“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
A Northern Kentucky pain doctor, who also was the owner of Kentucky Derby horses “Fast and Accurate” and “Hansen,” has been named as a defendant in a personal injury lawsuit.
But Dr. Kendall Hansen defended his practice in an interview with The Enquirer Thursday. He spent decades building his reputation, he said.
The lawsuit, filed in Kenton County Circuit Court, accuses Hansen and Interventional Pain Specialists of Crestview Hills of providing unnecessary and excessive injection therapy to an Independence woman with chronic pain.
One day later, federal officials served a search warrant at his office.
“We welcome the scrutiny,” Hansen said.
Eric Deters, spokesman of Deters Law ( http://deterslawfirm.com ) in Independence, said the woman who filed suit, Candi McKinney of Independence, is one of many who were treated unnecessarily with epidurals.
“(Hansen) would not give individuals their pain medication … unless they capitulated in having an epidural,” Deters said Thursday.
“We’re suspicious of people who only want medication and don’t want to get better. Whatever was said between me and the patient” was twisted, Hansen claimed.
Deters said that he was asked to put any clients in contact with the U.S. Drug Enforcement Administration and that he did so. However, he added that he did not know of any particular outcome.
Tim Reagan, resident agent-in-charge of the Cincinnati office of the DEA, said DEA officers were with federal agents at Interventional Pain Specialists for the search but his agency was not leading the search.
Hansen said he believed the search was a result of heightened scrutiny after one of his former nurses was caught stealing medication. Hansen said he reported the nurse to the DEA and local law enforcement.
“I think there’s a big spotlight put on us because of the incident last year,” Hansen said.
He added that medical records were examined by investigators.
“If I was them I would do that,” he said of the investigators conducting the search. “It’s our government dollars at work. We’re an amazing office. We do our due diligence prescribing.”
Hansen said he doesn’t expect future searches.
“My lawyer contacted the director that’s overseeing this in Washington,” Hansen said, “and it will be several months before they come back to us if they have any issues, but we’re confident there won’t be any serious issues.”
McKinney’s lawsuit was filed by Dominick Romeo of Deters Law. Judge Kathy Lape was assigned the case, and a summons was issued for Hansen to answer the suit. Once he receives it, he’ll have 20 days to respond, court documents state.
McKinney claims in the suit that her pain therapy started on Feb. 12, 2014, when she was prescribed oxycodone and a nerve-root block injection at the office. She got the injection Feb. 26 of that year, her lawsuit says.
She was written another prescription for oxycodone on March 26, the same year, the suit says, and then on April 15, she was told to have epidural injection therapy and her pain medication was increased, the suit claims.
“At least once a month, Plaintiff would undergo injection therapy and would be written a prescription for narcotic pain medication,” the suit states. She said she was afraid that if she didn’t undergo the “recommended injection therapy, her pain medication would be withheld from her.”
The suit also claims that McKinney asked about receiving Narcan, the antidote for opioid overdoses, because she already had prescriptions for a fentanyl patch and Percocet. Both of these are synthetic opiates that are commonly prescribed for pain.
The treatment continued until September 2018, the suit says, and that’s when she first saw Hansen and was given a new prescription for pain medication.
She saw Hansen Oct. 2, and medication was refilled, the suit claims. On Nov. 27, she says, Hansen recommended she undergo injection therapy again.
But she didn’t want an injection, the suit claims, and so Hansen “would not fill” her medication after Dec. 1, 2018.
She says in her suit that the injections caused “great pain and suffering due to the fact that they required pre-testing with probes on both sides of her spine” before she would get them.
Hansen said Interventional Pain Specialists treats about 4,000 patients and employs about 60 people.
The office performs about 50 different procedures, and roughly 10 percent of all procedures are of the “epidural variety,” he said.
The office’s philosophy is to perform procedures “to solve pain problems so (patients) are not so dependent on pain medication,” Hansen said.
He added he’s never been accused in this manner.
Other federal law enforcement agents did not return calls for comment.
I can’t remember the times that I have stated that “forcing” a pt to get ESI in order to get a Rx for oral opiates is a violation of a section of the Sherman Antitrust Act ( Tying Commerce) https://en.wikipedia.org/wiki/Tying_(commerce) which basically states that forcing a customer to purchase something that they don’t want in order to be able to purchase something that they do want.
The medication typically used in ESI’s is Depo-Medrol (Methylprednisolone) is NOT RECOMMENDED for use in ESI’s by both the FDA and Pfizer. So one can come to the conclusion that giving ESI’s with this medication is NOT MEDICALLY NECESSARY/APPROPRIATE.. Thus – in theory – any physician giving a pt ESI’s using this medication could be guilty of INSURANCE FRAUD..
