The Meals and Drug Administration desires to shift to a simplified COVID-19 booster strategy, but responses to the plan are proving that the challenge is a complex 1.
In documents posted this 7 days, the Fda proposed a booster shot technique very similar to the flu vaccine program, with an up-to-date shot matched to circulating strains provided annually in the slide for most Us citizens. Its committee of outside the house vaccine industry experts is established to focus on the subject all through a assembly on Thursday.
But some gurus are inquiring regardless of whether readily available information supports these types of a system.
“The large issue is: How normally do we require repeat vaccination? And I you should not imagine we have a definitive remedy,” Joachim Hombach of the Entire world Well being Group claimed during a push briefing on Tuesday.
Hombach claimed that it is conceivable that the booster time body could be annual but raised worry that COVID-19 has has yet to turn into seasonal, with surges taking place in the summer season, drop and winter season.
“We also have to say that for the time getting COVID hasn’t really arrive down to the common seasonality that we see for other respiratory viruses,” Hombach said. “The virus is nonetheless incredibly unstable. So this is a little bit of an anticipation that we conclusion up in a seasonal pattern as we have, for instance, for influenza.”
Cartoons on the Coronavirus
WHO’s Maria Van Kerkhove agreed that the coronavirus and its quite a few variants nonetheless existing uncertainties.
“We don’t know the periodicity of this nonetheless. We have not witnessed SARS-CoV-2 settle into a sample in conditions of its virus evolution,” Van Kerkhove claimed, referring to the virus by its scientific name. “We have not yet observed a seasonal sample particularly in the temperate areas of the world. And we may perhaps get to that, but we’re not rather there still.”
Carlos del Rio of the Emory University School of Medicine mentioned he understands the wish to have a coverage in spot but included that the virus carries on to throw curveballs and complicate ideas.
“I believe that we’d like to see some thing basic and comparable to the flu,” del Rio, who is the president of the Infectious Conditions Society of The united states, reported in the course of a briefing on Tuesday. “But I consider we also will need to have the science tutorial this facts, and I consider the science suitable now is not essentially there.”
He added that far more investigate is needed to develop future generation vaccines that do a greater task of protecting against an infection.
“My plea is that we proceed undertaking exploration, we comply with the science and we make decisions dependent on science and not what is most effortless to most,” del Rio reported.
The large bulk of People in america are at the moment regarded undervaccinated by Facilities for Illness Manage and Prevention requirements. Just 15{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of Us residents have gotten the up-to-date COVID-19 booster shot, increasing inquiries about vaccine exhaustion with any strategy going forward.
Nonetheless, the transfer by the Food and drug administration is not a surprise, offered that users of the Biden administration and President Joe Biden himself have pushed for the concept of switching to an yearly COVID-19 shot.
“For most Individuals, a person COVID shot each year will be all they require,” Biden claimed at the White Residence in October when he acquired his up-to-date COVID-19 booster shot. “And if you get it, you are going to be protected. And if you really do not, you’re putting your self and other people today at unneeded chance.”
But even then his proposal raised eyebrows.
“Unfortunately, there are no info to assistance this assertion,” Eric Topol, professor of molecular medication at Scripps Study tweeted at the time. “Likely attainable by 2nd technology vaccines, but that needs precedence and means to be focused, which isn’t happening.”
H2o with nano-particles of Cannabidiol or CBD, derived from the Hashish plant, are shown on the shelf of a keep in Walnut Creek, California, April 26, 2019. (Picture by Smith Selection/Gado/Getty Visuals)
The Food stuff and Drug Administration (Food and drug administration) is reportedly arranging to announce a regulatory framework for merchandise like CBD that are derived from authorized hashish in the coming months amid considerations about merchandise high-quality and security.
CBD merchandise have proliferated in the several years considering that the enactment of the 2018 farm invoice legalized industrial hemp – a variant of the cannabis plant that lacks the intoxicating qualities of versions grown for usage as clinical or leisure marijuana. That opened the door for profits of CBD goods ranging from drinks and edible gummies to lotions and lotions that comprise no additional than .3{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} THC, which is the cannabinoid chemical that can induce a large in users and is illegal at the federal degree inspite of legalization in 21 states.
