Treatment Archives - Page 8 of 21

March 3, 2023

Operators of Addiction Treatment Chain Charged in Alleged Health Care Fraud | USAO-RI

PROVIDENCE – The Massachusetts operator of a chain of habit procedure clinics is billed in federal court docket in Providence, RI, with thousands and thousands of pounds of well being care fraud, aggravated identity theft, revenue laundering and obstruction, declared United States Lawyer Zachary A. Cunha. In addition, the cure centre and its former supervisory counselor were also charged with overall health treatment fraud.

Michael Brier, 60, of Newton, MA, Mi Ok Bruining, 62, of Warwick, RI, and Recovery Connections Centers of America, Inc. (RCCA) are billed by criminal grievance with wellbeing care fraud. Michael Brier was also billed in the complaint with aggravated identity theft, income laundering and obstruction.

It is alleged in court paperwork that, Brier, Bruining, and RCCA shortchanged Rhode Island and Massachusetts compound abuse dysfunction sufferers out of significantly essential counseling and treatment method solutions, when defrauding Medicare, Medicaid, and other health insurers out of thousands and thousands of pounds.

At a push conference asserting the culmination of this investigation and ensuing prison prices and arrests, United States Attorney Zachary A. Cunha commented, “What makes the fraud plan that we have billed today significantly pernicious – is that not only was this plan, as we allege, intended to defraud by enriching these defendants with federal and personal health care dollars they did not gain, but that in the method it cheated a susceptible population of recovery sufferers out of the whole, legitimate assistance and treatment that they have to have to have a probability at restoration.”

“Today’s arrests serve as a potent reminder that we will not tolerate fraud techniques that goal our federal health treatment applications, as alleged, nor will we settle for anything much less than higher excellent care for the men and women served by those programs,” said Unique Agent in Demand Phillip M. Coyne of the U.S. Division of Wellbeing and Human Products and services, Business of Inspector Typical. “Our agency’s mission is to shield the perfectly-becoming of the public and the integrity of the federal wellness treatment technique, and we will hold accountable people who seek to exploit the opioid epidemic for personalized obtain.”

“Today, we arrested and charged Michael Brier, Mi Okay Bruining, and Restoration Connections Centers of America, for a large-ranging plan in which they are accused of abusing our well being treatment procedure, cheating taxpayers, and leveraging the opioid disaster to consider benefit of these battling with substance abuse so the firm could rake in millions,” claimed Joseph R. Bonavolonta, Special Agent in Cost of the FBI Boston Division. “The allegations set forth in this scenario stand for just one of the most brazen and egregious illustrations of health treatment fraud the FBI has found here in Rhode Island in recent history, and make no miscalculation, it is not a victimless crime. Anytime the integrity of our federal wellness care plans is undermined, we all spend the value by way of the expense of better coverage rates, increased out-of-pocket fees, and co-pays, and even decreased or misplaced rewards.”

According to the charging documents, Brier, Bruining and RCCA operated a chain of addiction cure centers but unsuccessful to supply the sufferers with the expected counseling classes and cure, even though simultaneous billing Medicare, Medicaid and other health care payors for 45-moment counseling classes on a schedule foundation even although the periods ended up not a lot more than 15 minutes, and often only 5-10 minutes or fewer. At situations, so numerous counseling periods were being billed at this amount that the total total of time would be difficult for the accessible therapist to have supplied in any 24 hrs time period.

Brier and RCCA are also alleged to have triggered a fraudulent software to be submitted to Medicare which, between other matters, misrepresented and concealed the role that Brier was participating in in the organization and unsuccessful to disclose Brier’s 2013 criminal conviction for federal tax crimes, which was related to Medicare’s thing to consider of the software.

The Complaint also alleges that Brier purported to exercise drugs and wrote and prompted to be filled fraudulent prescriptions working with the names and prescriber details, including Drug Enforcement Administration figures, of health professionals with out their permission.

