, sent its mobile van recommendations to the DEA years ago. The issue is now in the DEA’s court, where it has been for some time.

The idea was to connect these mobile vans to existing brick-and-mortar opioid treatment programs. To that end, some states are spending federal grant money to purchase the vans, using them for outreach, with the hope that one day, the vans can actually transport medication. In some places of the country, this is already happening. But the federal regulations need to change if mobile vans are to be helpful on a widespread basis.

For more coverage on this issue, see

http://atforum.com/2018/09/new-york-str-funds-enhance-treatment/

http://atforum.com/2018/04/aatod-conference-recap-field-has-funding-now-needs-infrastructure/

http://atforum.com/2017/08/mobile-vans-otps-closer-reality/

Surgeon General: Federal Drug Classification Needs Changes

December 17, 2018

“The nation’s drug classification system should be revisited but illegal drugs shouldn’t simply be decriminalized nationwide, U.S. Surgeon General Jerome Adams told a gathering of police leaders focused on the opioids crisis Thursday in Boston.

“Our scheduling system is functioning, but not as ideally as it could,” he said of the federal schedule for controlled substances maintained by the Drug Enforcement Administration and the Food and Drug Administration. “Things aren’t static. We have to continue to evolve.”

Adams, who serves as the primary adviser on public health and scientific issues for U.S. Secretary of Health and Human Services Alex Azar, said one concern is that researchers are having difficulty studying the medial potential of marijuana because of the drug’s classification.”

Source: ChicagoSuntimes.com – December 6, 2018

DEA Releases 2018 National Drug Threat Assessment (NDTA)

November 12, 2018

“DEA Acting Administrator Uttam Dhillon today announced results of the 2018 National Drug Threat Assessment, which outlines the threats posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs.

Among the key 2018 NDTA findings:

Controlled prescription drugs remain responsible for the largest number of overdose deaths of any illicit drug class since 2001. These drugs are the second most commonly abused substance. Traffickers are now disguising other opioids as controlled prescription drugs to gain access to this market. (pages 1-10)

Heroin-related drug-poisoning deaths almost doubled between 2013 and 2016. This has been exacerbated by the increased adulteration of heroin with fentanyl and other synthetic opioids. Heroin available in U.S. markets is primarily sourced from Mexico, where opium poppy cultivation and heroin production have both increased significantly in recent years. (pages 11-20)

Of all opioids, the abuse of illicit fentanyl and other synthetic opioids has led to the greatest number of deaths in the United States. Fentanyl is increasingly available in the form of counterfeit prescription pills marketed for illicit street sales, and also sold by traffickers on its own, without the presence of other drugs. (pages 21-37)

The press release can be accessed at: https://www.dea.gov/press-releases/2018/11/02/dea-releases-2018-national-drug-threat-assessment-0

Source: DEA.gov – November 2, 2018

Senators Want Telemedicine Up Front In The Opioid Epidemic Battle

February 11, 2018

“A group of senators is urging the Trump Administration to allow healthcare providers to use telemedicine to tackle the nation’s ongoing opioid abuse epidemic.

In a letter to Robert W. Patterson, the acting administrator of the U.S. Drug Enforcement Agency, the senators have asked that the agency expedite the process allowing providers to register to prescribe medication-assisted treatments via telemedicine.

The severity of the U.S. opioid crisis demands nothing less than immediate action on this issue,” said the letter, dated January 30 and signed by Sens. Claire McCaskill (D-Mo.), Lisa Murkowski and Dan Sullivan, (both R-Alaska).”

Source: MHealthintelligence.com – February 6, 2018

Attorney General Sessions Announces DEA Surge to Combat Prescription Drug Diversion

February 11, 2018

“Attorney General Jeff Sessions announced yesterday that, over the next 45 days, the Drug Enforcement Administration (DEA) will surge Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs.

To intensify the fight against prescription drug diversion, DEA will utilize data from approximately 80 million transaction reports it collects every year from prescription drug manufacturers and distributors. DEA will aggregate and analyze this data, which includes distribution figures and inventory of prescription drugs, to identify patterns, trends, and statistical outliers that can be developed into targeting packages.

“Our country is in the midst of a drug abuse crisis, enabled and worsened by rampant drug trafficking and prescription drug diversion,” said Attorney General Jeff Sessions. “This surge of resources by the Drug Enforcement Administration will help us make more arrests, secure more convictions, and reduce the number of diverted or unnecessary prescription drugs causing addiction and overdose.”

Source: HuntingtonNews.net – January 31, 2018

AATOD Board Meeting Features Visits With Lawmakers, ONDCP, DEA, and SAMHSA

February 11, 2018

By Alison Knopf

The annual board meeting last December of the American Association for the Treatment of Opioid Dependence (AATOD) was more than just a meeting. Eight board members conducted a number of visits to Capitol Hill, educating Congressional representatives and staff. A key focus of these visits was getting reimbursement for Opioid Treatment Programs (OTPs) from Medicare Part B (which covers nonhospital treatment), said AATOD president Mark Parrino, MPA. “This will be a slow and labor-intensive process, but I believe that at the end, we will be successful,” Mr. Parrino told AT Forum.