When asked for comment about the future regulatory plan, a spokesperson for the Food and drug administration offered Fox Business with a assertion by Food and drug administration Principal Deputy Commissioner Janet Woodcock, M.D., who is in cost of the agency’s initiatives to control hashish, that was also provided to the Wall Street Journal: “Supplied what we know about the basic safety of CBD so significantly, it raises issues for Fda about irrespective of whether these present regulatory pathways for food items and nutritional health supplements are correct for this substance. Food and drug administration is at the moment examining 3 Citizen petitions associated to this, and we strategy to react to them shortly.”
CBD products are generally touted as helping relieve agony, decrease stress and anxiety and endorse rest but can’t at this time be branded as dietary nutritional supplements or additional to meals products beneath Food and drug administration policies, and the agency has issued warning letters to many corporations about statements they’ve produced pertaining to their CBD products.
The Fda is investigating the results of CBD in conjunction with the Nationwide Institutes of Wellness (NIH), and individuals conclusions will inform its recommendations about laws for people products and solutions. A analyze by NIH observed that a pharmaceutical-quality CBD merchandise identified as Epidiolex has served decrease seizures in clients with epilepsy around the age of 2, but it also prompted diarrhea, exhaustion and elevated liver enzymes in some little ones.
At the time the Fda is ready to transfer ahead with building regulatory suggestions, it will have to come to a decision irrespective of whether CBD merchandise can be regulated as foods or dietary health supplements, instead than medicine, or if the agency will need to develop a new framework or phone upon Congress to enact a regulation on the topic.
Mainly because cannabis crops include dozens of cannabinoid chemical substances, like THC and CBD, among others, new hashish items that emphasize recently found out cannabinoids current a challenge for regulators.
Quite a few college students handled for achievable ‘cannabis overdose’ at California center school
Ten pupils were being treated for a attainable overdose at a center university in the San Fernando Valley, in accordance to investigators. FOX 11 LA’s Gigi Graciette spoke are living from the scene with LiveNOW from FOX’s Josh Breslow.
For instance, the most prevalent type of THC is identified as Delta-9, which has intoxicating houses and is unlawful at the federal amount. But Delta-8 THC can be derived from industrial hemp and falls into a authorized grey place in which it can be legally produced and marketed in spite of owning intoxicating qualities like its sister cannabinoid.
Norman Birenbaum, an Food and drug administration senior adviser who formerly worked on cannabis regulation in New York and Rhode Island, told the Wall Road Journal that the agency has “developing and much more intensifying quick-expression fears” about these Delta-8 solutions right after a baby in Virginia died following having Delta-8 gummies while a quantity of other teens and kids ended up sickened in Texas and Iowa.
The lack of a federal regulatory framework has provided rise to fears about purchaser safety and shortcomings in top quality assurance that may guide to THC being incorporated in some CBD goods meant to exclude it. It has also stored a range of organizations that ultimately prepare to enter this emerging marketplace on the sidelines thanks to authorized fears. Despite that hesitance, an Fda report from 2021 found that the CBD market place by itself was believed to be $4.6 billion final yr and forecasted it to quadruple by 2026.
As the FDA’s regulatory process plays out, the U.S. Section of Agriculture’s laws on hemp production illustrate the difficulties of great-tuning procedures around the manufacturing and processing of cannabis solutions.
A Congressional Investigate Company report identified that in 2021, hemp output was valued at $824 million throughout about 13,000 grower licenses all-around the place, and a dozen states had far more than 1,000 harvested acres of hemp in 2021 – led by Montana with 4,500 acres and Colorado with 3,100 acres. But the CRS report noted that about 20{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} of hemp developed in a offered year will exceed the legal restrict of no far more than .3{fe463f59fb70c5c01486843be1d66c13e664ed3ae921464fa884afebcc0ffe6c} THC, which goes to exhibit the “inherent pitfalls to farmers of expanding hemp inside USDA’s regulatory framework.”
6-1-2022 Food and drug administration Drug Security Communication
Due to safety considerations, the U.S. Food and Drug Administration (Fda) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was authorized to handle two unique types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Up-to-date conclusions from the UNITY-CLL medical trial continued to show a achievable greater threat of loss of life in patients obtaining Ukoniq. As a result, we established the hazards of cure with Ukoniq outweigh its benefits. Primarily based upon this dedication, the drug’s maker, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the accepted employs in MZL and FL.
Wellness treatment experts must end prescribing Ukoniq and switch patients to alternate remedies. Advise individuals presently getting Ukoniq of the greater hazard of death seen in the clinical demo and recommend them to end using the medicine. In constrained conditions in which a affected person may be acquiring advantage from Ukoniq, TG Therapeutics options to make it available under expanded accessibility.
