DEA – The Health Care Blog https://thehealthcareblog.com Everything you always wanted to know about the Health Care system. But were afraid to ask. Tue, 05 Dec 2023 21:51:57 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.4 The Courage of Corporate America is Needed to End America’s Opioid Crisis https://thehealthcareblog.com/blog/2023/12/11/the-courage-of-corporate-america-is-needed-to-end-americas-opioid-crisis/ Mon, 11 Dec 2023 06:06:00 +0000 https://thehealthcareblog.com/?p=107726 Continue reading...]]>

By RYAN HAMPTON

A Kaiser Family Foundation tracking poll published in July found that three in ten U.S. adults (29%) said they had someone in their family who struggled with opioid dependence. Also surprising, and encouraging, was the statistic that 90% support increasing access to opioid use disorder treatment programs in their communities.

As a person in recovery from opioid use disorder and advocate, my read on this data set is that the public support is there. Now more than ever, we need leaders in healthcare, public policy, and corporate America to have the courage to advance effective treatment options. The most inspiring example of the kind of courage we need was the recent news that one of the nation’s largest retail grocery and pharmacy chains, Albertsons, made the financial investment to train their pharmacy staff to administer buprenorphine injections (known as Sublocade) on site.

To someone who is not in the weeds on the issue of opioid use disorder (OUD) treatment programs, this may just sound like a solid business decision. But go a layer deeper and the courage is evident: Albertsons decided to invest in an underutilized treatment option (despite buprenorphine being the gold-standard in OUD treatment) that serves a highly stigmatized patient population who is often shunned at pharmacy counters nationwide. Albertsons chose to put treatment centers for an underserved and highly stigmatized patient population in the middle of their family-friendly, neighborhood grocery pharmacy chain. 

The company rightly recognized that OUD impacts every family and community in this country—including the lives of its patrons. Albertsons pushed through stigma, not leaving the overdose crisis for someone else to address, because it had the ability to provide widespread access through its pharmacies and locations across the nation.

This kind of principled leadership at the corporate level is truly inspiring.

Investing in Solutions is Critical to Ending OUD

It’s easy to say we want to do the right thing, but it takes courage to actually do it. And though many of Albertsons’ customers surely know someone affected by OUD, they (like most people) don’t have a true understanding of the disorder. Without courage, that ignorance will affect our country’s ability to end this health crisis.

When I talk to people about what I do, most are shocked to learn basic facts about opioid use disorder (OUD). For example, few people know that one-in-three people with OUD were exposed to opioids through a legal prescription for pain from their doctor.

Most assume this problem is isolated to the unhoused and people in custody, when in fact more than half of people are employed, in school or full-time parents. And, sadly, too few people know—including those who suffer from OUD—that the disorder can be treated effectively with medication in an outpatient or virtual setting, for less than $500 a month, including the cost of medication.

When I lay out the facts, that OUD impacts a diverse group of Americans, that there’s an effective and affordable way to treat it that’s accessible on an outpatient basis—the next obvious question is, why aren’t we doing more?

My answer is: we lack courage. Without courage, companies would not mobilize recovery, like Albertsons did, and investors would not back start-ups that are trying to tackle this problem. 

For investors, it’s certainly much safer to bet on companies with a clear path to high returns: especially in the healthcare space. We see this all the time when venture capital makes big bets on established players. But people who fund treatment programs that focus on the most vulnerable—and least powerful—in our society exemplify the kind of courage I am talking about.

In recent years, this courage has paid off. Over the last three years, venture capitalists have invested in companies to help scale telehealth treatment programs for OUD—effectively reaching thousands of patients across many states. These programs have impressive, peer-reviewed, clinical outcomes, and these models are repeatable and effective.

The only reason programs like this are not available in all 50 states is because regulators lack the courage to act. Many state and federal regulators who were eager to embrace telehealth during the pandemic have been slow to make these changes permanent, despite the overwhelming evidence that telehealth is an effective way to deliver treatment for OUD, and that traditional treatment programs are not able to meet the needs of all patients.

Certainly, office-based opioid treatment (OBOT) programs have a role to play in addressing the crisis, but they can’t do it alone. This fact was on full display in states like Alabama and Michigan over the last few years. 

In 2022, Alabama arbitrarily reinstated an annual in-person visit requirement for patients with OUD. With no clinicians living in the state, tele-MOUD companies quickly stopped accepting new patients and eventually had to fly physicians to the state to see patients in-person, so those patients could stay in treatment. A year later, Michigan erected enormous barriers to tele-MOUD services for low-income patients on Medicaid. A legislature that prevents its most vulnerable citizens from accessing affordable, convenient and effective healthcare, should question its priorities and face the wrath of voters.

The Uncertain Future of Virtual Care

Even though telehealth treatment for OUD was implemented out of necessity during the pandemic, there’s no doubt it works. According to one study of Medicaid data, initiating treatment of buprenorphine for OUD through telehealth—versus in-person—increased the likelihood of patient retention. And people living in care deserts were finally able to access treatment for OUD perhaps for the first time thanks to telehealth expansion during COVID-19.

As of a few weeks ago, the Drug Enforcement Administration (DEA) has decided to temporarily extend COVID-era telehealth prescribing flexibilities through the end of 2024. While this is a sign that pleas from patients and providers are being heard, it’s still only temporary. What happens after 2024? What happens when states enact their own, stricter policies?

