“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
The link below is to the 33 page 9-0 decision and the text in this blog post is a synopsis from someone else. I have said for years that a potential solution to the war on pts by the DOJ/DEA… would involve law firms and lawsuits. It is not often that SCOTUS comes out in a 9 to 0 opinion. This is very interesting:The Justice Department said it should be an objective standard, not up to each doctor’s whim.It appears that the DOJ has been using a UNDEFINED standard of care and best practices – and the DOJ used some OBJECTIVE STANDARD in treating SUBJECTIVE DISEASES. I have stated before that the DEA was requiring a practitioners to produce TESTS that OBJECTIVELY PROVES the intensive of the pt’s pain. It would also pertain to treating depression & anxiety – other subjective diseases. I am no attorney, but since this was just referred back to the appeals court – that made the decision – the SCOTUS rejected 9-0. Doesn’t mean that the appeal court will not find a “new reason/excuse” to reinstate the previous convictions of these two practitioners. Perhaps the appeal court finds these two practitioners INNOCENT and I guess that double jeopardy applies, but the DOJ may find a “new violation of the CSA” and go back after these two practitioners… After all, it is claimed that anyone taken to federal court – 90%+ are found guilty. These two cases, if left as not guilty, will mess with the DOJ winning percentages.
Supreme Court Rules for Doctors on ‘Pill Mill’ Prosecution Proof
The case is Ruan v. United States, Kahn v. United States, U.S., Nos. 20-1410, 21-5261, 3/1/22.
The US Supreme Court sided with doctors seeking a higher burden of proof in prosecutions for distributing controlled substances like opioids.
In a unanimous decision on Monday, the justices rejected the government’s attempt to make it easier to convict physicians it alleged acted more like drug dealers in prescribing pain killers.
The ruling stemmed from two separate cases prosecuted under the federal Controlled Substances Act for unlawfully prescribing opioids and other controlled substances. Registered professionals are exempt if they prescribe drugs for legitimate medical purposes in the usual course of practice.
The justices vacated the appeals court decisions affirming the convictions and sent the cases back for further review.
The issue was what the government has to prove when it comes to criminal intent. The defendants argued they subjectively believed they were prescribing in good faith.
The Justice Department said it should be an objective standard, not up to each doctor’s whim.
In delivering the opinion of the court, Justice Stephen Breyer said the government must prove beyond a reasonable doubt that the defendant knew that he or she was acting in an unauthorized manner, or intended to do so, after a defendant produces evidence that he or she was authorized to dispense controlled substances.
“Defendants who produce evidence that they are ‘authorized”’ to dispense controlled substances are often doctors dispensing drugs via prescription,” he said. “We normally would not view such dispensations as inherently illegitimate; we expect, and indeed usually want, doctors to prescribe the medications that their patients need.”
Xiulu Ruan, 59, was convicted in Alabama and sentenced to 21 years in prison for running what the government called a “massive pill mill” with a co-defendant in Mobile. Shakeel Kahn, 55, was convicted in Wyoming and sentenced to 25 years for running an enterprise with his brother that the government said targeted addicts and resulted in a patient’s death.
Justice Samuel Alito filed a concurring opinion, which Justice Clarence Thomas joined and Justice Amy Coney Barrett joined in part. While Alito said he would toss out the lower courts’ decisions and remand the case for further proceedings, he said the Controlled Substances Act should be read to preserve a traditional preponderance-of-the-evidence standard.
I love math issues… let’s look at this example .. Medicare pays for how many doses of 20 mg or 40 mg ?
I checked onwww.goodrx.comin my zip code lowest available price # 30 doses 20mg $0.25 each $ 7.42 & 40 mg $0.13 each $3.89
Cost Plus Drug Co.#30 @ $.019 =5.70 + 1.01 (15% profit) + $3 dispensing fee + $5.00 delivery fee =$14.71
I checked our Humana Part D and #30 esomeprazole 20mg $16.50 ($.55 each) – no coverage for 40 mg
since no strength or quantity was provided in the article, both strengths seem to be less expensive using www.goodrx.com It would appear that pharmacy dispensing fee, 15% profit margin & $5 shipping fee .. turns their price stated as in PENNIES ..turns into DOLLARS TOTAL COST. There are other cash discount cards like single care and others.