Clients really should talk to your health treatment pros about option therapies and cease using Ukoniq. It is best to dispose of unused Ukoniq using a drug take-back site these kinds of as in a pharmacy, but if one particular is not accessible, you can dispose of Ukoniq in your home trash by carrying out the subsequent:
Mix the medication with an unappealing compound these kinds of as grime, cat litter, or used espresso grounds do not crush them.
Spot the mixture in a container such as a sealed plastic bag.
Toss absent the container in your household trash.
Delete all private facts on the prescription labels of vacant medicine bottles or packaging, then throw absent or recycle them.
We urge health care experts and patients to report aspect consequences involving medications to the Food and drug administration MedWatch system, using the data in the “Contact FDA” box at the base of the page.
Health treatment pros, people, and individuals can signal up for e mail alerts about Drug Safety Communications on medicines or health-related specialties of desire to you.
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By Taylor Knopf, NC Health News & Aneri Pattani, Kaiser Health News
DURHAM, N.C. — An addiction treatment facility, highly regarded by North Carolina lawmakers, sits in a residential neighborhood here and operates like a village in itself. Triangle Residential Options for Substance Abusers, better known as TROSA, hosts roughly 400 people a day on a campus with rows of housing units, cafeterias, a full gym and a barbershop.
The program, which began in 1994, is uniquely designed: Treatment, housing and meals are free to participants. And TROSA doesn’t bill insurance. Instead, residents work for about two years in TROSA’s many businesses, including a moving company, thrift store and lawn care service. Program leaders say the work helps residents overcome addiction and train for future jobs. Of those who graduate, 96 percent of individuals remain sober and 91 percent are employed a year later, the program’s latest report claims.
Impressed with such statistics, state lawmakers recently allotted $11 million for TROSA to expand its model to Winston-Salem. It’s the largest amount in the state budget targeted to a single treatment provider and comes on the heels of $6 million North Carolina previously provided for its expansion, as well as $3.2 million TROSA has received in state and federal funds annually for several years.
Keith Artin is the president and CEO of Triangle Residential Options for Substance Abusers, better known as TROSA. The program provides free treatment, housing and meals to residents who work for about two years in one of TROSA’s many businesses, including a moving company, thrift store and lawn care services. Photo credit: Taylor Knopf
This latest influx of taxpayer dollars — coming at a time when overdose deaths are surging and each dollar spent on treatment is crucial — is drawing criticism. Advocates, researchers, and some former employees and participants of TROSA say the program takes advantage of participants by making them work without pay and puts their lives at risk by restricting the use of certain medications for opioid use disorder. Although those who graduate may do well, only 25 percent of participants complete the program — a figure TROSA leaders confirmed.
“If I had known about this funding, I would have been the first person on the mic to [tell lawmakers], ‘I don’t think you all should do this,’” said K.C. Freeman, who interned at TROSA in 2018 and later spent two months on staff in the medical department. “You can’t look at the small number of people who had success and say this works. It’s not the majority.”
The dispute over TROSA’s funding comes amid national conversations about how to allocate billions of dollars available after landmark opioid settlements with drug companies. Two flashpoints in the North Carolina debate may provide a window into heated conversations to come. First: Are work-based rehabs legal or ethical? And second: Should every facility that receives public funding allow participants to use all medications for opioid use disorder?
Work as treatment
Work-based rehabs are widespread across the country. The investigative news outlet Reveal identified at least 300 such facilities, including some that place participants in dangerous jobs at oil refineries or dairy farms with no training and exploit workers to bolster profits.
Many of these programs use a portion of their revenue to sustain the rehab and offer residents free housing or meals. That can make them attractive to state legislators, said Noah Zatz, a UCLA law professor who specializes in employment and labor law.
“Because essentially they’re running businesses off of people’s uncompensated labor, there is a built-in funding mechanism,” he said. “If the state doesn’t have to pay full freight to run a program … that might be a reason to like it.”
TROSA’s annual reports indicate more than half of its multimillion-dollar budget is funded through its businesses at which residents work, as well as goods and services that are donated to the program. About 30 percent of its funding comes from government grants and contracts.
Although TROSA and its leaders report no significant campaign donations, they spend upward of $75,000 a year on lobbying. In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 million annually in criminal justice and emergency care costs.
The program’s self-financing aspect is part of its appeal for North Carolina Sen. Joyce Krawiec, a Republican who represents part of Forsyth County, where TROSA is building its new site.