***This video is the formal plea from 9 people (Susie Meneely, Reva Parker, Heidi Hines-Shattuck, Bree Wilson, Dawn Anderson, Cherie Sandretzky, Jessie Ray & *Suzanne Stewart (*the producer & editor of this video) who are also living with chronic pain. This is a very short piece of their stories and a very big plea to the News media, the Government of the USA and anyone else who may be able to help us. In 2016, the CDC wrote a set of guidelines (in secret without any real pain physicians present) for the prescribing of opioid pain medications. These meds have helped to relieve some chronic pain for humans for centuries. They have somehow turned into “Laws” in all of the 50 states. People who live with multiple chronic pain illnesses are now dying and/or committing suicide due to untreated or under-treated chronic pain. Please share this video with people who might be able to help us. I received the full videos from each of these women. I exited all of our stories and pleas. Please know that I invited all men and women living with the results of these CDC Guidelines. These are the persons who responded to my own pleas to make a video and send it to as many as possible who may be able to listen and help all chronic pain patients. Thank you for Watching!
This death was most likely preventable :'( this makes me so angry inside. On my very first pain mgmt. visit I first had to meet with a pain psychologist who had carefully and meticulously reviewed my medical file. One of his opening questions to me was, “Has any health care professional ever stated or made you feel like all this pain was in your head?” I said, “Well, yes I have been made to feel that way before.” And he said, “Well, that stops here. I’ve read your file over the last few days and what caught my attention was an ER report from April. You do know you were treated poorly for the first 10 minutes or so correct?” And I said, “To be honest, I was in so much pain I can hardly recall, I was not in a good frame of mind.” He said, “I see here, your blood pressure upon arrival was 220/165, after 5 more minutes it was even higher, is that correct?” I said, “Yes. I remember being taken to a room on a wheelie bed, the lights above me blending together, blurry. Voices sounded far away and my ears were ringing.” He said, “They did a blood lab prior to treating you, are you aware of this?” I said, “No.” (An IV was started right as I entered a room, no idea about a blood draw). He proceeded to inform me that even though I had an extensive history of failed back surgeries, they checked for illegal drugs before treating you. Umm, I found his information interesting but didn’t let it bother me until later. You see… I had had 3 major back surgeries and suffered horrendous pain that would cause what is now on my chart as “Hypertensive Crisis Pain Disorder” which I now know can escalate blood pressure so high that it can cause organ failure, heart attack, stroke, etc… my rapid blood screen came back with Tylenol #3 and Flexeril in it, which is what I was prescribed at the time. The ER Dr. was smart though and ordered IV 1.5 mg/ 2 hrs Dilaudid and oral 10 mg Valium (1 dose). That doctor treated me fairly once the initial assessment was taken of my blood. I realize they need to know what you’re on, but I was communicating, albeit not well, but in writing just fine. After the IV saline, Dilaudid and valium I was feeling better within 25 minutes and significantly better after an hour. They kept me 4 hours and the doctor wrote on my chart, “Highly recommend patients file be expedited to the waiting list at the pain clinic, she’s been waiting 6 months on the waiting list, she needs medication therapy for pain, life-threatening, she’s only 29 years old.” The psychologist assured me that pain CAN and HAS killed many people including: soldiers at war, shock and trauma patients and chronic pain patients. He said, “Your suffering stops here. You will not be treated like an addict, you have been suffering and this could damage your heart, kidneys, liver, brain, bodily function.” I’m so thankful that I picked a hospital that is the only accredited one in our state for treating pain. I continue to pray that I never lose treatment, as I could easily become a statistic – dead from lack of proper medical care.
This pseudo opioid crisis needs to STOP! The real crisis is the illegally manufactured designer street drugs and that is where nearly all of the DEA’s focus SHOULD be. They continue to perpetuate the stigma that opioids kill people… and forget blindly to say, “illegal illicit opioids are killing people, not prescriptions from legal doctors!” Ugh :/ I get so upset. No real chronic pain stories are told. We are soft easy targets who have a hard enough time getting dressed, let alone fighting against lawmakers, liars, the CDC’s bogus mme guidelines, etc.. no c.p.p. wants to be in pain, no one wants to take medicines, but just as a diabetic needs insulin some of us have pain disorders which require adequate care under the guidance of very knowledgeable teams of doctors.
This death ought to be investigated and scrutinized with a fine tooth comb. She probably died from heart failure due to going beyond the human threshold of pain based on the dels units scale ~65 del=death from shock, organ failure, etc… Lastly, the medications legally prescribed by doctors are MADE for a reason, they are not made for just ‘anybody’ they serve a very valuable purpose. Those patients who require medication mgmt. from pain that can kill you is why they were made. It shouldn’t take a rocket scientist to understand this. All pain patients I’ve been honored to talk with all have to “prove” they have pain nowadays. It is awful that this woman died, could’ve been me back in 2010, if that ER doctor had refused. :'( Why do we have to fight for adequate care? There needs to be a pain patients bill of rights and a compassionate care bill enacted. It’s the illegal druggies, dealers, and manufacturers that NEED to be arrested and given lengthy prison terms. Pain patients want to live, we want to be taken seriously. We only want legal options, not illegal. We don’t want to be high. We just need our medication health plan, which should be private but hell it’s not. HIPAA for a pain patient? Nope, not with all the databases. It’s ridiculous! This is a crisis: the refusal of proper care. :'( There needs to be a compassionate care law in place for c.p.p.