Cuban’s estimated Medicare cost – unless that is the cost that the PBM charges Medicare after paying the pharmacy and adding all their administration fees, could be true, but could possible point out how crooked the PBM industry is and why they are paying multiple million files for over charging various entities – mostly Medicare & Medicaid.
The truth is, when Congress passed the Medicare Part D & Medicare Advantage med bill, they turned this medication program for Medicare folks to FOR PROFIT INSURANCE COMPANIES and/or PBM companies, which are licensed insurance companies. Congress agreed that they would not allow Medicare to negotiate prices. The PBM industry for the last 50+ yrs have been extremely opaque on how their financial charges are determined. The Insurance/PBM industry has one of the largest pots of money to lobby Congress and this might explain why Congress handed the medication for Medicare folks to this FOR PROFIT INDUSTRY and Medicare agreed not to try to negotiate a discount/lower price on covered medications…. that was back in 2003 +/- Part D program became active Jan 1, 2006.
‘Let’s get this done,’ Mark Cuban tells Biden on Medicare savings study
Medicare recipients could have saved up to $3.6 billion on generic drug costs in 2020 if Medicare paid the same prices as investor Mark Cuban’s pharmacy, according to a study published June 20 in Annals of Internal Medicine. Mr. Cuban tweeted the results, urging President Joe Biden and other elected officials to “have your people call my people and let’s get this done.”
The pharmacy, Mark Cuban Cost Plus Drug Co., has quickly gained speed from about 100 generic drugs at its launch in January to more than 700 generic drugs six months later.
The researchers from the Program on Regulation, Therapeutics and Law at Boston-based Harvard Medical School and Brigham and Women’s Hospital identified 89 generic drugs for which they could compare prices between Mark Cuban Cost Plus Drug Co. and Medicare Part D plans.
If Medicare Part D plans matched Mr. Cuban’s prices for 77 of the 89 generic drugs, 37 percent of Medicare’s $9.6 billion 2020 drug costs could have been slashed, the study found. Twelve drugs did not cost less.
The researchers found the best results with esomeprazole, a drug that treats acid reflux heartburn, which could have saved CMS up to $293 million if Medicare paid the same amount as Cost Plus Drug Co. Medicare paid $1.77 per pill. Cost Plus Drug Co. gets it for $0.19.
Cost Plus Drug Co. sells its products with a $3 pharmacy dispensing fee, $5 shipping fee and a 15 percent profit margin.
“Our sole mission is to be the low-cost drug provider for as many drugs as we can possibly offer,” Mr. Cuban told Becker’s. “That is counter to most business interests, particularly over a long period of time.”
While working at one of the nation’s largest safety-net hospitals, I experienced first-hand how difficult it can be for people to access medical care. For many providers, the story of the patient with diabetes or a suspicious lump who couldn’t get an appointment in time or wasn’t able to take time off work will resonate all too well. Many hospitals have adopted initiatives to improve access, but innovation has been slow, confined to individual institutions, and hampered by regulation.
In the absence of a productive government, some believe it necessary to turn to industry. One industrial giant touting itself as the newest solution to healthcare is CVS Health. Its power unknown to many, CVS Health is a nation-wide conglomerate composed of 9,900 retail stores, which serves over 1 million customers a year through its senior pharmacy, runs 1,100 MinuteClinics, has 105 million plan members through its pharmacy benefit manager (PBM) Caremark, and manages health insurance for over 34 million people through traditional, voluntary, and consumer-directed health insurance products and related services, including Aetna. And now, CVS Health has unveiled its newest venture: primary care.