“The good thing about TROSA: They raised most of their own funds,” she said in a phone interview.
Benjamin Weston decided to enter TROSA at 22 years old after struggling with addiction for years. He worked in TROSA’s development office soliciting donations from local businesses after stints in the project’s thrift store and moving company. Photo credit: Aneri Pattani/KHN
It’s reasonable that residents don’t get paid for their work, she added, since they’re already receiving free treatment and housing. Other rehabs can be prohibitively expensive for many families, so TROSA provides a much-needed option.
But being a bargain doesn’t necessarily make it legal, Zatz and other labor experts said. A previous U.S. Supreme Court ruling suggests nonprofits that run businesses without paying employees could violate the Fair Labor Standards Act.
But TROSA administrators say they are not an employer; they are a therapeutic community. Clear policies guard against the exploitation of anyone, said Keith Artin, president and CEO. The jobs provide residents with structure and an opportunity to change their behaviors.
“The work-based element is essential to recovery,” Artin said. “We’re teaching people how to live.”
Toward the end of residents’ two-year stays, TROSA assists them in job-hunting and allows them to live on campus for several months while they work at a newfound job and build savings.
Diverging work experiences
TROSA’s model has widespread support among lawmakers and families affected by addiction. Benjamin Weston said it was “a blessing.”
Weston said he started using cocaine as a teenager and struggled with addiction for years. At 22, he entered TROSA. He said he was grateful for two years of free treatment.
After brief assignments in TROSA’s thrift store and moving company, Weston transitioned to the development office, where he solicited donations from local businesses. “It was meaningful work that also taught me a lot of good job skills,” he said.
Since graduating in 2016, Weston has worked in development for Hope Connection International, a nonprofit his mother started to support survivors of abuse and addiction.
Other graduates interviewed for this article talked about using the moving skills or commercial driving licenses they gained to obtain full-time jobs. Some said they’re buying houses and starting families — successes they credit to their experience in the program.
But not every resident finds the work model therapeutic. Several described working 10 to 16 hours a day, six days a week, in physically demanding moving or lawn care businesses. Several said there was little time for therapy and, with only a handful of counselors for hundreds of residents, wait times for a session could span weeks.
Richard Osborne (right) with his girlfriend, Britney Robbins (left) and their son. Osborne said he was injured while working with TROSA’s moving company in 2017. He said nobody suggested he get medical care and that he was told to go back to work the next day. “They’re taking advantage of people at their low points in life,” he says. Photo courtesy of Britney Robbins
Freeman, the former TROSA employee who has a master’s in social work, said he thought residents rarely had an opportunity to process the trauma that made them use drugs in the first place. Although Freeman did not counsel clients — his role at TROSA focused on ordering and stocking medications — he said he noticed many graduates returned repeatedly to the program, struggling to stay away from substances once they left campus.
Richard Osborne first heard of TROSA while incarcerated on drug and theft-related charges. Like 38 percent of TROSA residents, he chose to attend the program as a condition of his probation.
One day in 2017, Osborne and other residents working with the moving company were unloading large boards of plywood from a trailer, when a board fell and smashed him against the trailer, he said. His vision became blurry and he worried about having a concussion, he said.
As he remembers it, no one suggested medical care. “The next day, they told me I had to get back to work,” he claimed.
That’s when Osborne said he decided to leave.
Today, Osborne, 31, said he has not used drugs in about four years, holds a steady job, and has a loving family. But it’s no thanks to TROSA, he said.
“They’re taking advantage of people at their low points in life,” he said. The moving company brings in $4 million a year, yet residents who work for it are not even allowed to keep tips, he added.
TROSA leaders confirmed the tips policy but said they could not comment on an individual residents’ experience. In general, CEO Artin wrote in an email, “when a resident is injured we ensure that they receive immediate medical attention and would never knowingly put a resident at risk.”
As a nonprofit, TROSA funnels revenue from its businesses back into the treatment program, he added.
The program’s 2020 tax documents show its top five employees combined earned over $750,000 in salary and benefits.
Medication hesitancy
TROSA provides psychiatric care through a contract with Duke Health and offers group or individual counseling to residents who request it. The program employs four full-time counselors and partners with local providers who donate physical therapy, dental care, and other medical services.