Brier is also alleged to have falsified a doc in a issue in the jurisdiction of an company of the United States by causing the Healthcare Director to indicator a false and again-dated document.

The complaint alleges that defendants brought on hundreds of thousands of pounds in fraudulent billings to be submitted to Medicare and millions much more in fraudulent billings to other health and fitness treatment payors.

The govt is also looking for to forfeit thirteen bank accounts, two buildings, and two automobiles allegedly understood by the defendants as a result of the alleged criminal carry out.

A federal legal grievance is simply an accusation. A defendant is presumed harmless until and till proven guilty.

The case is getting prosecuted by Assistant United States Lawyers Sara Miron Bloom and Kevin Love Hubbard.

The matter was investigated by the U.S. Division of Wellness and Human Solutions, Workplace of Inspector General and the Federal Bureau of Investigation. United States Legal professional Cunha thanks the IRS, Customs and Border Protection, and the Rhode Island Business of the Legal professional Basic for their guidance in the investigation.

Also, United States Legal professional Cunha many thanks the United States Office of Overall health and Human Services and the Centers for Sickness Regulate, and their partners in Rhode Island and Massachusetts, for their brief response to build services for people who may well be impacted by this regulation enforcement action.

On top of that, United States Legal professional Cunha many thanks the United States Department of Overall health and Human Solutions Centers for Disease Management and Prevention’s Opioid Swift Reaction System, and their partners in Rhode Island Division of Behavioral Healthcare and Massachusetts Section of Community Wellness, for assisting sufferers who could be impacted by this law enforcement action.

Rhode Island Department of Behavioral Healthcare, Developmental Disabilities and Hospitals is performing to assure continuity of therapy for RCCA people. Rhode Island patients in have to have of a new or quick bridge prescription are urged to call (401) 606-5454 Rhode Island individuals in need to have of behavioral overall health referrals for physicians, counselor, or clinic details may well phone (410) 414-Url.

Massachusetts Department of Community Health, Bureau of Material Habit Services is performing to assure continuity of care and procedure RCCA people. Massachusetts sufferers in have to have of a new or immediate bridge prescription are urged to contact (617) 414-4175 Massachusetts patients in need to have of behavioral well being referrals for physicians, counselor, or other providers could get in touch with (800) 327-5050 or use helplinema.com.

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March 1, 2023

FDA Approves Omaveloxolone As First Treatment for Friedreich Ataxia

Susan Perlman, MD, clinical professor of neurology at the David Geffen School of Medicine of UCLA

The FDA has approved omaveloxolone (Skyclarys), an agent developed by Reata Pharmaceuticals for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older, making it the first and only therapy approved for the indication.¹

In the supporting trial data, treatment with omaveloxolone resulted in statistically significant lower modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo at Week 48, accounting for a placebo-corrected difference between the groups of –2.41 points (P = .0138). The therapy, an oral once-daily medication, is indicated with a recommended dose of 150 mg (taken in 3 capsules).

Notably, the treatment label indicates a recommended dosage of 100 mg once daily for individuals with moderate hepatic impairment, to be further reduced to 50 mg once daily in the instance of adverse reactions. For those with severe hepatic impairment, the treatment is not recommended.²The label also indicates that alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, B-type natriuretic peptide (BNP), and lipid parameters should be obtains prior toand during treatment.

Friedreich ataxia is a disorder that has lacked treatments for some time, presenting a clinical challenge for physicians and patients alike. The agency’s decision to approve omaveloxolone was supported by the efficacy and safety data from the MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe extension trial (NCT02255435).

“Friedreich’s ataxia is a debilitating neuromuscular disease that progressively robs patients of their mobility and independence,” Susan Perlman, MD, clinical professor of neurology at the David Geffen School of Medicine of UCLA, said in a statement.¹ “The approval of SKYCLARYS represents an important step forward in the treatment of Friedreich’s ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease.”