CVS Health wants to expand by transforming MinuteClinics into HealthHUB clinics, a one-stop-shop for primary care needs. Customers will be able to schedule primary care visits, browse CVS’s 6,000 branded medical products, and receive education on chronic disease management. On November 5, 2021, CEO Karen Lynch announced CVS Health would be hiring primary care physicians for their new HealthHUBs, a move which will make CVS Health the first company to offer physician patient care coupled with a pharmacy, covered through its own insurance plan, and managed by its own PBM.
Can such a vertically integrated, for-profit company deliver on its promise to increase access to high-quality care while lowering healthcare costs? With the majority (71%) of Americans living within a 5-mile radius of a CVS, the company is poised to deliver local, convenient primary care. However, the complexity of incentives in the integrated CVS Health model pose reasons to approach this new model with caution.
First, the relationship between a healthcare provider integrated with an insurance company has implications for how high-quality care can be incentivized. While providing high-quality care that keeps patients out of the hospital will lower costs on the insurance provider, incentives could also be skewed to keep patients from accessing costly services. Current insurance companies do this with utilization controls, such as gatekeeping, prior authorization requirements, and step therapy. In theory, stricter utilization controls at CVS Health could result in telehealth first and in-person visits restricted to HealthHUBs, leaving Aetna members with little choice in primary care services, and reliance on an unknown quality of new HealthHUB practitioners. Additionally, having providers employed by both an insurer and PBM could incentivize reduced referrals out-of-network, preventing patients from getting the care they need. Meanwhile, the company’s profits would likely offset any losses incurred from worsened patient health.
Second, complexities arise from the potential for induced demand. A provider service owned by a pharmacy could theoretically incentivize physicians to increase prescriptions, particularly those covered under the formulary negotiated by the PBM Caremark. While some may think physicians would not engage in such actions, multiple studies have shown that physicians, like all human beings, can be influenced by financial incentives.
Lastly, with an insurer providing care to its own patient population, it will be important to watch for any potential cream-skimming in which less healthy persons are de-incentivized to join the CVS Health plan. Cream-skimming has been widely reported in Medicare Advantage (MA) plans, and with a large portion of CVS’s 2020 revenue stemming from MA benefits, it will be important to keep an eye out for any additional cream-skimming tactics.
Some may argue that such profit tactics are worth tolerating if they reduce U.S. healthcare costs. One argument is that, with its 105-million-member strong network, the Caremark PBM could negotiate with manufacturers and providers to drive down drug and hospital prices. However, research has not shown that for-profit vertical integration will pass on cost savings to patients. Rather, the current PBM structure incentivizes formulary coverage of whichever drugs the PBM can negotiate the highest percent rebate on, with rebates passed off to the insurer or PBM rather than patients. In fact, a lawsuit is alleging that CVS Health denied consumers low-cost generic medications, choosing only to cover higher-priced brand-name drugs, which increased profits for their pharmacy and PBM, and cost patients higher co-pays. Therefore, it is very possible that patients will not see savings through increased vertical integration, and that the promises of integration-driven efficiency may just be another example of for-profit “health-washing.”
Is for-profit vertical integration the innovation the U.S. needs to increase access to quality care, deliver improved health outcomes, and lower overall healthcare costs? Despite incentives that could theoretically skew the company towards strict utilization controls, induced pharmaceutical demand, or cream-skimming, CVS Health has the potential to deliver on their promises by enacting tight internal controls.
The question then becomes: how will CVS Health be held accountable? Without transparency into CVS Health payment structures, quality measures, and health outcomes, the public will be left to question whether this new disruption will truly bring about the changes in primary care we have all been waiting for.
While the road ahead remains uncertain, one thing is clear: CVS Health is forcing traditional healthcare to adapt. One promising avenue may be state-wide global payment models, such as Accountable Care Organizations, that reimburse on value rather than volume. If the monopolization of privatized healthcare forces hospitals to accelerate their switch to such global payment models, then perhaps the public will glean benefits from the for-profit sector after all.