But TROSA does not provide access to some of the most effective treatments for opioid use disorder: methadone and buprenorphine. Both medications activate opioid receptors in the brain and reduce opioid withdrawal and cravings. It’s been well documented that these medications greatly reduce the risk of opioid overdose death, and the FDA-approved drugs are considered the “gold standard” for treatment.
Right now, TROSA leaders say the only medication for opioid use disorder the program offers is naltrexone, an injectable medication that works differently than the other two because it requires patients to fully detox to be effective. Because of this, some experts are hesitant to use it, saying it puts people at higher risk of overdose death.
About one-third of TROSA participants report opioids are their primary drug of choice.
TROSA leaders said they’ve discussed adding the other addiction treatment medications but face logistical barriers. All medications at TROSA are self-administered, and leaders worry about diversion of oral methadone and buprenorphine, which are classified as controlled substances. They say they’d consider injectable buprenorphine, but it’s costly for their mostly uninsured participants.
“People choose to come here because it is a behavior modification program,” said Lisa Finlay, lead clinical counselor at TROSA. “They know that we don’t offer buprenorphine or those medications. We have people who have tried those medications in the past and believe that they actually led them back to using.”
Evidence suggests that people using medications for opioid use disorder have the best outcomes when they have access to other recovery support services, such as housing, employment, counseling and a community. But while clinicians across the country have embraced these medications, leaders of residential treatment programs founded in the more traditional 12-step, abstinence-based recovery model have pushed back.
Some old-school recovery leaders claim the use of medications is simply replacing one drug with another, which has created stigma around this form of treatment.
A 2020 study found that about 40 percent of residential programs surveyed in the U.S. didn’t offer opioid use disorder medications and 20 percent actively discouraged people from using them. In North Carolina, there are 62 licensed long-term residential treatment facilities, according to the SAMHSA treatment locator, and fewer than half accept patients who take these medications. Only 12 facilities are licensed to prescribe buprenorphine.
This has resulted in tough conversations with patients for Kate Roberts, a clinical social worker on a UNC Health team that treats people with severe IV drug-related infections. Once patients are stabilized, many start buprenorphine, she said. Some say they want to go to a residential program for structure, job training and to learn coping skills. Roberts recalled one patient saying to her: “I need to go to residential treatment and I need this medication because I fear I’ll die.”
“That’s really heartbreaking to hear a patient clearly articulate what it is that they need … which is in line with the [research] literature,” she said. “And that you know there are very few places in the state that offer that.”
Doctors and public health experts nationwide are pushing for lawmakers to fund rehab facilities that allow these medications, saying they’re the best way to combat the opioid crisis.
Some medical and legal experts have said it’s in violation of the Americans with Disabilities Act to deny recovery services such as housing to people using medications for opioid use disorder. Health experts say that funding abstinence-based addiction programs could also inadvertently cause more overdoses if people leave the program and return to using drugs with a much lower tolerance, especially as fentanyl is rampant in the street drug supply.
These conversations will become only more important as opioid settlement funds arrive, said Bradley Stein, director of the national Rand Opioid Policy Center.
“The goal isn’t just to get people into treatment; it’s to get people doing better,” he said. “You want to make sure that you’re using the money effectively.”
The conversations have begun in North Carolina. When Rep. Graig Meyer (D-Durham) tweeted his support for TROSA late last year, clinicians reached out to him explaining their concerns about the program not allowing participants to use methadone or buprenorphine.
Although Meyer still believes it’s an effective program, he said, “I also have concerns from what I learned about TROSA’s approach to treating opioid addiction in particular. I’d like to see TROSA consider what their current practices are.”
North Carolina Health News is an independent, nonpartisan, not-for-profit, statewide news organization dedicated to covering all things health care in North Carolina.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs atKFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
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by Taylor Knopf, North Carolina Health News April 6, 2022
The North Carolina attorney general’s office had “great concerns about how HCA was selected” as the purchaser of the Mission Health System, including that “the deck had been stacked in its favor from the beginning” by then-CEO Ronald A. Paulus and his advisor Philip D. Green, according to a 2018 internal document obtained by Asheville Watchdog.
“[W]ith no outside advice other than Phil Green,” whom the investigators wrote had an undisclosed “prior business relationship with HCA,” Mission Health’s board of directors decided not to issue requests for competitive bids or to hold an auction before agreeing to sell Asheville’s flagship hospital system to HCA Healthcare for $1.5 billion, according to the document, prepared in advance of a meeting between Department of Justice lawyers and HCA representatives on Oct. 30, 2018.