Thank you to anyone who read this long post, thank you to anyone helping to preserve a small quality of life for us who suffer. Thank you to anyone willing to reach out, speak up, fight, etc… it can be seen as a catch 22, damned if you don’t speak up about the abuse of not receiving proper care and damned if you do people who have never had any chronic pain in their damn life think you’re a drug addict :/ This.Has.To.Change. The media has influenced the general public with a false narrative. Even the CDC has admitted to wrongdoing, their calculations were WAY OFF! The number of deaths from opioids in 2017 was ~78,000 initially, but after careful review the number dropped by over 70% because they had combined illegal drug overdoses, illegal use of drugs, including mixing of other drugs like alcohol in with medications, etc… the likelihood of a c.p.p. dying of an overdose is less than 1%. The data is out there, it needs to be relayed appropriately.
Now I’m going to shed tears for the woman who died, even though I didn’t know her, I understand her struggle and that could’ve been me.
Anyone can become a c.p.p. at any time, due to an accident, severe injury, illness, etc… how would they like to be treated after they’d exhausted all options, including invasive procedures and surgeries? Can’t people at least think with more empathy, “What if that was me? What if that was my daughter, my son, my father, my mother, my child, my baby?” Think.People.Think! One day it could be you.
When the Illinois Board of Pharmacy meets, Philip Burgess, national director of pharmacy affairs at Walgreens wag, the Illinois-based firm that’s the nation’s largest drugstore chain in sales and profits, chairs the sessions.
Michael Podgurski, vice president of pharmacy services for Rite Aid, rad leads pharmacy board meetings in Pennsylvania, the headquarters of the East Coast’s largest pharmacy chain.
Bob Dufour, the former director of pharmacy services for Arkansas-based Wal-Mart wmt, chairs that state’s board.
Kay Hanson, the pharmacy regulatory affairs manager for Target tgt, serves on the board in Minnesota, the firm’s corporate base. And James DeVita, CVS’ cvs quality assurance director, is on the Massachusetts board.
The five executives aren’t the only retail chain pharmacists who serve on the state panels assigned to oversee prescription drug safety for the American public. A USA TODAY examination shows employees of major drugstore chains or supermarket pharmacies accounted for nearly one in four of the 295 pharmacists on the panels this year.
The appointments give consumers the benefit of the pharmacists’ expertise. But they also give the chains a network with potential say about decisions that affect the pharmacy industry.
Most chain pharmacists abstain from votes that have a direct impact on their firms. DeVita, for instance, didn’t vote on a 2005-06 investigation of CVS prescription errors, records show. But USA TODAY’s examination, which included a survey of pharmacy boards in the 50 states and the District of Columbia, plus court and government records and information from the firms, found potential or alleged conflicts:
•Two Walgreens pharmacists on Florida’s board opposed the maximum fine for another Walgreens pharmacist who failed to catch a prescription error that led to a construction worker’s death.
•Before retiring from Wal-Mart in 2007, Dufour took part in discussions and votes on a cost-saving system for filling prescriptions that could benefit retail pharmacies, including Wal-Mart.
•In Nevada, where chain representatives hold four of the six pharmacist seats, the lone member representing the public heads an advocacy group that represents chain pharmacies. She recuses herself from disciplinary matters involving those firms, prompting a complaint that state residents have been deprived of a voice.
•At this year’s convention of the National Association of Boards of Pharmacy, an independent organization that helps the state panels develop uniform standards, a chain pharmacy industry group spent more than $21,000 on a reception for pharmacy board delegates.
“The chains aggressively seek as much representation on the boards as they possibly can,” says Daniel Hussar, a pharmacy professor at Philadelphia’s University of the Sciences and editor of the Pharmacist Activist newsletter.
Burgess testified in a 2007 court deposition that Walgreens encourages its pharmacists to seek board seats because “it’s very important for our employees to be actively engaged with their professional associations and their boards of pharmacy.”
Who serves
Hussar says he’s concerned the chains could “promote individuals who have a high loyalty” to their employers — rather than to consumers — for the posts.
Pharmacy chains and an industry group representing them dispute any such conclusion. “Members of pharmacy boards serve as advocates for public safety, not as representatives of their employers,” says CVS spokesman Michael DeAngelis, echoing Walgreens, Rite Aid and Wal-Mart.
“Pharmacists consider it an honor to serve on their board. They make decisions that impact people’s lives. It is their duty to protect public health and safety — and they uphold that duty with the utmost sincerity and responsibility,” says Chrissy Kopple, a spokeswoman for the National Association of Chain Drug Stores.
The chains say pharmacists use their own judgment on board issues. But Walgreens spokesman Michael Polzin says the firm’s pharmacists on the panels may ask for background “on an industry issue the board is debating … and we may supply it.”
Noting that most oversight boards include active practitioners, Polzin adds that “someone who practices the profession will be a more valuable resource.” More pharmacists work for chains than for any other employer, so “it should not be surprising that they are selected to serve on state boards of pharmacy,” Kopple says.