Warren Huff, CEO of Reata, said in a statement that the approval was “an important milestone for patients affected by this disease as well as their families and caregivers.” He continued, adding, “We are grateful to Friedreich’s ataxia patients, investigators, US regulators, and our scientists and employees who made this approval possible. As a company, this is a transformative milestone that highlights our commitment to developing and commercializing novel therapies for patients with severe diseases with few or no approved therapies. We look forward to delivering Skyclarys to eligible patients as quickly as possible.”¹

Friedreich Ataxia Fast Facts

Friedreich ataxia is an inherited disease that is caused by a mutation in the FXN gene, which encodes for the frataxin protein. The disease is inherited in an autosomal recessive manner, meaning that an individual must inherit 2 copies of the mutated gene, 1 from each parent, to develop the disease.
Friedreich ataxia primarily affects the nervous system, causing progressive damage to the spinal cord and peripheral nerves. Symptoms can include problems with balance and coordination, muscle weakness, and loss of sensation in the arms and legs.
The onset of Friedreich ataxia typically occurs in childhood or adolescence, although in rare cases, symptoms may not appear until adulthood.
Patients with Friedreich ataxia are at an increased risk of developing cardiomyopathy, a condition where the heart muscle becomes weakened and enlarged. Patients may also experience vision and hearing problems, scoliosis, and diabetes mellitus.
Genetic counseling is recommended for families affected by Friedreich ataxia to help them understand the inheritance pattern of the disease.

READ MORE: Assessing the Recent Progress in ALS at MDA 2023

Omaveloxolone previously received fast track designation and a rare pediatric disease designation from the FDA. Reata’s new drug application (NDA) for omaveloxolone was submitted and accepted for review in May 2022. The agency pushed the review back several months after Reata submitted additional data from the updated delayed-start analysis from the phase 2 MOXIe extension study that featured a data cut-off of March 2022, as well as a new propensity-matched analysis of the findings using patient data from the Clinical Outcome Measures in Friedreich’s Ataxia Study, and an analysis of the relevance of omaveloxolone’s target pathway, Nrf2.^3,4

The company had submitted these data after a midcycle communication meeting with the FDA, at which time the agency raised concerns about the NDA. The resulting changes warranted a major amendment, prompting the extension.

At the time, Huff said in a statement, “We are pleased with the FDA’s decision to review the new information we recently provided to the Division. We remain committed to our goal of working with the FDA to secure regulatory approval for omaveloxolone as quickly as possible for patients with this severe disease that has no approved therapies.”³

In the originally published dataset from David R. Lynch, MD, PhD, professor of neurology at the University of Pennsylvania Perelman School of Medicine, and colleagues, 103 patients were randomly assigned to receive omaveloxolone (n = 51) or placebo (n = 52).⁵ The changes from baseline in mFARS scores in the omaveloxolone group (–1.55 points; SD, 0.69) and placebo group (0.85 points; SD, 0.64) showed a significant between-group difference of –2.40 points (SD, 0.96; P = .014). Additionally, transient reversible increases in aminotransferase levels were observed with omaveloxolone without increases in total bilirubin or other signs of liver injury.

In September 2021, Lynch told NeurologyLive^®, “Theoretically, it should have some benefit on all aspects of the disease, and perhaps more importantly, for at least some period of time [it can] slow the progression, which is what the delayed-start study showed.” The following March, at the 2022 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, March 13-16, in Nashville, Tennessee, findings from that delayed-start period of the MOXIe extension study were presented by Sub H. Subramony, MD, professor of neurology at the University of Florida College of Medicine, that supported the positive primary end point findings from part 2 of the pivotal MOXIe trial.⁶

In that presentation at MDA, data showed that when comparing mFARS scores between both groups, investigators found that the difference at the end of the placebo-controlled MOXIe Part 2 study, which was –2.25 points (SD, 1.07; P = .037), was preserved at the conclusion of the delayed-start period, at –3.51 points (SD, 1.45; P = .016). In the open-label extension, the annualized mFARS slope for patients in the placebo-to-omaveloxolone group was 0.45 points (SD, 0.38), which was similar to the omaveloxolone-to-omaveloxolone group, at 0.27 points (SD, 0.59). Investigators noted that both slopes were less than the expected +1.9 points per year that had been observed in natural history data. For patients in the omaveloxolone-to-omaveloxolone group, they continued to show no worsening in mFARS scores when compared with their original baseline score through 120 weeks of treatment.