Instead, as Paulus “coached HCA behind the scenes on how to best present its case to the Mission Board,” the board invited only one other healthcare company — identified in other documents as Novant Health of Winston-Salem — to present a formal offer.
“In the end,” the document stated, “an outside observer could conclude that HCA rose to the top among a limited number of bidders because the deck had been stacked in its favor from the beginning by Dr. Paulus and Mr. Green.”
The attorney general’s office was so concerned about potential conflicts of interest by Paulus and Green that it requested the Mission board revote on the transaction, the attorney general’s deputy chief of staff, Laura Brewer, wrote to Asheville Watchdog this week. After considering the information, the Mission board voted again, unanimously, to approve it.
Paulus did not respond to Asheville Watchdog’s requests for comment. Green declined an interview request but noted that the attorney general, after an extensive review, did not object to the sale.
Only HCA, Novant, and Atrium Considered
The Oct. 30 document, written by Special Deputy Attorney General Jennifer T. Harrod, who led the North Carolina Department of Justice investigation, was among more than 6,000 records released Feb. 25 by the office of Attorney General Josh Stein in partial response to public records requests filed by Asheville Watchdog over the past two years.
The documents contain details not previously made public about the sale of the 133-year-old nonprofit hospital system, including that, other than HCA and Novant, Carolinas HealthCare System (now Atrium Health) was the only other healthcare company that the Mission board seriously considered. But Carolinas was rejected quickly and not even invited to make a presentation to the board, the records show.
The documents confirm and expand on Asheville Watchdog’s previous reporting on the role played by Paulus and Green. They show Green negotiated proposed term sheets — nonbinding proposals — for both a $1.5 billion sale of substantially all of Mission’s assets to HCA and for a $650 million joint venture with HCA that would have preserved some local control. HCA provided Paulus with a written affiliation proposal on Aug. 12, 2017, six weeks before the Mission board authorized Paulus to engage in calls and meetings with potential affiliation partners.
Overall, the newly released documents raise serious questions about the role of Paulus, Mission’s president and CEO; his longtime personal friend and advisor Green; and the 18-member Mission board of directors, which investigators said seems to have accepted HCA’s arguments about cost-savings and improved quality of care “uncritically.”
Paulus’s emails examined
Under state law, the attorney general has the right to review any transaction in which a nonprofit corporation sells substantially all of its assets. The investigation of the proposed Mission deal began in May 2018.
By October 2018, Harrod and other lawyers in the attorney general’s office had examined thousands of documents related to Mission’s decision to sell, including Paulus’s and Green’s email exchanges with HCA and other potential partners, and minutes of Mission board meetings.
On the afternoon of Oct. 30, 2018, Harrod, at least two other lawyers with the North Carolina Department of Justice, and four representatives of HCA met at the attorney general’s office in Raleigh. No one from Mission attended,the records show.
“We see that HCA’s purchase of Mission brings something new and dynamic to the region,” Harrod wrote in an opening statement. She said the Department of Justice investigators had met the previous week with the chairman and vice-chairman of Mission’s board, who talked “about how much HCA’s efficiency, commitment to patient care, and sophisticated data analytics impressed them.”
“At the same time,” she continued, “we have great concerns about how HCA was selected to be the entity that purchased Mission.”
“Here are the facts as we currently understand them,” Harrod wrote:
Paulus and Green “steered the process by which other bidders were identified. Mission decided, with no outside advice other than Phil Green, not to put out a request for bids or hold an auction.”
Green had “a prior business relationship with HCA” that “was never disclosed to the Mission board.”
When Mission’s board members visited HCA headquarters, “Dr. Paulus and Mr. Green both thought it was critically important for Mr. Green to attend that meeting to ensure its success.”
“Dr. Paulus coached HCA behind the scenes on how to best present its case to the Mission Board. On two occasions, he pointedly told HCA that Mission’s peers were and would favorably consider being acquired by HCA.”
Paulus discussed his continued role with potential buyers. One wanted him to be chief information officer. “Later, that partner was dropped from consideration on grounds that appear pretextual to us … Reading his email exchanges with HCA, an outside observer could conclude that he was working hard to demonstrate his value to HCA,” the memo states. (Just days after the Mission sale closed, Paulus announced he was joining HCA as a strategic advisor. Tax records show Paulus received more than $4 million for his final four months at Mission. The terms of his employment agreement with Mission and hisconsulting job with HCA remain unknown. A spokeswoman for HCA’s North Carolina Division said Paulus is no longer a strategic advisor to HCA.)