Pharmacy board members, typically appointed by state governors, are assigned to protect public health and safety in the dispensing of prescription drugs. Pharmacists comprise the majority of each board, but the panels also include non-pharmacists appointed to represent the public.
Although duties vary from state to state, the boards typically license pharmacies and pharmacists, set training standards, oversee pharmacy inspections and hold disciplinary proceedings for alleged safety violations.
As drugstore chains grew, their pharmacists have won dozens of board seats. USA TODAY documented that network, finding that Walgreens and CVS, the two largest chains, are tied for the most with at least 21 seats each.
States require board members to obey conflict of interest regulations. But USA TODAY’s review of board records, meeting minutes and interviews — which followed February stories that showed pharmacies’ policies can contribute to prescription errors — found potential conflicts.
In June 2005, Florida’s pharmacy board held a disciplinary hearing for Tonya Pearson, a Walgreens pharmacist in Jacksonville. She was accused of failing to catch a dosage-instruction error on a methadone prescription for Terry Paul Smith, a 46-year-old roofer who was prescribed the drug for pain relief.
The error was made by a pharmacy technician who typed the prescription into a Walgreens computer. Smith died of an overdose within 36 hours after getting the prescription.
During the Florida hearing, Gail Merrell, the Walgreens pharmacist who chaired the panel, said her employment would not “affect my ability to render judgment,” a hearing tape shows. Albert Garcia, a board member who also worked for Walgreens, made a similar statement.
As the panel deliberated penalties, board member Eric Alvarez, a pharmacist not affiliated with Walgreens, made a motion to impose the $10,000 maximum state fine. “At least this record would show that this board would be sympathetic to the consumers in the state of Florida, which we’re sworn to protect,” he said.
But the motion failed for lack of a seconding vote. Merrell, saying she disagreed with the maximum penalty, proposed a $500 fine, the hearing tape shows.
“I think that a misfill by a pharmacist is their worst nightmare, and we’ve had many people before the board who’ve had misfills. And I really believe that education is the key here — getting the pharmacist to rethink his steps and to re-educate them,” Merrell said.
The board compromised, fining Peters $1,000 and requiring her to complete an education course on avoiding errors. Merrell and Garcia voted with the 5-1 majority, with Alvarez dissenting.
“All I could do was kind of get into my car, and cry, and beat the steering wheel and scream out obscenities,” said Smith’s widow, Pearl, who attended the hearing and recounted her reaction in a subsequent interview. She called the votes of the Walgreens pharmacists, who declined to discuss the case, “a definite conflict.”
Florida guidelines, however, say board members only face a conflict by acting on matters involving a “special private gain” for them or for “a principal by whom the member is retained.”
Nonetheless, Walgreens spokesman Polzin says the firm’s pharmacists should have recused themselves from the Peters hearing “to avoid even the appearance of a conflict of interest.”
Walgreens had no contact with the pharmacists about the hearing, he says.
Workload pondered
During the last two years, the Arkansas Board of Pharmacy weighed a regulatory change that would authorize retail pharmacies to fill prescriptions using a so-called off-site entry process. When a pharmacist in one store is busy with many prescriptions, such systems enable a pharmacist in another store to help with the workload via computer.
Walgreens and Wal-Mart requested the changes, pharmacy board records show. Dufour, the board’s chairman and at the time, Wal-Mart’s director of pharmacy services, recused himself from a 2006 vote that extended a pilot project to test whether off-site entry systems could increase prescription errors.
But board minutes show he joined in the unanimous June 2007 vote that approved a new regulation authorizing an off-site entry system in retail pharmacies.
Charles Campbell, the board’s executive director, says Dufour properly abstained from voting on extending the pilot project because it directly involved Wal-Mart. Dufour’s votes on the final approval and other steps “were on motions that applied broadly to the retail pharmacy industry and not solely to Wal-Mart,” says Campbell, adding, “I see no reason why he should have recused from those votes.”
Dufour did not return an e-mail message seeking comment.
In Nevada, pharmacists employed by Walgreens, CVS, Wal-Mart and Albertsons hold four of the six board seats designated for pharmacists. The relative under-representation of independent pharmacists “does create an appearance problem,” says Larry Pinson, the board’s executive secretary. However, he says it’s difficult to get candidates from Nevada’s small roster of non-chain drugstores.
The lone Nevada board member designated as the public representative of the state’s residents is Mary Lau, CEO of the Retail Association of Nevada. Her organization represents businesses across the state, including chain pharmacies. To avoid conflicts of interest, Lau has repeatedly abstained from votes that directly affect the association’s pharmacy members since she joined the board in late 2007. But that procedure has raised new questions.
“In most cases, she recuses (herself from voting), so it’s essentially like not having a public board member,” Pinson says. “I suppose the question is, if I were a member of the public, would I feel as though I was being represented? If she has to recuse on everything, probably not.”
