Toward Ending the Opioid Crisis

 Big numbers obscure individual suffering. An estimated three million Americans live with opioid use disorder (OUD), and over 80,000 Americans died from opioid overdoses in 2021. Each of those deaths represents an individual tragedy that ripples through families, friends, and communities. Our challenge is to see and be driven by the personal tragedies that make up those big numbers. We can tackle this problem by focusing on solutions that help individual patients struggling with this debilitating disease.

To end the opioid crisis – today, largely a fentanyl crisis – we must treat patients where they are in their lives, and that is often in and near the criminal justice system. Americans suffering from OUD in correctional settings are far more likely to overdose upon release. They also face barriers to lifesaving treatments while incarcerated. Because 60 to 65 percent of persons with substance use disorders (SUD), including OUD, encounter the criminal justice system at some point in their journey, intervention that supports recovery and prevents re-incarceration should begin there. Many patients speak to the ‘moment’ they were ready to seriously enter treatment towards recovery. The numbers demonstrate that, for some, the multiple touchpoints of the criminal justice setting serve as that key ‘moment.’ 

Underserved populations, including those within the criminal justice system, are more likely to be impacted by OUD. In fact, a majority of people with OUD will experience at least one instance of incarceration, most likely in a local jail. Further, former inmates released to the community are between 10 and 40 times more likely to die of an opioid overdose than the general population, especially within the first few weeks after returning to society.

Despite these staggering statistics, only 5% of people with opioid use disorder in the criminal justice setting receive medication for opioid use disorder (MOUD). Persons left untreated often re-offend and return to incarceration, costing the individual and the community alike. Perhaps this cycle flows from OUD being stigmatized as a moral and criminal issue and not treated as a disease of the brain.

To turn the tide on the opioid epidemic, it is crucial to improve access to medication for people who are disproportionately impacted by this epidemic. We must act to make treatment more available to this population so they can have a chance at recovery and successful reentry into society. 

Breaking the stigma is an important step towards helping those with OUD. National surveys suggest that there are still negative attitudes around those suffering from OUD, even as the disease impacts much of the population. As awareness and understanding grows, we can hope to change attitudes, broaden the conversation around this epidemic, and encourage the need for treatment inside the criminal justice system.

Improving access to medication for people in the criminal justice system with OUD should also lower recidivism rates and reduce overdose deaths. Studies have shown that incarcerated individuals who receive MOUD have one-third lower rearrest and reincarceration rates  compared to those who receive no treatment.

At the federal level, Congress is considering legislation – the Medicaid Reentry Act – to expand access to addiction treatments and other services in the 30 days before someone is released from prison or jail. This bill seeks to address the coverage gap from current policy, which blocks patients who are incarcerated from federal health programs. Easing those restrictions would go a long way to helping people transition back to their communities and their families and reduce the risk of relapse and overdose.

It’s easy to look at big numbers and not see individual people. Unfortunately, that is often what happens to people in our prisons and jails who suffer from OUD. When we look beyond the numbers, we see the thousands of individual tragedies impacting our family, friends, and neighbors. We also see that the answers are well within our reach, the first of which is providing treatment for people in the criminal justice system.

Mark Crossley is the Chief Executive Officer at Indivior.

https://www.realclearhealth.com/articles/2022/09/02/how_to_end_the_opioid_crisis_111400.html

PhRMA and BIO seek changes in FDA’s guidance to mitigate drug shortages

 Last month, several pharma advocacy groups voiced both their approval and concerns with the FDA’s draft guidance concerning how to handle potential drug shortages. The draft was intended to help companies form and commit to risk management plans (RMPs) to assist with any shortages of drugs or biologics products.

While groups such as Civica and The Biosimilars Forum offered comments to the FDA to change the guidance, other groups are letting the FDA know its concerns.

The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted comments to the FDA initially appreciating the FDA’s efforts in establishing a framework but feeling that the guidance needs to be changed.