Lucia Ryll is a fourth-year medical student at Boston University School of Medicine, and a 2023 Boston University Questrom School of Business MBA Candidate.
this is some items included in a Narxcare report… IF you notice Narxcare – someone – has CREATED a LME (Lorazepam ) Lorazepam Milligram Equivalents – just the TIP OF THE ICEBERG in this reporting system – there is a WHOLE LIBRARY of 3 color informational handouts the practitioner can print out. Also notice that any – per CDC – that anyone taking more than 50 MME opiates should be prescribed NARCAN. there is all sorts of graphs included to give the practitioner viewing this report as much as a YEAR’S data on a pt… so that the practitioner can get a quick good/bad idea of the pt’s controlled substance use. Of course a LARGE BLIP in the middle of a graph covering the entire year may cause the practitioner to come to the wrong decision about the pt.
This appear to be a newer format and OVERDOSE RISK SCORE – the old format only had THREE SECTIONS – LOW-MED-HIGH over dose risk. Which was probably more useful and maybe more accurate than over the NINE DIFFERENT SCORES now used.
If you click on the images they will enlarge and be easier to read.
Also notice that any one taking 50 MME’s has – according to Narxcare a 25-85 higher potential ratio to OVERDOSE and anyone taking >90 MME’s has a automatically score of having a higher potential for OVERDOSING.
In Indiana – don’t know about other states – the Narxcare report is AUTOMATICALLY INCLUDED when a practitioner pulls up a PDMP (INSPECT) report.
We have been always been the UNITED STATES OF AMERICA… Our Constitution plainly states what is to be managed by the Federal gov and what is the responsibility of the states. We are not the 50 regional members of the North America Federalization Government.
This has been a interesting month for the bureaucrats in Washington DC.. SCOTUS decided that states could not prohibit USA citizen to own and bear arms, because it is guaranteed right by the 2nd Amendment of our Constitution. SCOTUS also declared that RED FLAG laws regarding confiscating a person’s gun(s) was unconstitutional.
Congress turned around and passed a new “gun law” making RED FLAG LAWS legal… I would presume that this law is going to handed to ATF… a “sister agency ” to the DEA… Both under the same Presidential Cabinet Seat of DOJ. Most of us are well aware of all the RED FLAGS that the DEA has created surrounding prescribing/filling controlled meds… and RED FLAGS are not mentioned nor defined in the controlled substance act, but that has not stopped the DEA from turning their opinions into RED FLAGS and then apply those RED FLAGS as to who has violated the CSA.
SCOTUS following their other opinion(s) of what is stated/defined in our Constitution, they declared that the 50 y/o SCOTUS decision that the right to a abortion is guaranteed by the federal government is not supported by our constitution and is neither guaranteed nor prohibited in our Constitution and sends the issue BACK TO THE STATES to dictate what is allowed/prohibited, in regards to abortion in individual state. NO SCOTUS did not make abortion ILLEGAL
My first thoughts, with up to a dozen types of birth control/contraception. Including Plan B/morning after (72 hrs) pill for those who have been raped or there is incest. I am sort of confused about the “my body, my choice”… what about personal responsibility ? I have seen stats of one million + abortions performed every year. Does that suggest one million + BAD DECISIONS “in the moment” ?
Personally, I am somewhere between agnostic and indifferent on the issue of abortion. The first question – after personal responsibility – One Million + abortions has got to involve some major $$$ of medical costs. Not to mention some of these females may end up with the need for some Psychological help when they later regret their decision.
I viewed a video from a female, probably in mid-late 30’s. Stating that she had a child when she was young and kept the baby and admitted that she was not a real good Mother to that kid… Then stated that “totally unexpected”, got pregnant again and had her first abortion in 2009. Here is 2022 and she stated that she was in her last year in her PharmD degree and she found herself pregnant again and the “sperm donator ” did not want to be a FATHER and she did not want to give birth during her graduation and it would ruin her career. Maybe, her first born was grown and left home and didn’t want to be a single Mother in her late 30’s and starting her career.
Obviously, she did not figure out how a pregnancy happened since apparently several years later was “totally unexpected” pregnant. I would hope by her 5th-6th yr of pharmacy school, she would have fair handle on how pregnancy happens and what contraceptives are available and how they work.