In addition to the news that the FDA had granted approval to the therapy, Reata announced the launch of its specialty pharmacy and patient services program, called REACH (Reata Education, Access, and Care Helpline). Those looking for additional information about the program can call 1-844-98-REACH or visit www.reataREACH.com.¹

REFERENCES
1. Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia. Reata Pharmaceuticals. News release. February 28, 2023. Accessed February 28, 2023. https://www.reatapharma.com/investors/news/news-details/2023/Reata-Pharmaceuticals-Announces-FDA-Approval-of-SKYCLARYS-Omavaloxolone-the-First-and-Only-Drug-Indicated-for-Patients-with-Friedreichs-Ataxia/default.aspx
2. SKYCLARYS. FDA Label. Updated February 28, 2023. Accessed February 28, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216718Orig1s000lbl.pdf
3. Reata Pharmaceuticals Announces Three Month Extension of the Review Period for New Drug Application for Omaveloxolone for the Treatment of Friedreich’s Ataxia. News release. Reata Pharmaceuticals. August 9, 2022. Accessed February 28, 2023. https://www.businesswire.com/news/home/20220809005508/en/Reata-Pharmaceuticals-Announces-Three-Month-Extension-of-the-Review-Period-for-New-Drug-Application-for-Omaveloxolone-for-the-Treatment-of-Friedreich{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc}E2{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc}80{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc}99s-Ataxia
4. Reata Pharmaceuticals Announces FDA Filing Acceptance and Priority Review Designation for the NDA for Omaveloxolone for the Treatment of Patients with Friedreich’s Ataxia. News release. Reata Pharmaceuticals. May 26, 2022. Accessed February 28, 2023. https://www.reatapharma.com/investors/news/news-details/2022/Reata-Pharmaceuticals-Announces-FDA-Filing-Acceptance-and-Priority-Review-Designation-for-the-NDA-for-Omaveloxolone-for-the-Treatment-of-Patients-with-Friedreichs-Ataxia/default.aspx
5. Lynch DR, Chin MP, Delatycki MB, et al. Safety and Efficacy of Omaveloxolone in Friedreich Ataxia (MOXIe Study). Ann Neurol. 2021;89(2):212-225. doi:10.1002/ana.25934
6. Subramony SH, Boesch S, Chin M, et al. Efficacy of omaveloxolone in patients with Friedrich’s ataxia: update of the delayed-start study. Presented at MDA Clinical and Scientific Conference; March 13-16, in Nashville, TN and Virtual. Poster 55.

February 28, 2023

Sen. Fetterman still in treatment, staying up on Senate business

Sen. Fetterman’s communications director presents health update

Sen. Fetterman’s communications director provides overall health update

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HARRISBURG, Pa. (CBS) — Pennsylvania Sen. John Fetterman remains in the medical center to get therapy for medical depression but is keeping up to date on Senate organization, his communications director Joe Calvello stated in a assertion Monday.

Fetterman checked himself into Walter Reed National Armed forces Clinical Centre on Feb. 15 to get cure.

“John is carrying out effectively, performing with the wonderful doctors, and continues to be on a path to recovery,” Calvello stated. “He is visiting with employees and family members each day, and his staff are retaining him up-to-date on Senate business and information. Our group is transferring entire pace ahead and working tirelessly for the men and women of Pennsylvania. Just last 7 days we opened a new place of work in Erie and will be opening a number of additional places of work in the coming weeks.”