PhRMA recommends that the FDA update the guidance to reflect recent changes around terminology and that the FDA use a risk-based approach to revise the RMPs instead of an annual basis that is laid out in the draft.

The lobbying group also recommends that the FDA update its guidance to acknowledge that existing “Pharmaceutical Quality System” processes that are used to maintain a state of control and drive continuous improvement could be used to support the RMP and RMP review process, where appropriate.

PhRMA notes that RMPs for similarly situated products may cross-reference or use overlapping concepts. The organization uses the example of products that source the same raw materials from the same facility, which can use the same risk mitigation approaches. It also encouraged the FDA to expand upon how the regulator will use information included in RMPs to inform its surveillance, including its approach to inspections.

The advocacy group also encourages the FDA to address how it will use RMPs in other related initiatives and to revise the guidance to acknowledge that the scope of the RMP’s authority is limited to a particular stakeholder.

“PhRMA appreciates the work FDA has done in helping to prevent and mitigate drug shortages, including in working collaboratively with industry. The draft guidance largely complements ongoing industry efforts to mitigate risk by having continuity plans in place to address supply chain or other disruptions,” PhRMA writes.

The Biotechnology Innovation Organization, or BIO, has also taken umbrage at some of the language and the timing of the draft guidance.

BIO’s initial comment states that the guidance using terms such as “primary stakeholder,” “secondary stakeholder” and “other stakeholder” to describe manufacturers is a broad definition. BIO noted that it could be interpreted that manufacturers of any step in the active API or drug manufacturing process need to have RMPs and is asking for clarification.

“Such a requirement would be highly burdensome to manufacturers of API intermediates or drug product intermediates and could be non-value added since manufacturers of intermediates might not have knowledge of the information needed to provide a meaningful RMP,” the comment says.

The BIO comment also notes that neither the draft guideline nor the Federal Register notice provides a timeline for implementing the final guidance and that manufacturers have had little direction on how to prepare. BIO is requesting that a period of at least two years from the publication of a final guideline before the FDA reviews RMPs should be implemented.

With the guidance using the term API, which usually applies to small molecule drugs, BIO commented that the FDA should clarify the scope of the guideline to include biologics and vaccines as well as replace API with “drug substance.” The organization also wants the FDA to specify what products specifically must have RMPs.

BIO’s comment also states that having two-way communication between contract manufacturing organizations can be more beneficial.

https://endpts.com/phrma-and-bio-seek-changes-in-fdas-guidance-to-mitigate-drug-shortages/

Russia Reports 50,000 COVID-19 Cases for Second Day Running

 Russia recorded more than 50,000 new daily COVID-19 cases for the second day running on Saturday, the government's coronavirus task force said.

Over the last 24 hours, 51,699 cases were detected across Russia - the most in a single day since March 9.

On Friday, Russia's caseload passed the 50,000 mark for the first time in almost six months.

Infections rose in July and August as new highly-transmissible variants of the coronavirus swept across the country.

The task force said 92 people had died with COVID-19 over the last 24 hours.

According to excess fatality statistics, Russia has been among the most severely affected countries by the pandemic, with vaccine uptake slow and the government reluctant to impose restrictions beyond a short lockdown in 2020.

https://www.usnews.com/news/world/articles/2022-09-03/russia-reports-50-000-covid-19-cases-for-second-day-running

Optum Acquires Houston-Based Physician Group for $2 B

 UnitedHealth Group's healthcare services division, Optum, will reportedly acquire Kelsey-Seybold for approximately $2 billion, according to the Star Tribune.

The acquisition of Kelsey-Seybold, a physician group based in Houston that includes cancer and women's health centers, two ambulatory surgery centers, and a sleep center, was first announced in April, but few details have emerged since, the Star Tribune reported.

However, Optum, based in Eden Prairie, Minnesota, did provide a statement to MedPage Today about incorporating Kelsey-Seybold's operations and staff into the Optum network.