Khanh Pham, president of the Nevada Pharmacist Association, filed a 2008 complaint with the state ethics commission that said Lau “deprives … constituents of a voice” by abstaining.
“If you have a public member just sit there … what kind of service do you provide to the people?” Pham asked in a recent interview.
The ethics commission, however, dismissed the complaint for lack of jurisdiction. A spokesman for Gov. Jim Gibbons, who appointed Lau, did not return a message seeking comment.
Lau says she abstains only when the board considers disciplinary matters involving a specific pharmacy represented by the retail association. Other board members safeguard the public’s interest when she can’t participate, she says.
“I bring a very strong perspective from the public side, because I know what pharmacy should do when it is working properly,” Lau says.
Tradition rules
During the annual convention of the National Association of Boards of Pharmacy last May, hundreds of state board delegates nibbled spring rolls and sipped cocktails during a reception in Baltimore’s Marriott Waterfront Hotel.
The $21,286 event — paid for by the National Association of Chain Drug Stores, whose members are regulated by the state boards — posed what one official called a potential ethics issue.
“We’ve tried to get rid of it … to avoid the conflict,” says Carmen Catizone, executive director of the National Association of Boards of Pharmacy. But, he adds, the reception is a “tradition.”
Disputing any suggestion of a conflict, Kopple, the industry group spokeswoman, notes that Catizone’s group is not a regulatory agency. “We’re pleased to support an effort that has all these pharmacists together looking out for the best interests of the nation’s patients,” she says.
Hussar, the pharmacy professor, says the tradition should end. “When it comes to a relationship between the regulators and the regulated, I really feel there has to be a separation,” he says.
The primary charge of the Boards of Pharmacy is to protect the health/safety of the general public, yet the vast majority of the boards will state that they have no legal authority to tell a permit holder how to run their business and a similar number see no relationship between the number of prescriptions/hr filled, the technician/pharmacist hours available and/or the technician/pharmacist ratio that is allowed by the board/state and medication errors – or mis-fills.
One has to ask the question if all of these non-practicing corporation pharmacists on these pharmacy boards are they really focused on protecting the health/safety of the general public or more interested in keeping their corporate employer happy with how they are doing their job on the board ? This lawsuit by this pharmacist would suggest that the latter may be the reality of it all.
The kids hanging around your local Walgreens may be buying more than candy.
Walgreens has the worst record among pharmacies regarding selling tobacco products to minors, the U.S. Food and Drug Administration said Thursday.
The Deerfield, Illinois-based pharmacy racked up about 1,800 violations for selling tobacco products to kids across the United States. That means about 22 percent of Walgreens stores inspected have illegally sold the products to underage customers, per the report.
“I will be writing the corporate management of Walgreens (NASDAQ: WBA) and requesting a meeting with them to discuss whether there is a corporate-wide issue related to their stores’ non-compliance and put them on notice that the FDA is considering additional enforcement avenues to address their record of violative tobacco sales to youth,” FDA Commissioner Scott Gottlieb said in a statement.
The administration has taken action with a Walgreens store in Miami and is seeking to bar the the store from selling any tobacco products for 30 days. The FDA has already sent more than 1,550 warning letters and 240 civil monetary penalty actions against Walgreens stores in the U.S. for selling the products to minors.
An estimated 4.9 million middle and high school students reported current (past 30 days) use of any tobacco product in 2018, according to preliminary results of the 2018 National Youth Tobacco Survey.
An epidemic-level rise in e-cigarette use over the last year has also led overall tobacco product use to increase by 38 percent among high school students (to 27.1 percent) and by 29 percent among middle school students (to 7.2 percent) in the last year, reversing the declines seen in the last few years.
Companies are starting to sell “risk scores” to doctors, insurers and hospitals to identify patients at risk of opioid addiction or overdose, without patient consent and with little regulation of the kinds of personal information used to create the scores.
While the data collection is aimed at helping doctors make more informed decisions on prescribing opioids, it could also lead to blacklisting of some patients and keep them from getting the drugs they need, according to patient advocates.
Over the past year, powerful companies such as LexisNexis have begun hoovering up the data from insurance claims, digital health records, housing records, and even information about a patient’s friends, family and roommates, without telling the patient they are accessing the information, and creating risk scores for health care providers and insurers. Health insurance giant Cigna and UnitedHealth’s Optum are also using risk scores.
There’s no guarantee of the accuracy of the algorithms and “really no protection” against their use, said Sharona Hoffman, a professor of bioethics at Case Western Reserve University. Overestimating risk might lead health systems to focus their energy on the wrong patients; a low risk score might cause a patient to fall through the cracks.
No law prohibits collecting such data or using it in the exam room. Congress hasn’t taken up the issue of intrusive big data collection in health care. It’s an area where technology is moving too fast for government and society to keep up.
“Consumers, clinicians and institutions need to understand that personalized health is a type of surveillance,” says Harvard University professor Eric Perakslis. “There is no way around it, so it needs to be recognized and understood.”