The board also met with Richard Baum, MA, MPA, acting director of the Office of National Drug Control Policy (ONDCP); Demetra Ashley, MA, deputy assistant administrator for the Drug Enforcement Administration (DEA); Danielle Johnson Byrd, MPH, director of the Division of Pharmacologic Therapies at the Center for Substance Abuse Treatment (CSAT), Substance Abuse and Mental Health Services Administration; and Ms. Byrd’s staff. “They all led extremely productive discussions among AATOD board members,” said Mr. Parrino.

ONDCP

The ONDCP is expected to release the National Drug Control Strategy in March.

Speaking with the AATOD board, Mr. Baum, a longtime ONDCP official, continued to support the utilization of medication assisted treatment (MAT) for opioid use disorder (OUD), said Mr. Parrino. In addition to the use of medications, Mr. Baum stressed the need for offering comprehensive care services. “He expressed concern that treatment for opioid use disorder needs to reflect the best standards of care, so that we can be certain that patients are being properly treated when medications are selected by various treatment practitioners in the United States,” said Mr. Parrino. “ONDCP and its leadership continue to be supportive of the work of our Association and its members.”

Drug Enforcement Administration

The DEA officials who met with the AATOD board in December focused on three areas: mobile vans, telemedicine, and the new Narcotic Treatment Program Guidelines (NTP is the term the DEA uses).

Finalizing the mobile van policy development would certainly increase the use of mobile vans connected to the bricks-and-mortar OTPs, said Mr. Parrino. “We know that there are several states that want to purchase such vans so that they can expand the reach of OTPs in their areas.” For example, the Evergreen Treatment Services system in Seattle, Washington, is working in this area. In addition, the New York State Office of Alcoholism and Substance Abuse Services has indicated a strong interest in implementing mobile vans, especially in rural and upstate areas.

So, what is holding up the mobile vans issue? The DEA is interested in promulgating the rule, but is “running into some roadblocks regarding how fast they can introduce a new regulatory approach, at a time when deregulation seems to be the primary focus,” said Mr. Parrino. There will be more information at the conference in March when DEA leadership meets with the board of directors.

The release and implementation of the DEA’s new NTP guideline is being held back. The guideline discusses how mobile vans would be used, so it can’t be released until the mobile van policy is resolved.

AATOD is working with the American Academy of Addiction Psychiatry to develop telemedicine guidelines for OTPs. This matter will be discussed during the policy section of the March conference.

SAMHSA/CSAT

Danielle Johnson-Byrd and three of her associates led the discussion on how CSAT is targeting policies affecting OTPs in the United States. “We talked about the importance of proper OTP siting, especially as more treatment programs will be approved by CSAT to operate in the United States,” said Mr. Parrino.

There was also an in-depth discussion of the quality of care services offered through OTPs. CSAT reminded all board members that the agency will continue to promulgate effective oversight to be certain that OTPs follow existing standards, especially during a period of such rapid expansion.

The board also expressed concerns that states clearly demonstrate what they have done in using the grants from the State Targeted Response (STR) to the Opioid Crisis, issued by SAMHSA, for 2017. Are states using this money for MAT for OUDs? This is a matter of accountability, as states work to increase access to treatment; 80% of the STR grants had to be used for direct treatment for OUDs. But the board expressed concern that some states may be marginalizing the use of medications, such as methadone, or marginalizing OTPs themselves. For example, Wyoming decided not to use any STR grant funds for methadone maintenance treatment, and not to site any OTPs, Mr. Parrino noted.

“There are more encouraging reports from other states with regard to STR grant use, and it is expected that this will be reported on during the March conference in New York,” said Mr. Parrino. “There will be a number of policy discussions led by SAMHSA and CSAT representatives and it is certain this topic will come to surface.”

Sessions Steps Up Enforcement Actions in Opioid Crisis

December 11, 2017

“The Justice Department on Wednesday said it is stepping up enforcement efforts to combat the opioid crisis.

Attorney General Jeff Sessions announced that the agency will dedicate $12 million in grants to help police target illegal manufacturers and dealers of prescription opioids, heroin and methamphetamine.

The department is also directing U.S. attorneys around the country to designate an “opioid coordinator” for each office, and the Drug Enforcement Agency will open a new field division in Louisville to cover Kentucky, Tennessee and West Virginia, where communities have suffered particularly high rates of opioid addiction.

Source: USNews.com – November 29, 2017

How the DEA Changed the Overdose Numbers

October 31, 2017

US Department of Justice - Drug Enforcement Administration “The Drug Enforcement Administration has released its annual report on the threat posed to the U.S. by drug trafficking and the abuse of illicit drugs.