“Neither the board nor its advisors seems to have given any thought to the fact that certain transaction partners offered Dr. Paulus greater scope for advancement versus others or versus no transaction at all,” Harrod wrote.
“In our opinion, Dr. Paulus’s conduct violated the Mission conflict of interest policy, which requires an officer or board member with even a potential conflict to not merely recuse himself from voting on the matter, but also from advocating for an outcome. Dr. Paulus offered to recuse himself, but was advised that it was unnecessary. The rationale was that since all of the potential partners wanted Dr. Paulus to continue in some capacity, therefore he had no conflict of interest.”
“Just have to trust HCA”
Harrod had already expressed concerns to Mission that the terms outlined in the Letter of Intent (LOI) negotiated by Paulus and Green did not go far enough in protecting the public’s interests.
“Given Mission Health’s strong operating and financial position, we believe Mission should be well positioned to negotiate for strong terms to protect public health interests, as has been done in other similar transactions,” she wrote to Mission officials on Aug. 8, 2018.
Philip D. Green, Mission’s strategic advisor
Instead, on Aug. 30, 2018, HCA and Mission signed an official contract, called the asset purchase agreement (APA), on terms the attorney general’s office believed favored HCA.
“Dr. Paulus and Mr. Green were principal negotiators of the APA,” Harrod wrote in her memo in advance of the Oct. 30, 2018 meeting. “It appears to us comparing the terms of the LOI to the terms of the APA, HCA improved its position considerably.”
“One of the major inducements for Mission to enter the LOI with HCA was thepromise that hospitals and services would be maintained,” Harrod wrote. “We and others advised Mission prior to signing the APA, that such commitments needed to be specific and measurable in order to be enforceable.”
“The emails we have seen demonstrate that Dr. Paulus ultimately buckled in the face of resistance from HCA and decided that Mission would just have to trust HCA,” she wrote.
Harrod wrote, “Even now, the board believes that HCA has committed to maintaining the current level of services … even though the APA says no such thing.” For example, the agreement allowed HCA to eliminate some services and close facilities if they became “commercially unreasonable,” documents show.
Harrod also wrote that “Mission agreed to let HCA use its existing charity care policy, even though it appears to us that for most patients, they would be much better off under Mission’s policy.” Weeks earlier, lawyers for both HCA and Mission had written to Harrod that HCA’s charity care policies were “more generous in most respects” than Mission’s policies.
HCA’s $188 Million Settlement
In January 2017, six months before beginning discussions with Paulus and Green, HCA agreed to pay $188 million to settle litigation over its failure to abide by the terms of its purchase of nonprofit Health Midwest hospitals in the Kansas City area, a transaction similar to its later deal with Mission Health.
In a letter Sept. 10, 2018, Harrod asked Mission senior vice president Donald R. Esposito to “[d]etail the assurances Mission has received that HCA will honor its contractual obligations, in light of its failures to do so in connection with its acquisition of Health Midwest.”
In her document for the Oct. 30, 2018 meeting, Harrod stated: “Despite the experiences of the health care foundation in Missouri, Mission agreed to dispute resolution terms that overwhelmingly favor HCA.”
“These are examples, not an exclusive list,” Harrod concluded.
“The best possible deal”
The attorney general’s investigation intensified over the next two months and included ensuring that Mission’s board knew about Green’s prior business relationship with HCA.
“We requested that the board be fully informed of this relationship and then take another vote on the deal,” Brewer, the deputy chief of staff, told Asheville Watchdog this week. “We also ensured that Mr. Green would not receive any compensation dependent on closing of the transaction, including any ‘bonus’ or ‘success fee,’ and that neither he nor his company would otherwise benefit from the transaction.”
The Mission board held special sessions Dec. 13 and Dec. 20, 2018, and Jan. 8, 2019, to discuss final details of the pending deal, including the findings of Harrod’s investigation.
In the end, Mission Board chairman John R. Ball wrote, in a letter to Stein after the Jan. 8 meeting, that the board considered the attorney general’s concerns and “concluded that Mission’s management team and its outside advisors were committed at all times to securing for Mission the best possible transaction with potential merger partners, ultimately leading to the transaction with HCA.”
“No member of Mission’s management or its advisors took any action, or failed to take any action, that was detrimental to Mission’s interests,” Ball wrote.