The justification for risk scoring is the terrible opioid epidemic, which kills about 130 Americans a day and is partly fueled by the overprescribing of legal painkillers. The Trump administration and Congress have focused billions on fighting the epidemic, and haven’t shied from intrusive methods to combat it. In its national strategy, released Thursday, the White House Office of National Drug Control Policy urged requiring doctors to look up each patient in a prescription drug database.
Health care providers legitimately want to know whether a patient in pain can take opioids safely, in what doses, and for how long — and which patients are at high risk of addiction or overdose. Data firms are pitching their predictive formulas, or algorithms, as tools that can help make the right decisions.
The practice scares some health care safety advocates. While the scoring is aimed at helping doctors figure out whether to prescribe opioids to their patients, it might pigeonhole people without their knowledge and give doctors an excuse to keep them from “getting the drugs they need,” says a critic, Lorraine Possanza of the ECRI Institute.
The algorithms assign each patient a number on a scale from zero to 1, showing their risk of addiction if prescribed opioids. The risk predictions sometimes go directly into patients’ health records, where clinicians may use them, for example, to turn down or limit a patient’s request for a painkiller.
Doctors can share the patients’ scores with them — if they want to, the data mongers say. “We stop really short of trying to advocate a particular opinion,” said Brian Studebaker from one of the risk scoring companies, the actuarial firm Milliman.
According to addiction experts, however, predicting who’s at risk is an inexact science. Past substance abuse is about the only clear red flag when a doctor is considering prescribing opioid painkillers.
But several companies POLITICO spoke with already are selling the predictive technology. None would name customers. Nor would they disclose exactly what goes into the mathematical formulas they use to create their risk scores — because that information is the “secret sauce” they’re selling.
Congress has shown some interest in data privacy; a series of hearings last year looked into thefts of data or suspect data sharing processes by big companies like Facebook. But it hasn’t really delved into the myriad health care and health privacy implications of data crunching.
Consumers have a “basic expectation” that the data they provide to websites and apps “won’t be used against them,” said Sen. Brian Schatz (D-Hawaii), who co-sponsored legislation last year barring companies from using individuals’ data in harmful ways. The HIPAA privacy law of the late 1990s restricted how doctors share patient information, and Schatz says “online companies should be required to do the same.”
A bill from Sen. Ed Markey (D-Mass.), S. 1815 (115), would require data brokers to be more transparent about what they collect, but neither his bill nor Schatz’s specifically address data in health care, a field in which separating the harmful from the benign may prove especially delicate.
The use of big data in this arena impinges on human rights beyond simple violation of privacy, says data governance expert Martin Tisne. He argues in a recent issue of Technology Review for a Bill of Data Rights that includes the right to be secure against “unreasonable surveillance” and unfair discrimination on the basis of data.
Risk scores may be ‘the way of the future’
Research into opioid risk factors is nascent. The University of Pittsburgh was awarded an NIH grant last year to determine whether computer programs incorporating Medicaid claims and clinical data are more accurate than ones based on claims alone.
Risk scores could be helpful if they help clinicians begin candid conversations about the unique circumstances that could make a patient more vulnerable to opioid use disorder, said Yngvild Olsen, a board member at the American Society of Addiction Medicine.
But the algorithms could be relying on inaccurate public data, and they may disempower patients, leaving them in the dark about the Big Brotherish systems rating them. Another key challenge, says Case Western’s Hoffman, is ensuring that the predictions don’t override a clinicians’ instinct or reinforce biases.
It’s difficult to imagine what a robust safeguard against the misuse of predictive algorithms would even look like, she said. One approach might be to revise health care privacy law to prohibit groups from profiting from health data or algorithms that crunch it. But that won’t keep tech companies from making predictions based on whatever they can access.
Algorithms predicting health risk are likely “the way of the future,” she said. “I’m afraid we need to learn to live with them. … but get more education.”
The companies using predictive analytics to address the opioid crisis include insurer Cigna, which announced last year it was expanding a program flagging patients likely to overdose. The insurer has a “number of tools that enable further insights,” Cigna’s Gina Papush said. Optum has also begun stratifying patients by opioids-related risk. It said a spokesperson was unavailable to comment.
Milliman won an FDA innovation challenge to create an artificial intelligence-based algorithm that predicts whether patients will receive an opioid use disorder diagnosis in the next six months. The company offers to provide a list of high-risk patients to payers, who can hand the relevant information to clinicians.
Milliman has signed early-stage contracts with some accountable care organizations. It assigns patients a risk score from zero to 1, and also compares them to other patients.
Another company, called HBI Solutions, uses a mathematical formula that learns from deidentified claims data, said senior vice president Laura Kanov. Payers or providers can run the formula on their own patient data. Unlike some companies, HBI displays the reasoning behind each risk score, she said.
LexisNexis sells health plans a tool that flags patients who may already have opioid use disorder. Someone could be at greater risk if their relatives or roommates abuse opioids, or if they use a pharmacy known for filling high volumes of pills, said LexisNexis’s Shweta Vyas. LexisNexis can draw “relatively strong connections” between people based on public records showing they live at the same address, she said. If both parties are enrolled in the same health plan, the software can find patterns “in the aggregate behavior of those two people.”