Accepting telehealth as a viable form of OUD treatment at the state and federal levels not just for now, but for the future, is an imperative and courageous step policymakers must take in order to quell growing OUD statistics. 

In recent weeks, a bipartisan group of Senators re-introduced a bill (The TREATS Act which was initially introduced in 2020) which will increase access to telehealth services for OUD, effectively keeping the COVID-era regulations in place. There is no medical evidence to support the requirement for an in-person exam for OUD because a clinician is not required to physically examine a patient in order to make that diagnosis.

Courage begins with the willingness to listen and to reason. The DEA and the law makers behind the TREATS Act have exhibited that. After a major backlash to the DEA’s proposed rules released in February, they’ve taken a reasoned, courageous approach to updating the regulatory environment that is in the best interests of patient care. 

The overdose crisis is a complex problem, but it is one that we can solve. We need to summon the courage to take action. We need to invest in new and innovative models for providing medication-assisted treatment. And we need to urge the DEA and Congress to make it easier for people to get the treatment they need.

Ryan Hampton is an addiction recovery advocate and person in recovery. He was previously an official in the Clinton Administration. His most recent book is Unsettled: How the Purdue Pharma Bankruptcy Failed the Victims of the American Overdose Crisis.

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Stephanie Strong, CEO, Boulder https://thehealthcareblog.com/blog/2023/12/04/stephanie-strong-ceo-boulder/ Mon, 04 Dec 2023 04:52:35 +0000 https://thehealthcareblog.com/?p=107703 Continue reading...]]> Stephanie Strong is the CEO of Boulder, which has been blazing a trail in the virtual treatment of substance use disorder. She left venture capital to start the company and has been steadily building its capabilities and reach. We talked in depth about how Boulder helps its patients, who are predominantly on Medicaid and in general tend–as you’d expect–not to have easy circumstances. One remarkable thing Stephanie has done is spearhead resistance to the DEA’s proposal to ban telehealth prescribing of the anti-addiction drug Buprenorphine. And it looks like that campaign has been successful. that alone will save many lives. Watch this interview of a young female CEO who is making a real difference, and totally impressing me in the processMatthew Holt

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Matthew’s health care tidbits: Oh, the DEA makes me sigh…. https://thehealthcareblog.com/blog/2023/03/07/matthews-health-care-tidbits-oh-the-dea-makes-me-sigh/ Tue, 07 Mar 2023 09:06:00 +0000 https://thehealthcareblog.com/?p=106804 Continue reading...]]> Each time I send out the THCB Reader, our newsletter that summarizes the best of THCB (Sign up here!) I include a brief tidbits section. Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

I have always thought that the dual role of the Drug Enforcement Agency (DEA) was an anachronism that severely hampers America’s complex relationship with pharmaceuticals. Congress deems some medicines legal and regulates them via the FDA, and deems others illegal and tells the DEA and other law enforcement agencies to attempt to control their supply. Leaving aside the basic futility of this task, somehow DEA was also given the task of regulating the prescribers of legal prescription (and non-prescription) drugs–in particular those around controlled substances.

This has led to decades of DEA-led persecution of doctorspatients and even convenience store clerks in the name of reducing the diversion of opiates and methamphetamines. Of course going after any of these folks is much easier and less risky than hunting a Mexican cartel or busting real criminals, so it’s easy to see why the DEA has taken that approach. Has it worked in reducing the supply of opiates? Maybe. Has it had any impact on the opiate crisis? Not really. Have a whole lot of patients been caught in the crossfire? Yup.

Now the DEA is moving onto the next phase–re-regulating the online prescribing of controlled substances that was liberalized at the start of the public health emergency in 2020. As you can imagine, their proposals are not exactly bursting with reason.

The DEA is essentially banning all controlled prescribing without a face to face visit first. This is despite the fact that the demand for those mental health medications increased dramatically during the pandemic as rates of depression and anxiety went up by a factor of three. While you can argue that in 2021 and 2022 some online services (notably Cerebral) may–and I stress may–have crossed the over-prescribing line for ADHD and other conditions, there’s no evidence that what happened is any worse than the in-person care that the DEA has been inadequately overseeing for decades. More importantly, those online services have already pulled out of those exact therapeutic markets the DEA is alarmed about. Who is left providing online ADHD care? Local clinicians and reputable services. And of course DEA knows full well, and is doing nothing about, the lack of access to mental health professionals that existed long before the increase in demand.

Is there any reason to suspect DEA will improve the quality of the system dealing with these medications? Highly doubtful. There are two current examples suggesting why not. First, due to the increased demand from the pandemic induced mental-health crisis and production problems at pharma company Teva, there’s a massive shortage of ADHD medication already. The DEA could help patients out here, but have declined to increase production quotas–sending millions of patients and their parents on a wild goose chase hunting down pharmacies with actual supply of Adderall and related meds.

Secondly, the DEA wants to also ban the the online prescribing of another drug, buprenorphine, which is used to help wean patients with substance use disorder off opiates and other substances. OK, so there’s a one month grace period here but essentially this is a short-sighted ban that will directly lead to patients going to the black market to acquire opiates, leading to more addiction and death.

My conclusion is that the DEA should be removed from its oversight of licensed clinicians and that role be given to FDA or HHS. At the least these proposed  regulations should be abandoned and rolled back to what we have now. The only good news is that there is still time to comment on the regulations. I went and did so and I hope you will too. Patients have suffered enough already.

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