Maybe, as a country we should put vending machine .. right next the the ones that provide free Narcan, clean needles, etc, etc.. with free Birth Control pills, condoms , Plan B. Maybe be able to help prevent pregnancy rather than terminating pregnancies.
This past week, we had a LESS THAN FOUR YEARS OLD Whirlpool washer FAIL ON US.. We had purchased it from a local owned appliance store we have been patronizing for some 3+ decades. We used a repairman that they recommended – didn’t know at the time that this guy had worked for a local Whirlpool service center until it was closed and he went into business for himself. He told us that it was one of two boards – there was no error codes that would display and each board was $300-$400 each.. I contacted Whirlpool company customer service… they kept me on hold so long that I was able to search expected life span of such equipment – under HEAVY USE – EIGHT YEARS — under light use – 10-12 yrs… take a guess – TWO SENIOR CITIZENS is the only ones using this machine since it was purchased new and the anticipate life expectancy we should expect.
I was hoping that Whirlpool would provide the bad control boards and I would pay the labor… NOPE… I was told that I had to have THEIR APPROVED REPAIR SERVICE TO ASSESS THE MACHINE… I had already paid $75 for an evaluation from a person who use to work for Whirlpool – and working on appliances for FORTY YEARS – and I was going to pay for another service run with NOT EVEN A PROMISE/HOPE that they may provide some compensation on this machine or credit on getting a new Whirlpool washer…
The CS person seemed to be totally unconcerned… and my closing statement to him was that our new washer would not be a Whirlpool… I don’t know if he was chuckling under his breath, because after I went on line and found out all the different washing machine labels… they make… Maybe he sensed that I would not be “smart enough” to find out that information..
We contacted our locally owned appliance store that we have been using for 3+ decades and our NEW LG WASHER WILL BE DELIVERED TOMORROW !
It was at Massachusetts General Hospital that Bryan found the care he needed for his opioid use disorder. He had previously tried, without success, to just quit. But when the hospital’s renowned addiction medicine team prescribed him Suboxone, a medication that can tame cravings, it worked.
Bryan also had cystic fibrosis, which by 2017 had progressed to the point he needed a lung transplant. It made sense that he would get that done at MGH too.
The transplant team, citing the Suboxone Bryan took, rejected him.
The denial confounded Bryan and his family. Bryan was doing what he was supposed to be doing, taking an effective medication that other doctors at that very institution had put him on. It helped him live free of misused painkillers and heroin. But the denial was also an emergency. Bryan kept getting sicker.
“At that point, you realize you’re 27 and dying,” Bryan said, recalling how he thought he would miss out on the future life he had envisioned for himself. “You’re not going to give someone a chance because of the past they had when they were younger?”
An unexpected ally agreed with Bryan.
In a 2020 settlement, the U.S. Justice Department found that MGH discriminated against Bryan under the Americans with Disabilities Act, the landmark 1990 civil rights law meant to ensure that people with disabilities have the same opportunities as everyone else. It’s not a well-known element, but the law classifies substance use disorder as a disability, meaning disfavoring someone for being in recovery or based on their past drug use is illegal. (The law does not extend its full protections to people still using drugs.)
Increasingly, Justice Department attorneys are leveraging the law to try to overcome some of the rampant discrimination that people with substance use disorders face. The cases typically center on people who are penalized because they take medication for opioid addiction — treatments that are considered the gold-standard — and on people who are denied those medications, particularly in the criminal justice system. The underlying argument rests on the idea that imposing barriers on treatment for a disability is tantamount to doing so on the basis of the disability itself.
“We have so stigmatized drug use that it doesn’t even seem to register that what they’re saying is not OK.”
Kelly Dineen
Creighton University
The pace of the cases is picking up, with the government reaching agreements with or filing suit against institutions in Pennsylvania, Rhode Island, and Colorado in recent months. And in April, the Justice Department’s Civil Rights Division released guidance outlining how the ADA applies to substance use disorders, aiming to explain to people with addiction histories that they have rights they might not be aware of.
