Talbott,patient advocate and OTP owner,leaves BayMark

Zac Talbott's last day with BayMark Health Services, which bought his opioid treatment programs (OTPs), Counseling Solutions Treatment Centers, in Chatsworth, Georgia, and Brasstown, North Carolina, last year (see “From starter OTP to acquisition by BayMark: A 3‐year journey,” ADAW, Sept. 8, 2018, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32095 ), was May 24. He had various options and opportunities that could have resulted in him leaving earlier, but he did not want to leave in the midst of so much change. He opened the first Counseling Solutions clinic in 2015 (see “Methadone patient and advocate to open own OTP in Georgia,” ADAW, Aug. 17, 2015, https://onlinelibrary.wiley.com/doi/10.1002/adaw.30292 ).     

Shatterproof on its rating pilot for SUD treatment programs

Shatterproof launched its rating system for addiction treatment programs with a $5 million pilot, the company announced in December, with funding coming mainly from insurance companies and grants (see ADAW, Jan. 14). The project began a year ago (see ADAW, Jan. 15, 2018) but is now moving forward. ADAW caught up with Sam Arsenault, director of national treatment quality initiatives for Shatterproof, last week about the project.     

Onslaught against 42 CFR Part 2 continues in Congress

With the opposition of the American Medical Association (AMA) last fall, any moves in Congress and the federal government to weaken the patient consent provisions of 42 CFR Part 2, the regulation protecting the confidentiality of substance use disorder (SUD) treatment records, were stopped in their tracks — and in the nick of time (see ADAW, Oct. 1, 2018; Oct. 15, 2018). But the groups promoting the complete abandonment of 42 CFR Part 2, replacing it with the Health Insurance Portability and Accountability Act, which itself is targeted for at least partial destruction (see ADAW, Jan. 21, Jan. 28, Feb. 25), are back. There's a new push to try to overhaul 42 CFR Part 2.     

AAC statement on NAATP lawsuit

As the National Association of Addiction Treatment Providers (NAATP) was beginning its annual leadership meeting May 6, American Addiction Centers sued the organization in federal court (see “AAC sues NAATP for defamation,” ADAW, May 13, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32362 ). We wanted to provide further information on the lawsuit (which we linked to in our story last week). Below is a statement provided exclusively to ADAW by AAC May 15.     

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.”     

Clarification on Braeburn's CAM2038/Brixadi/Buvidal

In our recent article “Sublocade: Why a placebo arm?” (see ADAW, March 11), we referred to the investigational medication CAM2038, an injectable (weekly subcutaneous depot) form of buprenorphine that is competing with Sublocade in the buprenorphine market. To make the terminology clear, the name of the investigational medication, developed by Braeburn in partnership with Camurus (Braeburn's European partner), is Brixadi. In Europe and Australia, however, the product is approved and marketed by Camurus under the trade name Buvidal. The Food and Drug Administration (FDA) granted tentative approval to Brixadi in December 2018, but Sublocade has exclusivity. “Brixadi's clinical development program was designed with input from the FDA,” said Sonnie Kim, Pharm.D., Braeburn vice president and head of medical affairs, in an email to ADAW. CAM2038 was found effective in Phase 2 research (see ADAW, June 26, 2017). The most recent results were published in JAMA Internal Medicine ( https://jamanetwork.com/journals/jamainternalmedicine/article‐abstract/2681061 ). We regret any confusion. For more information, go to www.braeburnrx.com .     

NAATP to court: AAC doesn't have a case

Citing “actions that it had every right to take, statements of opinion it had every right to make, and the actions and the conduct of third parties” for which it had no control or responsibility, the National Association of Addiction Treatment Providers (NAATP) filed a motion to dismiss the complaint against it by American Addiction Centers (AAC) filed in May (see ADAW, May 13, May 20).     

As HIPAA changes loom,patients demand continued confidentiality for SUD records

In last week's issue, we wrote about the plans by the federal Department of Health and Human Services (HHS) to weaken the Health Insurance Portability and Accountability Act (HIPAA), citing regulatory burdens and the need for information‐sharing (see ADAW, Jan. 21). The plans, detailed in a request for information (RFI) issued Dec. 12, throw a wrench into the plans by the “make 42 CFR Part 2 like HIPAA” movement, which would erase the federal confidentiality regulation protecting substance use disorder (SUD) treatment records by watering it down to HIPAA standards. Now, with even HIPAA seeming too burdensome, the need is even greater to protect the consent provision of 42 CFR Part 2 — which is basically all that's left after the Substance Abuse and Mental Health Services Administration (SAMHSA) allowed information‐sharing for the vague “health care operations” without consent last year (see ADAW, Jan. 8, 2018). Last week, H. Westley Clark, M.D., J.D., dean's executive professor at Santa Clara University and former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, made this abundantly clear in his comments to ADAW.     

When pricing treatment,know your costs and set your profit margins

Billing, ethics and parity have been hot‐button issues for substance use disorder (SUD) treatment centers for years, but the National Association of Addiction Treatment Providers (NAATP) is getting closer to finding solutions. At its annual leadership meeting in Washington last month, members, not to be deterred by a surprise lawsuit on opening day from American Addiction Centers (see ADAW, May 20, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32368 ), gathered to hear from experts on how to properly conduct billing in a dynamic new environment.     