Sally Satel, an American Enterprise Institute fellow and psychiatrist, warned that risk scores could reinforce what she sees as a mistaken idea that doctors who overprescribe are the key drivers of the opioid crisis. A patient who’s been in a serious car accident could exceed the recommended duration of opioid use because of their mental and emotional state, not just because a doctor gave them too much, she said.
“I don’t know how much an algorithm can examine all those much more personal dimensions,” she said. “I’d love to see this being studied more, instead of being sold.”
Just imagine how accurate these “risk scores” are going to be when a fair/unknown number of fake ID’s are being used by serious substance abusers and/or diverters are thrown into the mix ?
Getting a fake ID package is readily available and we have been told that fake credit accounts are being opened and debit run up under with these fake ID’s
We already have companies that will sell you a service to watch your credit score– likehttps://www.lifelock.com – are we going to have a new industry evolve to watch and help straighten out this risk score.
Next time a centenarian tells an interviewer they’ve reached old age while smoking a pack of cigarettes a day, it won’t be a Hawaiian. That’s assuming a bill passes that would raise the smoking age on the archipelago to 100 by the year 2024.
The bill is the handiwork of state representative Richard Creagan, who told the Hawaii Tribune-Herald that existing taxes and regulations are not doing enough to defeat tobacco smoking. “This is more lethal, more dangerous than any prescription drug, and it is more addicting,” he said in an interview published Sunday.
“In my view, you are taking people who are enslaved from a horrific addiction, and freeing people from horrific enslavement,” he told the Tribune-Herald.
Creagan’s bill leaves electronic cigarettes, cigars, and chewing tobacco untouched. A separate state bill would raise the excise tax from 16 cents a pack to 21 cents. It will also mandate that the state uses the funds from the excise hike for health programs and research.
Hawaii already requires cigarette buyers to be age 21, in common with Boston and New York City, plus countries including Singapore, Honduras and Sri Lanka. If Creagan’s bill passes, Hawaii will join Bhutan and Turkmenistan in legislating near-total bans on tobacco smoking.
According to the state’s department of health, tobacco kills over 1,100 Hawaiians a year and costs $336 million in direct healthcare costs. It adds that smoking kills, “more people than alcohol, AIDS, car crashes, illegal drugs, murders and suicides combined.”
The Centers for Disease Control and Prevention (CDC) also says that cigarette smoking is responsible for more than 480,000 U.S. deaths per year, including 41,000 deaths resulting from secondhand smoking, equivalent to about one in five deaths in the country.
Guess what happened when Congress in 1914 passed the Harrison Narcotic Act??? It created the “black drug market” that Congress ended up passing the Controlled Substance Act 1970 to declare “war” on the illegal drug market.
If this bill passes and signed into law.. this should be interesting since the chain of islands has to import most all things that are consumed/used on the island. It is not a big push to realize that this is going to create a huge black tobacco market on the islands.
So is this going to be enforced by local/state police or will ATF (alcohol, tobacco, & Firearms) enforce this, but this is going to a state law not a federal law – YET !
I guess that the tobacco industry will have a “army of lobbyists” descending on the state legislature to try and stop this bill
Wisconsin’s two U.S. Attorneys have sent letters to 180 physicians, physician assistants and nurse practitioners in the state warning them that their opioid prescribing practices could result in prosecution.
None of the prescribers have been charged with a crime and it’s not clear if any are under investigation or have been linked to overdoses. Copies of the letters were not released and the recipients were not identified.
According to a news release, the letters warn doctors that they are prescribing opioids at “relatively high levels” that could lead to addiction and that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.”
“We know that for many, addiction began with opioids prescribed by a medical professional,” said Matthew Krueger, U.S. Attorney for the Eastern District of Wisconsin. “By sending these letters, we are asking medical professionals to join the fight against addiction and ensure they prescribe no more opioids than are necessary.”
“Opioid addiction has touched the lives of far too many families in our state,” said Scott Blader, U.S. Attorney for the Western District of Wisconsin. “Medical professionals play a pivotal role in stemming the flow of legal opioids into unlawful channels.”
According to a spokeswoman, the 180 recipients of the warning letters were selected based on a review of Medicare prescription drug claims, which found that they prescribed opioids above the CDC’s highest recommended dose of 90 MMEs (morphine milligram equivalent).
“They were identified through Medicare data for two years,” Myra Longfield, a public information officer in the Western District of Wisconsin, told PNN. “And from that data, practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain.”
The 2016 CDC opioid guideline is voluntary and only intended for primary care physicians. Longfield said warning letters were not sent to pain management physicians, oncologists or those working in hospice or palliative care, where higher opioid doses may be needed to control pain.
Chilling Effect on Prescribers
Federal prosecutors in Georgia and Massachusetts have sent similar warning letters to high prescribers. While the intent is to urge caution, critics say the letters are likely to intimidate other doctors.