“We comprehend the extreme desire in John’s standing and in particular respect the flood of nicely-needs,” Calvello extra. “Having said that, as we have reported this will be a weeks-extensive approach and though we will be sure to keep people up-to-date as it progresses, this is all there is to give by way of an update.”

Ahead of agreeing to remedy for medical melancholy, Fetterman was in George Washington College Healthcare facility following he was emotion lightheaded.

Fetterman suffered a in close proximity to-deadly stroke just before the Pennsylvania Democratic principal in 2022.

Fetterman’s stroke became an situation during campaign, and compelled him to use auditory processing equipment to fully grasp inquiries and he experienced issue talking.

Fetterman also underwent operation to implant a pacemaker with a defibrillator to control two heart disorders, atrial fibrillation and cardiomyopathy, and expended considerably of the summer recovering and off the campaign path.

Fetterman went on to defeat GOP nominee Mehmet Oz to acquire the seat that was held by now-retired Republican Pat Toomey.

If you’re battling with psychological wellness, get in touch with the Countrywide Suicide Avoidance Hotline at 1-800-273-8255 or 988. CBS Information Philadelphia also has a checklist of psychological health and fitness assets.

CBS3 Staff members

The CBS3 Staff is a team of skilled journalists who provide you the content on CBSPhiladelphia.com.

February 26, 2023

Israel introduces bill to limit medical treatment for Palestinian prisoners

Israel’s parliament on Thursday handed the 1st phase of a monthly bill to halt funding non-important healthcare treatment method for Palestinians in Israeli prisons, in the most current collection of punitive steps taken towards detainees.

The authors of the invoice, which was supported by 42 Knesset associates, explained Israel’s existing jail coverage as “unreasonably lenient” in direction of stability prisoners.

It is unclear what the authors of the bill deem as non-necessary professional medical treatment.

“The health care expert services provided by the governing administration to prisoners need to not exceed primary professional medical treatment. There is no explanation or logic to finance cosmetic treatments at the cost of taxpayers,” they have been quoted as declaring by Israeli broadcaster Kan.

The move aims to “deny prisoners accused of subversive functions against the Point out of Israel of the ideal to acquire funding for healthcare treatment options intended at enhancing good quality of life and [medicine] not integrated in the basket of wellness solutions”.

The bill was launched by the Jewish Electricity, the get together of significantly-appropriate Countrywide Safety Minister Itamar Ben-Gvir, and the opposition Countrywide Unity Bash.

‘Slowly killing’ prisoners

Zaher Birawi, chairman of the civil society organisation Europal Discussion board, explained to Middle East Eye that the legislation is aimed at “bit by bit killing” Palestinian prisoners.

These types of policies have been applied from Palestinian prisoners for a long time, Birawi claimed, but now “they are using on legitimacy via the Knesset”.

The monthly bill also stipulates that in fantastic scenarios, the nationwide protection minister, in session with the defence ministry, may well authorise the funding of treatment plans for exclusive causes.

A Palestinian guy died in this medic’s arms. Then he realised it was his father

Examine Much more »

Birawi believes that, if handed, the monthly bill would be tantamount to the “legalisation of medical carelessness and as a implies of punishment or even execution”.

In recent months, Ben-Gvir has set his sights on Palestinian prisoners in Israeli jails.

Because becoming a member of Primary Minister Benjamin Netanyahu’s government late last year, the safety minister has vowed to crack down on the therapy of Palestinian prisoners, whom he promises are staying treated also nicely.

Before this thirty day period, Ben-Gvir ordered the closure of Palestinian prisoner-operate bakeries in Israeli prisons and that detainees would only be specified four minutes to shower.

The head of the Palestinian Prisoner’s Club, Qadura Fares, condemned the newest move as a breach of international legislation that warranty “the suitable to treatment and well being treatment for prisoners” by the occupying electricity.

In assertion, Fares included that Israel continues to “dismiss almost everything that has been permitted by the intercontinental procedure, without having any problem, and in mild of intercontinental silence, the occupation authorities will carry on to invent racist legislations and rules”.