“We have so stigmatized drug use that it doesn’t even seem to register that what they’re saying is not OK,” Kelly Dineen, the director of the health law program at Creighton University, said about institutions that discriminate. The department’s actions, Dineen said, convey that “not only is it unethical, it’s unlawful.”
If anything, advocates say it’s an overdue enforcement of a law that’s been on the books for three decades, a policy that Justice Department lawyers have acknowledged they’ve only started wielding in recent years. But the hope is that what may seem like whack-a-mole investigations — a nursing facility that won’t take patients on Suboxone here, a detention center that won’t provide addiction medications there — will spark enough attention to motivate whole fields to change their policies, lest they want to duel with the Justice Department.
“The country’s top law enforcement agency has now stated plainly that denying health care and other vital services to people with opioid use disorder violates federal law,” said Sally Friedman, senior vice president of legal advocacy at the Legal Action Center. “So facilities like jails and skilled nursing facilities that routinely discriminate against people with opioid use disorder should see the writing on the wall, and that if they continue to discriminate, they shouldn’t be surprised when the Department of Justice comes knocking on their door or they get served with a lawsuit.”
Bryan, who asked to be identified by his first name only, ultimately got his transplant in November 2017 — at the University of Pennsylvania. As part of the settlement, on top of training transplant staff on the disabilities act, MGH had to pay $170,000 to Bryan and $80,000 to his mother, who stayed with him in Pennsylvania for six months as he recuperated.
In a statement, MGH said it “is committed to ensuring all its services, including organ transplantation, are available to all patients including those with disabilities. The MGH Transplant Center has ensured that all staff understand responsibilities under ADA.”
Packages of Suboxone, a treatment for opioid use disorder. Kristoffer Tripplaar/Sipa USA/AP
Listen to lawyers involved in these cases, and you’ll learn they’re not hard to find.
“This kind of discrimination is overt,” Gregory Dorchak, an assistant U.S. attorney in Massachusetts who has led many of these investigations, said on a recent webinar.
In 2018, the Justice Department first advocated for the legal theory that “discrimination on the basis of treatment is discrimination on the basis of disability,” Dorchak said. It came in an investigation of Charlwell House, a skilled nursing facility in Massachusetts that refused a patient who took Suboxone. Change the prescription, the nursing facility told the patient, and we’ll reconsider.
“Right there, you have, in that short message, essentially the smoking gun of the policy,” Dorchak said. “They articulate that, but for the medication being used, we would admit this person.”
The department reached a settlement with Charlwell House, under which the facility had to adopt a non-discrimination policy and provide ADA training. It has since reached agreements with about eight other skilled nursing facility organizations.
Such cases expose how many institutions — including health care facilities — don’t realize that withholding services from someone based on their addiction history or ongoing treatment amounts to illegal discrimination. It’s a result of both a lack of knowledge about ADA protections generally, and the specific stigma that people who’ve used drugs encounter, experts say.
“There is resistance to seeing those as medical conditions or disabilities,” Elizabeth Pendo, a professor of law at St. Louis University, said about substance use disorders. Instead, some people view them mainly as the ongoing consequences of bad decisions or lack of willpower. “Those misperceptions, those biases, those assumptions, they linger, and they’re harming people,” Pendo said.
“Those misperceptions, those biases, those assumptions, they linger, and they’re harming people”
Elizabeth Pendo
St. Louis University
The ADA considers as a disability any physical or mental impairment that substantially limits major life activities, or a history of such an impairment. Congress signaled that the definition should be interpreted broadly and the protections extended widely, legal scholars say. Under that framework, people in recovery from opioid and other substance use disorders have disabilities and can’t be discriminated against.
(There is an exception to the ADA’s protections: they do not extend to people who are currently using illegal drugs, meaning someone could lose out on a job, for example, for failing a drug test. However, there is an exception to that exception. Even people who are using drugs can’t be legally denied medical care — such as treatment for complications of injection-related infections — despite the fact that that happens frequently, experts say.)