"Optum is aligned with Kelsey-Seybold's care delivery model that brings coordinated, value-based care to patients and employers," the company said. "We have a shared vision of supporting high-quality care with better experiences for patients and providers at a lower total cost of care."

Optum also highlighted its plans to focus on expanding services around the communities that Kelsey-Seybold has been serving.

"We look forward to working together to advance Kelsey-Seybold's compassionate, coordinated care model to more patients and communities in the Greater Houston area," the statement concluded.

As part of this effort, Kelsey-Seybold has already begun construction on expanding one of its healthcare campuses, which includes an ambulatory surgery center and a cancer center, according to a recent press release. The expanded site will reportedly triple the number of possible providers at that location to 82, while also adding "four operating rooms, three endoscopy suites, and a procedure room to support interventional pain management and interventional radiology services."

In addition to that project, Kelsey-Seybold has announced several others that will either expand existing healthcare facilities or break ground on new locations, the press release noted.

These expansion projects will add to Optum's fast-growing network of physicians around the country.

In March 2021, Bloomberg reported that Optum's network of 53,000 physicians made up 5.4% of all U.S. physicians. At that time, it was considered to be the largest employer of physicians in the country. Since that report, the company has reportedly added 10,000 more physicians.

Optum's website states that it currently employs 60,000 physicians in more than 2,000 locations across the country.

It is not clear whether those numbers reflect the deal with Kelsey-Seybold, which claims to have more than 600 healthcare professionals and 30 clinics on its website.

According to the Bloomberg report, acquisitions by Optum, such as the deal with Kelsey-Seybold, are "a key driver of UnitedHealth's growth" to expand healthcare services and increase revenue and profits. "More than any of its peers, the company has sought to purchase medical groups and other providers," the article noted.

UnitedHealth Group also announced that it acquired KS Plan Administrators, which is affiliated with Kelsey-Seybold and covers about 41,000 Medicare beneficiaries, according to Becker's Healthcare.

The healthcare giant reported more than $80 billion in revenue in the second quarter of 2022.

https://www.medpagetoday.com/special-reports/exclusives/100531

MedPAC Commissioners Mull Proposals to Change Part B Drug Payment

 Members of the Medicare Payment Advisory Commission (MedPAC) spoke up Friday in favor of considering new approaches to the way Medicare pays for Part B drugs.

"I think we're going in the right direction," said commissioner Gary Poulsen, MBA, of Intermountain Healthcare in Salt Lake City, Utah. "I think this is an improvement."

Having grown from previous commission discussions on the topic, Poulsen was referring to proposals presented at the commission's September meeting by MedPAC principal policy analyst Nancy Ray, MS. Ray noted that price has been the largest driver of Part B spending growth, with Medicare spending $40.7 billion on Part B drugs in 2020. And that spending is highly concentrated, with 52% coming from just 20 drugs.

Currently, Medicare pays for Part B-covered drugs -- those dispensed in physician offices or other outpatient facilities -- based on the average sales price (ASP) of the drug plus a 6% administration fee. The MedPAC staff proposed an alternative in which Medicare would pay the ASP plus the lesser of three options for the administration fee: 6%, 3% plus $21, or $175 per drug per day. This approach, Ray said, converts a portion of the "percentage" part of the administration fee to a fixed fee ($21) in one instance and caps the administrative add-on fee for lower-priced drugs at 6% and for higher-priced drugs at $175. She noted that the numbers were illustrative and that other numbers could be considered.

Using this formula would reduce the differences between drugs in administrative add-on fees, and would result in the biggest fee reduction for the higher-priced drugs. For example, a drug with an ASP of $15,000 would have an add-on fee of $900 under the current formula, but under the proposed alternative, that figure would be $175, Ray said.