‘Hogwash’: Addiction Policy Foundation on opioid bill reports

Last week, as the Senate headed toward a vote on the opioid package, the Addiction Policy Forum was weathering an attack in the form of almost identical stories in Congressional Quarterly and Politico that said Democrats were opposed to a provision in the bill that favors the advocacy organization. According to both reports, which came out Sept. 5, Democrats objected to the language that would give $10 million a year for five years to an advocacy organization, language that would apply only to the Addiction Policy Forum. The unnamed Democrat staffers, according to the stories, pinned their criticism on the fact that the Addiction Policy Forum receives pharmaceutical funding, something the organization itself announced last December (see ADAW, Jan. 8) but created a minor ruckus after protesters from Minnesota accused the group of a conflict of interest in a story published in The New York Times (see ADAW, Feb. 19, 2018).     

Methadone and buprenorphine in prison: Success in RI

The omnipresence of substance use disorder in prisons and jails cries out for treatment — and so do the inmates — but until recently, it has been scarce. Leading the way is the small state of Rhode Island, where Cranston‐based CODAC, an opioid treatment program (OTP), is providing methadone inside the state's jail/prison facility, with staff working alongside corrections (see ADAW, May 7, 2018).     

From starter OTP to acquisition by BayMark: A 3‐year journey

BayMark Health Services has acquired Counseling Solutions, a treatment provider focusing on methadone and buprenorphine treatment with locations in Chatsworth, Georgia, and Brasstown, North Carolina. When Zachary Talbott first started working to open his opioid treatment program (OTP) in Chatsworth more than three years ago, he had no plans to sell it (see ADAW, Aug. 17, 2015).     

AMA and ASAM have different views on SAMHSA NPRM

The comment period for the notice of proposed rulemaking (NPRM) that would allow law enforcement to have access to all patient records if it is investigating an alleged serious crime by a patient (see ADAW, Sept. 9) closed Sept. 25. There was no extension, as some (including the American Medical Association [AMA]) had requested (see ADAW, Sept. 23). This proposal, by the Substance Abuse and Mental Health Services Administration (SAMHSA), would alter 42 CFR Part 2 by allowing this access, also changing the definition of serious crime to include anything related to drug trafficking.     

Sublocade: Why a placebo arm?

In a time when people are dying from illicit fentanyl overdoses, why would a trial for a new medication to treat opioid use disorder — a formulation of buprenorphine, already proven to be safe and effective in oral form — include a placebo arm? This was the question asked by many when the results of Indivior's trial for Sublocade, a buprenorphine injection that lasts a month, were published last month in The Lancet (see ADAW, Feb. 25). The trial results were what led to Sublocade's approval by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017).     

AUD medications and postsurgery opioids: The latest

Topiramate's use as a treatment for alcohol use disorder (AUD) is not a new idea, Bankole Johnson, M.D. (now of ondansetron fame; see ADAW, March 25, April 1), reviewed it many times (see ADAW, Oct. 15, 2007; Feb. 11, 2008; June 16, 2008; Nov. 3, 2008; June 7, 2010; Jan. 31, 2011; Feb. 24, 2014). But a comprehensive review published recently in the Journal of Addiction Medicine is concise. While not approved by the Food and Drug Administration for AUD, topiramate can be prescribed off‐label, and should be considered as a treatment for the condition, according to Ajay Manhapra, M.D., and colleagues in the article, “Topiramate Pharmacotherapy for Alcohol Use Disorder and Other Addictions: A Narrative Review.” Like ondansetron and other possible AUD medications, including those that are approved (like acamprosate and naltrexone), topiramate doesn't work for everyone. But pharmacogenetic testing may help identify those who are likely to respond, according to the review. In addition, there are early studies indicating it could be used to treat cocaine and nicotine use disorder, as well as behavioral addictions.     

Study finds MAT combined with 12‐Step residential treatment is effective

To those who might assume a federal lawsuit seeking class status for treatment providers wronged by insurance company actions would be receiving immediate and universal acclaim in the provider community, a little caution may be in order. While the latest lawsuit against United Behavioral Health (UBH) certainly will be interpreted by some addiction treatment providers as an opportunity to recover payments that were inappropriately denied (see ADAW, Sept. 23), the case also could launch a broader discussion of how best to guarantee that insured patients receive the care to which they are entitled.     

ADA settlement exposes liability when providers refuse MAT patients

Gov. Andrew Cuomo of New York has added opioid use disorders (OUDs) to the list of approved conditions for which medical marijuana could be prescribed in the state, following the lead last month of New Jersey Gov. Phil Murphy, who limited such use as an “adjunct” to medications like methadone and buprenorphine (see ADAW, Jan. 28).     

Sublocade trial data published: Better than placebo

Sublocade, a buprenorphine injection that lasts a month, was approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017), but the data that led to the approval was not public. It was made public in an article by Sublocade manufacturer Indivior published Feb. 18 in The Lancet.     

SAMHSA to write new application for new SOR with stimulants included

The addition of stimulants as an allowable use for State Opioid Response (SOR) grants will require a new application, which the Substance Abuse and Mental Health Services Administration (SAMHSA) is working on, ADAW has learned. The change was in the FY 2020 appropriations bill passed last month by Congress (see ADAW, Dec. 23, 2019; “FY 2020 Appropriations: Stimulants added to SOR's $1.5 billion,” https://onlinelibrary.wiley.com/doi/10.1002/adaw.32573 ), along with funding for other SAMHSA programs, including the Substance Abuse Prevention and Treatment block grant (SAPT BG). After the bill passed before Christmas, Washington went away for the holidays.