“This will have a totally chilling effect. The abuse of statistics is pathetic. It would only be an ignorant person that would take the top prescribers and say that they are endangering lives,” said Mark Ibsen, MD, a Montana doctor who nearly lost his medical license over allegations that he overprescribed opioids.
“After they lop off the top prescribing doctors, guess what that leaves? More top prescribing doctors. Until there are none. Soon we will be seeing tattoos on physicians, similar to POWs.”
“This is an egregious overreach and will lead to more deaths not fewer,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Using the CDC guidelines as a goal post is not what even the CDC recommended. Most opioid addictions do not begin with a legal prescription of opioids. It usually starts long before exposure to a prescription opioid. The major problem is with illegal opioids smuggled in from Mexico and China.
“I am worried for tens of thousands of patients in Wisconsin. Many of them will be at risk of suicide or seek illegal drugs, where the real harm exists. Sad. Very Sad.”
Last year, the American Medical Association adopted resolutions opposing the “misapplication” and “inappropriate use” of the CDC guideline. The resolutions by the AMA House of Delegates warn that “no entity should use MME thresholds as anything more than guidance” and that physicians should not be disciplined or prosecuted for prescribing opioids at levels above those recommended by the CDC. The AMA said some patients “can benefit from taking opioids at greater dosages” and “such care may be medically necessary and appropriate.”
Most opioid overdoses in the United States are now linked to illicit fentanyl and heroin, not prescription opioids. In Wisconsin, 916 people died of opioid overdoses in 2017. Most of those deaths involved either heroin or fentanyl.
It just keeps getting worse. That’s a major finding of an AMA survey of 1,000 practicing physicians who were asked about the impact prior authorization (PA) is having on their ability to help their patients.
More than nine in 10 respondents said PA had a significant or somewhat negative clinical impact, with 28 percent reporting that prior authorization had led to a serious adverse event such as a death, hospitalization, disability or permanent bodily damage, or other life-threatening event for a patient in their care.
PA, a health plan cost-control process, restricts access to treatments, drugs and services. This process requires physicians to obtain approval prior to the delivery of the prescribed treatment, test or medical service in order to qualify for payment.
Traditionally, health plans applied PA to newer, expensive services and medications. However, physicians report an increase in the volume of prior authorizations in recent years, to include requirements for drugs and services that are neither new nor costly.
The vast majority of physicians (86 percent) described the administrative burden associated with prior authorization as “high or extremely high,” and 88 percent said the burden has gone up in the last five years.
“The AMA survey continues to illustrate that poorly designed, opaque prior authorization programs can pose an unreasonable and costly administrative obstacle to patient-centered care,” said AMA Board of Trustees Chair Jack Resneck Jr., MD. “The time is now for insurance companies to work with physicians, not against us, to improve and streamline the prior authorization process so that patients are ensured timely access to the evidence-based, quality health care they need.”
“The AMA is committed to attacking the dysfunction in health care by removing the obstacles and burdens that interfere with patient care,” Dr. Resneck added. “To make the patient-physician relationship more valued than paperwork, the AMA has taken a leading role by creating collaborative solutions to right-size and streamline prior authorization and help patients access safe, timely and affordable care, while reducing administrative burdens that pull physicians away from patient care.”
The AMA offers prior-authorization reform resources that allow physicians to make a difference with effective advocacy tools, including model legislation and an up-to-date list of state laws governing prior authorization.
Other highlights of the AMA physician survey include that:
91 percent believe that PA delays patients’ access to care.
75 percent reported that PA can lead to patients abandoning their course of treatment.
The AMA survey was conducted online in December 2018. Participants were physicians who practice in the United States, provide at least 20 hours of direct patient care and complete PAs during a typical week of practice. Forty percent of participants were primary care physicians, and 60 percent were in other specialties.
Physicians’ views on the impact of care delays comes into focus when one considers the typical turnaround times they see from health plans.
In the AMA survey:
65 percent of physicians said they wait an average of one business day for a prior-authorization decision from a health plan.
26 percent reported waiting at least three days.
7 percent reported waiting an average of more than five days.
Physicians in the survey reported processing an average 31 PAs per week, with this PA workload consuming 14.9 hours—nearly two business days—of physician and staff time.
Additionally, 36 percent reported that their practice has staff who work exclusively on PA.
In January 2017, the AMA with 16 other associations urged industry-wide improvements in prior authorization programs to align with a newly created set of 21 principles intended to ensure that patients receive timely and medically necessary care and medications and reduce the administrative burdens. More than 100 other health care organizations have supported those principles.
In January 2018, the AMA joined the American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association and Medical Group Management Association in a consensus statement outlining a shared commitment to industry-wide improvements to prior authorization processes and patient-centered care.
I can’t remember the times that I have stated that “forcing” a pt to get ESI in order to get a Rx for oral opiates is a violation of a section of the Sherman Antitrust Act ( Tying Commerce) https://en.wikipedia.org/wiki/Tying_(commerce) which basically states that forcing a customer to purchase something that they don’t want in order to be able to purchase something that they do want.