‘Inflaming general public opinion’

In toughening the conditions of Palestinian prisoners, this sort of guidelines are aimed at responding “to a broad public notion that Palestinian prisoners enjoy comparatively very good cure in Israeli jails”, said Yonatan Touval, an analyst at the Israeli Institute for Regional Overseas Policies (Mitvim).

In response, Palestinian prisoners in jails throughout Israel have started a series of mass civil disobedience actions to protest versus punitive actions.

The actions will culminate in a starvation strike at the start off of the Muslim month of Ramadan in late March, prisoners declared final month.

Ben-Gvir’s go from Palestinian prisoners also allows him to “declare that he is offering on his election assure to guide a tougher stance on law and buy, primarily as he lacks any practical and meaningful coverage that would enhance safety on the floor”, Touval instructed MEE.

Within the initial 7 days of the new government’s development in December, Ben-Gvir declared plans to put into practice numerous punitive measures versus incarcerated Palestinians.

‘Any deterioration in the ailments of Palestinian prisoners could inflame public impression across the West Bank and the Gaza Strip’

– Yonatan Touval, analyst

Roughly 140 Palestinian prisoners have been transferred to Israel’s infamous Nafha jail, located in the southeast Negev desert, in recent months. The jail is notorious for its terrible residing ailments that some prisoners explain as “inhumane”.

Touval believes that even though Thursday’s bill however needs to go two far more phases ahead of becoming legislation, the cumulative affect of Ben-Gvir’s policies bears dangers.

“The state of Palestinian stability prisoners is an incredibly sensitive difficulty for Palestinians in the course of the occupied territories,” he stated.

Tensions in the West Bank are currently at a boiling stage, with at the very least 14 Palestinians killed by Israeli forces this 7 days on your own. So far this yr, 62 Palestinians and 10 Israelis have been killed.

“Any deterioration in the circumstances of Palestinian prisoners could inflame community belief throughout the West Bank and the Gaza Strip,” stated Touval.

“Specified the latest escalation in violence on the floor, the additional tension that the Israeli govt is now placing on Palestinian prisoners could demonstrate to be explosive.”

February 26, 2023

Around 400,000 women to receive cheaper menopause treatment under new scheme

Assistance IS Here: All-around 15 per cent of girls aged 45-64 in England are presently recommended HRT (Image by PA)

Menopause cure could be designed more affordable for hundreds of hundreds of gals as portion of a scheme to slash prescription expenditures.

The Department of Overall health introduced that commencing April 1, gals who have been prescribed hormone alternative remedy (HRT) to enable with menopause will have accessibility to a year’s value of treatment for just less than £20. Up to 400,000 gals in England will be capable to choose benefit of the new method and shell out a solitary sum for a complete 12 months of HRT, conserving them hundreds of lbs . annually.

The prescription pre-payment certificate for HRT will have a 12 months validity period of time and can be employed an unlimited variety of instances throughout that length. A range of HRT prescription merchandise, which includes patches, tablets, and topical preparations, will be manufactured offered to people today who use the application.

Read Much more: What is perimenopause, and what are the signs or symptoms and therapy?

Women of all ages can use for the certificate on the internet at the NHS Enterprise Services Authority or in human being at a pharmacy that is authorised to sell the certificates. The announcement follows the publication of the Government’s women’s health tactic for England very last summer.

Minister for Gals Maria Caulfield mentioned: “Around three-quarters of ladies will experience menopause indications, with one-quarter dealing with critical indications, which can significantly impression their quality of existence. Reducing the value of HRT is a huge minute for improving women’s well being in this country, and I am proud to be saying this momentous stage ahead.

“In our Women’s Wellbeing Strategy, we produced menopause a leading precedence – by creating HRT additional accessible. We are delivering on our determination to women of all ages.”