Ray also outlined options for using reference pricing in cases where higher-priced drugs have a lower-priced therapeutic alternative. Currently, the economic incentive is to select a higher-priced drug that will result in a larger reimbursement because the administrative fee is based on a percentage of the drug's price. Ray presented three alternative options for payment, based on:

• Lowest ASP of the products in the reference group
• Volume-weighted ASP of all products in the reference group
• Lower of the volume-weighted ASP and the ASP of the drug being administered

These options would generate savings for beneficiaries and taxpayers, she said.

Commissioner Robert Cherry, MD, of UCLA Health in Los Angeles, expressed concerns about one idea Ray mentioned in the reference pricing proposal: that Medicare could consider whether Medigap policies could cover the costs for drugs whose prices were higher than the reference price.

"My concern with that is just from an equity perspective, whether that's actually a viable solution or not," he said. "Because in order to purchase those Medigap private supplemental policies, you have to be able to afford those, and so it sort of excludes another population of beneficiaries that could not necessarily benefit from appropriate drugs and therefore their provider may not be able to order it."

Commissioner Stacie Dusetzina, PhD, of the Vanderbilt University School of Medicine in Nashville, seconded that point:"I really dislike the idea of requiring coinsurance for beneficiaries in that case; I think we should remove the reference to beneficiaries paying a little bit more."

Dusetzina said she "fully endorsed" the reference pricing model for biosimilars and biologic drugs. "I think that's exactly where we should go," she said. However, "the other therapeutic alternatives piece is more complicated and figuring out how we define what gets to be counted as a substitute. I think it makes that part a little bit trickier, but I'm in support of that plan."

During her presentation, Ray also addressed the question of what to do about drugs such as aducanumab (Aduhelm) that have been approved by FDA but are thought to have an uncertain clinical benefit. One idea in this area would be to cap payments for such drugs until a confirmatory trial shows a clinical benefit.

Commissioner Scott Sarran, MD, of MoreCare in Cook County, Illinois, reflected on the way Medicare is covering Aduhelm as part of its coverage with evidence development (CED) program; Medicare only pays for the drug for patients who are enrolled in an Aduhelm clinical trial, although there is no set deadline for completing the trial.

"I wonder whether the best approach is to encourage CMS to apply CED more often than they previously have and recommend they do it with real defined time frame, beyond which [the agency] would refuse to cover it under any circumstances," he said.

Commissioner Lawrence Casalino, MD, PhD, of Weill Cornell Medical School in New York City, said he was "very enthusiastic" about both the reference pricing recommendations and also about changing the current ASP-plus-6% reimbursement formula. He downplayed concerns that these payment changes would make drug companies less interested in developing new treatments.

"Pharmaceutical companies are extremely profitable and have incentives to innovate," he said. "I'm not sure pharmaceutical companies wouldn't continue to innovate if they were a little less profitable."

But commissioner Marge Ginsburg, BSN, MPH, of the Center for Healthcare Decisions in Sacramento, California, disagreed, urging caution about those proposals.

"What happens, as we all know -- Big Pharma rises up, and the public rises up because the public gets infuriated to think we're going to stop innovation by these Draconian measures to cut costs," she said. "I do think we need to be careful...I'm very excited about the approaches we're talking about, I just want to make sure that we are very aware of the power that Big Pharma has over the general public."

https://www.medpagetoday.com/publichealthpolicy/medicare/100538

Newsom Veto Deals Blow to Safe Injection Sites

 Last week, California Gov. Gavin Newsom (D) vetoed a bill that would have permitted the state to launch a pilot program to open supervised injection facilities in California's largest cities.

Sometimes called SIFs, safe consumption sites, or overdose prevention centers, these are spaces where people can legally consume or inject pre-obtained illicit drugs under supervision to prevent overdoses.

In his veto letter, Newsom said he had long been a proponent of harm-reduction strategies, but argued that he was concerned about launching such sites without "engaged local leadership" and plans to sustain the sites.