The 2017 National Drug Threat Assessment (NDTA) has both good and bad news about the nation’s worsening overdose crisis.

“The threat posed by controlled prescription drug (CPD) abuse is prevalent. Every year since 2001, CPDs, specifically opioid analgesics have been linked to the largest number of overdose deaths of any illicit drug class, outpacing those for cocaine and heroin combined,” the report declares.

That sure makes it sound like opioid pain medication is killing more people than ever before, doesn’t it? A closer look at the numbers and methodology used by the DEA suggests otherwise.

“Controlled prescription drugs” is a very broad category that includes not only opioid pain relievers, but anti-anxiety drugs (Valium, Xanax), stimulants (Adderall, Ritalin), and anabolic steroids. And there’s plenty of evidence people are dying from those drugs as well.

Source: PainNewsNetwork.org – October 25, 2017

See related DEA news: DEA establishes six new heroin enforcement teams available at: https://www.dea.gov/divisions/hq/2017/hq102717.shtml

Mobile Vans for OTPs: Getting Closer to Reality

August 11, 2017

By Alison Knopf

The Drug Enforcement Administration (DEA) is not yet ready to talk about mobile vans. The agency is likely to release new licensing regulations, which will open the door to more mobile vans to provide medication-assisted treatment for opioid use disorders—most likely in conjunction with brick-and-mortar opioid treatment programs (OTPs)—sometime this fall.

Demetra Ashley, associate deputy assistant administrator of the Office of Diversion Control of the DEA, told the board of the American Association for the Treatment of Opioid Dependence (AATOD) that the project was underway last year. However, it was last fall that she said that, and the situation hasn’t changed yet.

New Mobile Vans Need New Regulations

Existing mobile vans can still operate, but new ones need new regulations.

This affects many programs. For example, Washington State, as part of its CURES State Targeted Response to the Opioid Crisis (STR) grant, wants mobile vans. Evergreen Services in Seattle would buy two vans. “They have the CURES money, they have a designated provider, now they’re just waiting for the vans,” said Mark Parrino, MPA, AATOD president, in an interview. “But they can’t buy the vans until the DEA releases its new licensure standards. They’re ready to go, but they can’t.”

About four years ago the DEA decided not to license any new vans, but they did not de-license any existing vans. Once the new regulations are released, more mobile vans are expected to provide more treatment to more patients.

States Linked to OTPs via Mobile Methadone Vans

The following states have mobile methadone vans connected to OTPs (all data as of 2014):

California (3 vans/206 patients)
Massachusetts (3 vans, 2 being used on an active basis/150 patients)
Maryland (2 vans)
New Jersey (5 vans/1,000 patients)
Puerto Rico (2 vans)
Washington (1 van/175 patients)

Importantly, federal authorities need to be ready with a team of consultants who can help state authorities and providers comply with the new regulations.

Mr. Parrino doubts that the DEA would allow methadone to be dispensed from mobile vans that are not associated with brick-and-mortar OTPs. The reason is the storage rules for the medication.

The DEA’s proposal needs to be vetted through its main agency, the Department of Justice. In addition, every regulation must go through the Office of Management and Budget.

Number of OTPs Tops 1,500 For First Time Ever

June 2, 2017

By Alison Knopf

For the first time in the history of opioid treatment programs (OTPs)–federally regulated clinics that dispense methadone and other medications to treat opioid use disorders—there were more than 1,500 as of March, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).

“This is the first time it has gone past 1,500,” said Mark W. Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). “I believe there will be a steady rise in OTP numbers and patients in treatment, over the next several years,” Mr. Parrino told AT Forum. “SAMHSA is doing a great job in managing new OTP applications.”

AATOD has an ambitious plan—to reach 2,800 OTPs by 2020—announced at last fall’s meeting in Baltimore (see http://atforum.com/2016/12/aatod-conference-recap/).

As of December 23, 2016, there were 1,482 OTPs—up 66 from a year earlier (1,416), which was up 53 from December of 2014 (1,363) (see http://atforum.com/2017/02/aatods-goal-doubling-number-otps-strong-samhsa-support/).

Still, SAMHSA isn’t the only player. It’s up to other agencies—the state, the Drug Enforcement Administration (DEA), and of course local communities—to complete the process of certifying OTPs. This process can be long and time-consuming—and costly (see http://atforum.com/2016/04/success-story-advocate-opens-first-otp-second-opens-spring/). But in the end, communities benefit.

And that may be another reason that the OTPs are increasing in number: communities may finally be overcoming their NIMBY (“not in my backyard”) fears. “The rate of growth of opioid treatment programs has traditionally been slow,” Melinda Campopiano, MD, chief of SAMHA’s Division of Pharmacological Therapies, told AT Forum. “This expansion in programs, approximately 100 in the last year, may indicate that communities and providers are recognizing the utility of the model, and acceptance of pharmacotherapy for opioid use disorders is increasing.”