Individuals who use the plan can get a checklist of HRT prescription merchandise, such as patches, tablets and topical preparations (Picture by PA)

According to the Section of Wellbeing in England, 15 for every cent of ladies between the ages of 45 and 64 are currently acquiring HRT prescriptions. “Creating HRT a lot more inexpensive will have a vastly advantageous impression on the life of so numerous ladies,” stated Dame Lesley Regan, the government’s ambassador for women’s overall health, adding “This pre-payment certificate is a big action ahead in prioritising the wellness and wellbeing of females.”

Dr Ranee Thakar, president of the Royal School of Obstetricians and Gynaecologists, claimed: “We know that price tag can be one particular of the limitations that gals face in accessing therapy to control their indications in the course of menopause, and the introduction of HRT pre-payment certificates is a constructive action to improve entry to HRT.

“This announcement is an vital 1st move, and we hope that much more will be completed to deal with the troubles and inequalities faced in accessing menopause treatment and treatment method.”

By Dominic McGrath, PA

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February 25, 2023

Addiction Treatment May Be Coming to a Pharmacy Near You

Despite an overdose epidemic that killed 107,000 people last year, nearly 9 in 10 Americans who need medication to treat their addiction to deadly opioids aren’t receiving it.

Surprising new results from a first-of-its-kind study in Rhode Island could hold a key to getting addiction medication to more people who need it: allowing patients to get prescriptions at their local pharmacy rather than a doctor’s office. The change would particularly help those with low incomes who lack housing and transportation, the study found.

The Biden administration and states have been working to reduce barriers to addiction treatment. And state officials say they plan to use a chunk of the $26 billion they will receive from pharmaceutical companies in opioid settlement funds to increase access to addiction medication.

But in the more than two decades since the lifesaving addiction medication buprenorphine has been available, most of the nation’s more than 900,000 doctors have been unwilling to prescribe the medication. Experts cite stigma and a lack of understanding of addiction medicine as the reasons for the reluctance.

Those doctors who do prescribe buprenorphine often have long waits for appointments, and many take only a few patients.

The new research conducted by Brown University showed that patients who received buprenorphine for their opioid addiction from pharmacists at specialized drug stores in the Providence area stayed in treatment longer than those who saw doctors in a clinic or private practice.

Co-author Dr. Josiah Rich, professor of medicine and epidemiology at Brown, said he and his colleagues set out to show that pharmacists were willing and able to counsel addiction patients and provide the medication.

“We were surprised to find that patients actually preferred to receive their treatment from pharmacists,” he told Stateline.

In the study, 100 patients started taking buprenorphine after visiting specially trained pharmacists at six retail pharmacies in the Providence area. From that group, 58 patients volunteered to be randomly assigned either to a clinic or doctor’s office for continued care or to keep visiting the pharmacy for check-ins and refills.

One month later, 89{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of patients assigned to a pharmacy continued to show up for their medication and consultation, compared with only 17{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of those who received buprenorphine the usual way — in a clinic or doctor’s office.

“What we have in this epidemic is a workforce issue,” Rich said. “We don’t have enough bodies prescribing buprenorphine. Physicians have had more than 20 years to go ahead and prescribe it for their patients with opioid use disorder and the vast majority have said, ‘No thank you.’”

According to a 2020 report from the U.S. Department of Health and Human Services, 40{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of counties do not have a single health practitioner who can prescribe buprenorphine.

From 2000 to 2016, only physicians could prescribe buprenorphine, and only after they completed eight hours of training and received permission from the Drug Enforcement Administration. When the federal government authorized the nation’s roughly 235,000 nurse practitioners and 133,000 physician assistants to prescribe buprenorphine beginning in 2016, the number of people receiving the medication rose substantially, Rich said.

Allowing pharmacists, who number more than 315,000, to prescribe and administer the drug could “take a huge bite out of the epidemic,” he said.

Almost 9 in 10 Americans live within five miles of a retail pharmacy, according to a study in the Journal of the American Pharmacists Association.