The Mission board, Ball wrote, “believes it has been, and remains fully informed with respect to all these issues,” and was “steadfast” in its goal to close the sale to HCA. The board’s re-votewas once again unanimous.
Ball could not be reached for comment.
Letter of Non-Objection
In an August 2021 interview with Asheville Watchdog, Stein said state law limited his authority to halt the sale despite the information uncovered by his investigation. Because of the law’s restrictions, Stein said, he sought specific enforceable agreements, a number of concessions from HCA, and 15 additional conditions to be added to a revised asset purchase agreement.
NC Attorney General Josh Stein
Stein’s conditions included the hiring of an independent monitor to oversee HCA’s compliance with the agreement; enforceable commitments to maintain current levels of service at all six hospitals in the Mission system, not for the five years Paulus and Green negotiated in some cases, but for 10 years; and requiring HCA to adopt what he viewed as Mission’s more generous charity care obligations.
Stein also got HCA and Mission to agree that the attorney general could enforce the terms of the contract.
On Jan. 16, 2019, Mission and HCA agreed to the attorney general’s changes and signed an“amended and restated”asset purchase agreement. Harrod then informed them that the attorney general would not object to the sale.
Green: “Concerns were baseless”
Green declined to speak with Asheville Watchdog but emailed a statement. “The Attorney General, after reviewing thousands of pages of documents and conducting an inquiry into ensuring a fair process and the absence of any conflict of interest, concluded that any concerns were baseless and wrote a Non-Objection letter,” he wrote.
The letter of non-objection, written by Harrod, actually said the Attorney General’s investigation had identified “potential concerns.” But, it said, “Mission Health has represented to the Attorney General that … no one on Mission’s board and no one responsible for advising Mission’s board will receive any direct or indirect benefit as a result of the sale of the operating assets of the Mission Nonprofit Entities to HCA.”
Green is still listed as an independent advisor for large healthcare mergers and acquisitions and has a consulting company based in Arlington, Virginia. Paulus is still a principal of RAPMD Strategic Advisors, based in Asheville.
Update From Stein’s Office
Harrod, who led the investigation into the Mission-HCA sale, is no longer with the Attorney General’s office. She declined to comment for this story.
In a statement to Asheville Watchdog last week, Brewer, Stein’s deputy chief of staff, wrote, “Under North Carolina law (unlike in many other states), the Attorney General’s authority in these kinds of deals is quite limited” to ensuring a fair purchase price and “that the charitable mission of the non-profit is being carried forward.”
“North Carolina law does not give our Office the general authority to police health care transactions based on how they would impact patients, quality of care, rural access, and other issues,” Brewer wrote. “Even though the Attorney General’s legal authority over this type of transaction is quite limited, we succeeded in negotiating a number of significant improvements to the agreement.”
“Paying More and Getting Less Care”
HCA officially took control of the Mission system on Feb. 1, 2019.
Novant,the lone other bidder that Mission’s board rejected in favor of HCA’s $1.5 billion offer, went on to sign a $5 billion deal, including $2 billion in cash, to acquire a smaller and less profitable hospital in Wilmington.
The Attorney General’s office denied Asheville Watchdog’s request for a comparison of Novant’s and HCA’s offers for Mission, citing state statutes that exempt confidential business information from public records requests.
Ashton W. Miller, Novant’s manager of public relations, declined to comment.
In the statement she prepared for the Oct. 30, 2018 meeting with HCA representatives, Harrod wrote: “We understand that HCA plans to do further acquisitions in North Carolina. This may not be the last time we are across the table from each other.”
Last week, when Asheville Watchdog asked what lessons were learned from the Mission sale, Attorney General Stein responded:
“Too often, when one hospital swallows up another, patients end up paying more and getting worse care. North Carolinians need better safeguards to review transactions to put the patients’ interest first. I’m working with partners in the legislature now to determine how our laws can better protect patients in these health care transactions.”
Asheville Watchdog is a nonprofit news team producing stories that matter to Asheville and Buncombe County. Peter H. Lewis is a former senior writer and editor at The New York Times. Email [email protected]. Sally Kestin is a Pulitzer Prize-winning investigative reporter. Email [email protected].
Asheville Watchdog gratefully acknowledges the assistance of the Duke University School of Law’s First Amendment Clinic, with special thanks to Danielle Siegel, Alexandria Murphy, Ben Rossi, and Dillon Farnetti.
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by Asheville Watchdog, North Carolina Health News March 20, 2022
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