He warned that the "unlimited number" of sites the bill would have authorized, "could induce a world of unintended consequences" in San Francisco, Los Angeles, and Oakland, and exacerbate "drug consumption challenges."

Melissa Moore, JD, director of Civil Systems Reform at the Drug Policy Alliance, said the bill authorized "four specific jurisdictions" -- San Francisco, Los Angeles, Los Angeles County, and Oakland -- to open overdose prevention centers, and would not have incited the kind of explosion of sites the governor described.

"Unfortunately, what we're doing now is the kind of worst case scenario that Governor Newsom and others are trying to use as a fear tactic ... We're already living that reality, where public bathrooms are being closed down, because there's a concern that people are going to use in there and overdose and die," Moore said.

Allowing people who are in the most vulnerable period of their lives to receive services, "I don't really see what the downside could be," she added.

One benefit of state authorization would have been the legal protection afforded to doctors, nurses, social workers, and others licensed by the state, explained Alex Kral, PhD, an epidemiologist with the nonprofit health research institute RTI International.

Without that cover, licensing boards might say, "Look, we don't approve of this," he said.

While clinicians can work in these facilities, they may be putting their careers at risk, Kral noted.

In addition, without authorization to free up city, county, and state public health funding, it will continue to be difficult for programs to open and to cover the costs of the work they're doing, Moore said.

Newsom said he would task the Secretary of Health and Human Services and city county officials with determining "minimum standards and best practices" for developing programs that would be safe and sustainable that could be recommended to the state legislature.

California State Senate Republican leader Scott Wilk applauded the governor's veto. "People struggling with addiction need help, not a legal place to shoot up," he said.

(MedPage Today previously covered some issues about the debate about the merits of the harm-reduction model.)

Moore said she was heartened by comments from San Francisco City Attorney David Chiu reiterating his support for the program and hinting that the governor's veto would not stop the city from launching a center.

New York

The first two publicly recognized overdose prevention programs, operated by OnPoint NYC, opened in New York City on Nov. 30, 2021.

One site, in East Harlem, is run by medical staff and has a health clinic on site. The other, located in Washington Heights, has adopted a "peer" model, which means the responsible staff have lived experience with substance use disorders.

An analysis of the first 2 months of the program's efforts, published in JAMA Network Open in July 2022, found that staff responded 125 times to help "mitigate overdose risk"and gave naloxone 19 times and oxygen 35 times, and monitored respiration and blood oxygen levels 26 times. Staff also intervened 45 times to respond to "stimulant-involved symptoms of overdose."

In all, emergency medical services were called to the sites five times and clients were taken to the emergency department three times. No fatal overdoses occurred at either site or during hospital visits, and more than half of those who used the sites made use of other supports.

"The fact that OnPoint not only offers the overdose prevention center but also has showers on site... has a laundry facility, has a drop-in center and a lot of wraparound services in terms of mental health support, general health and wellness, acupuncture for people dealing with withdrawal ... all of those things under one roof, I think really shows the potential for overdose prevention centers," Moore said.

New York Mayor Eric Adams has voiced support for the sites, and in late May tweeted about shifting to a 24-hour model.

"For that to happen, it will be really important to get the state authorization in New York," Moore said, which is something advocates have been pressing New York Gov. Kathy Hochul (D) to do for some time.

Right now, private philanthropy dollars are being used to support the overdose prevention portion of the site's programs, Moore said.

Philadelphia

Safehouse, a Philadelphia nonprofit, has plans to open its own safe injection site, but is waiting for the federal government to give the green light after the Department of Justice, under President Trump, sued Safehouse in 2019.

Provisions of the Controlled Substances Act, dubbed the "crack house statute," make it illegal to run, own, or rent a site with the intention of using, selling, storing, or manufacturing drugs.

The Biden administration appears less "antagonistic" toward such sites, compared with the Trump administration, Moore noted. Under President Biden, the White House funded harm reduction programs for the first time in its budget, and while the amount was less than what is needed, Moore was encouraged.