“Pharmacists are the most highly trained and underappreciated health professionals we have, and they are in the trenches,” Rich said. “They see what’s going on out there. We need them now and apparently, they’re up for the task.”

State Support

In Rhode Island, the pharmacist program was conducted in collaboration with an assigned doctor whom the pharmacist consulted by phone after initially talking to and assessing a patient. The prescription was signed by the supervising physician and subsequently renewed by the pharmacist.

If states try to ramp up similar programs, experts say, the sticking point will be how to cover the pharmacists’ time consulting with patients. Under Medicaid, the federal-state program for low-income patients, pharmacists are not technically considered health care providers and are, therefore, not eligible for reimbursement for their services.

For pharmacist-based addiction treatment programs to take off, states would likely need to amend their Medicaid programs to include pharmacists as providers.

In addition, 11 states — Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Wisconsin and Wyoming — have yet to approve the expansion of their low-income health programs under Obamacare to cover adults with low incomes.

Short of expanding Medicaid and allowing pharmacists to bill for their time, states could use opioid settlement dollars to fund a pharmacy-based addiction treatment program, Rich and others suggested.

Removing Obstacles

Other recent efforts at the federal and state levels also have targeted the opioid epidemic.

In a move aimed at reducing overdose deaths, an expert panel of advisers to the Food and Drug Administration voted earlier this month to recommend that the overdose antidote naloxone be sold over the counter in pharmacies without a prescription.

If approved by the federal agency, it would allow pharmacies to offer the immediate life-saving drug to anyone who is using drugs or knows someone who is.

In another action aimed at stanching overdose deaths, President Joe Biden signed a bill eliminating the requirement that medical providers obtain special permission from the Drug Enforcement Administration to prescribe buprenorphine. Use of buprenorphine and other addiction medications has been shown to reduce the likelihood of experiencing an overdose by at least 50{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc}.

Advocates for addiction patients say that doing away with the requirement could reduce much of the stigma within the health care community connected to prescribing buprenorphine.

Rhode Island Experiment

Allowing patients to walk into a pharmacy and ask to get started on buprenorphine, or start retaking it after they have relapsed or misplaced their medication, could further reduce the stigma of addiction treatment, advocates say.

Andrew Terranova, pharmacy manager at Genoa Healthcare in Providence, Rhode Island, participated in the Brown University pilot. He said he’s still serving many of the patients he treated during the trial, which was conducted from February through April 2022.

Terranova said his patients told him they preferred receiving treatment at the pharmacy instead of at a clinic or doctor’s office because they could walk in any time of day and immediately see the pharmacist and pick up their prescriptions.

It’s also more convenient, he said. When patients go to a doctor’s office or clinic, they typically have to make a second trip to a pharmacy to pick up their medication.

“My experience with patients,” Terranova said, “showed me that many people seeking treatment face homelessness, stigma, judgment and economic barriers every day. So, coming into a pharmacy and being greeted by a pharmacist who wants to sit down with you and talk about being healthy was very much appreciated.”

In the Brown University study, a third of patients identified as Black, Indigenous or persons of color. Nearly half lacked a permanent residence.

According to the Substance Abuse and Mental Health Services Administration, drug use is highest among American Indians and Alaska Native, multiracial and Black people.

Pharmacies also offer flexibility that’s not always available at a doctor’s office. Terranova recalled a young woman who lived in a shelter and came to the pharmacy with her kids every day before work to pick up her medication because she didn’t have a safe place to store it in the shelter. She knew she couldn’t have done that at a doctor’s office, he said.

Overall, Terranova said he and the other pharmacists at his pharmacy found the Brown University program rewarding. “The improvement we saw and our interactions with patients, and to feel their gratefulness for getting help in a way and manner they weren’t used to, was extremely rewarding,” he said.

“I’d be more than willing to jump in and keep helping addiction patients if the program were to ramp up,” he said. “We’d all be willing to participate again and continue what we started.”