Safehouse Vice President Ronda Goldfein, Esq., said the group continues to have "productive conversations" with the Department of Justice (DOJ) about opening their site.

While New York City didn't wait for DOJ approval, Safehouse has always felt strongly that it was better to open "in the light," Goldfein said. Not only will that reduce stigma, it also makes it easier to secure institutional partners and funding, to ensure the program's sustainability, she said.

And as she told MedPage Today previously, the group is also not inclined to ignore a court order.

"Ideally, we reach an agreement, which allows appropriate boundaries," or "guard rails" as the DOJ call them, that both parties can agree to.

The current deadline for the DOJ to respond to Safehouse's claims is September 22. (The response date has been repeatedly postponed since late 2021).

While Goldfein said she isn't hopeful that the matter will be concluded by September, she anticipates an answer "by the fall."

She's optimistic that a settlement for Philadelphia will encourage other jurisdictions. "If DOJ says, 'If you do x, y, and z, we won't prosecute you in Philadelphia,' it's hard to imagine that they would prosecute you in New York or California," she said.

Rhode Island, Other Cities

In July 2021, Rhode Island Gov. Daniel McKee (D) signed a law authorizing a 2-year pilot of safe injecting sites, becoming the first state in the nation to do so.

The state began accepting applications in March, but to date, Annemarie Beardsworth, a spokesperson for Rhode Island's Department of Health, said it has not received any applications.

"This will be a month's long process, given all the approvals required at the municipal and [s]tate level, as spelled out in Rhode Island's regulations. The current pilot program ends in 2024," she noted in an email.

Momentum around expanding overdose prevention sites is continuing to build in cities such as Chicago and Baltimore, Moore said.

In July, the BRIDGES Coalition group of local advocates set up a "mock overdose prevention space" at the NomüNomü Arts Collaborative in Mount Vernon, Rhode Island, according to The Baltimore Sun.

Maryland Governor Larry Hogan called the sites "absolutely insane."

https://www.medpagetoday.com/psychiatry/opioids/100539

IRS 'unintentionally posted some private taxpayer information to its website'

 The Internal Revenue Service (IRS) unintentionally posted some private individuals’ tax information on its website last week before taking it down, officials said in a letter to Congress on Friday that was obtained by The Wall Street Journal. 

Anna Canfield Roth, the acting assistant secretary for management in the Treasury Department, said in the letter to Rep. Bennie Thompson (D-Miss.), the chairman of the House Committee on Homeland Security, that the IRS determined that some machine-readable Form 990-T data was made available for bulk download last Friday, Aug. 26. 

The Journal, which first reported the news, stated that the letter also went to other key members of Congress. 

The IRS did not immediately return a request from The Hill for comment. 

Tax-exempt businesses use the Form 990-T to report and pay income tax on income from certain investments or income that is unrelated to their exempt purpose. 

The letter states that the IRS took immediate action to address the issue once it was noticed. 

The agency said it has removed the files from the website and will replace them with updated files in the coming weeks. It will also work with groups that routinely use the files to remove the erroneous files and replace them with correct versions as they become available. 

The IRS plans to contact all filers who were impacted in the coming weeks

The agency determined that “limited” information for about 120,000 people was posted, but the data did not include Social Security numbers, individual income information, detailed financial account data or other “sensitive” information that could impact their credit.

The data did include some individual names or business contact information in some cases. 

The letter states that the agency is continuing to review the situation, and the Treasury Department directed the IRS to conduct a “prompt review” of its practices to ensure necessary guards are in place to prevent future unauthorized disclosures. 

Officials will provide additional information, including summaries of the detection, response and remediation activities within 30 days, according to the letter.

https://thehill.com/policy/finance/3626552-irs-unintentionally-posted-some-private-taxpayer-information-to-its-website/