These cases also highlight the discrepancy that exists between what’s considered standard-of-care treatment for opioid addiction and the perceptions of those therapies.
Two of the three approved treatments — buprenorphine (which Suboxone is a form of) and methadone — are opioids themselves. The medications are taken as controlled doses to overcome the misuse of other opioids and, in these patients, do not provide a high. Decades of research show they help control cravings, stave off withdrawal, enable people to live productive lives, and save lives. Some people take the medications for years, with experts likening it to using insulin to manage diabetes.
Still, some people maintain biases against the medications, thinking that taking them is not compatible with being in recovery — a perspective that the Justice Department now stresses can be discriminatory.
“The chief barriers to expanding MOUD access … are often based on misguided stereotypes and stigmas about the treatment and diversion concerns,” Dorchak and David Howard Sinkman, an assistant U.S. attorney in Louisiana, wrote in a recent paper, referring to medications for opioid use disorder. “Rooting out such unfounded fears is at the heart of the ADA.”
In other words, people are discriminated against for using medications that doctors have prescribed to help them stop using drugs in the first place. Forcing people off the medications can sometimes lead to people returning to illicit drug use.
While the U.S. attorney’s office in Massachusetts led many of the first ADA addiction cases, others are stepping up the pace. And in the past few months, the department has found that the Indiana state nursing board violated the ADA by effectively keeping a nurse who was on buprenorphine from getting her license; filed a lawsuit against Pennsylvania’s court system for allegedly denying people from participating in supervision programs if they were on certain medications; and won the right for people at a Rhode Island detention facility who were being treated for opioid addiction before entering the facility to stay on their medications.
As the Rhode Island and Pennsylvania cases show, the Justice Department is trying to use the ADA to expand access to medications in the criminal justice system, where only select facilities have embraced methadone and buprenorphine. As Sinkman and Dorchak wrote, “the vast majority of the nation’s jails and prisons ban the provision of lifesaving, FDA-approved, and doctor-prescribed drug treatment,” even as — as one 2007 study found — the risk of overdose death is 129 times higher for people in the first two weeks after being released from prison than that of other people.
In some cases, correctional facilities have argued they are compliant with the ADA because they offer inmates the third opioid addiction medication, naltrexone (also known as Vivitrol), which is not an opioid. But the Justice Department has asserted that institutions have the obligation to provide all three treatments, and that the decision of which treatment to use should be up to patients and their doctors, not jails or judges.
“These medications are not interchangeable,” Sinkman and Dorchak wrote. “One version of MOUD might work well for one patient but not another. This is why the ADA requires ensuring access to all three forms of MOUD in the criminal justice system.”
President George Bush signing the Americans with Disabilities Act on July 26, 1990. Barry Thumma/AP
The Justice Department is not the only agency responsible for enforcing the ADA. In 2018, for example, Volvo had to pay $70,000 to resolve a suit brought by the Equal Employment Opportunity Commission after it allegedly refused to hire someone for being on Suboxone. In May 2020, the federal health department reached an agreement with a West Virginia agency, after a couple was allegedly denied permission to adopt their niece and nephew because the uncle was on Suboxone.
The question remains whether these individual deals are having a broader impact — whether they’re influencing other institutions to change their policies before they feel the heat of a federal investigation.
It’s still early to gauge the ripple effects. In one study, researchers at Boston Medical Center found that the rate of discriminatory rejections by Massachusetts nursing facilities was the same after the first settlement in 2018 as it was before. But since then, as the government has continued to pursue such cases, “the settlements have led to growing recognition that this is something that can’t just be ignored,” said Simeon Kimmel, an addiction medicine and infectious diseases physician at BMC.
It’s not that there’s been a shift across the entire industry, Kimmel said. But some skilled nursing facilities have developed relationships with addiction treatment programs and now accept people on these medications, even if others still reject those patients when referred.
By establishing precedents, the initial cases can also open the door for future legal action, whether by the government or by advocates. Indeed, Justice Department attorneys have cited cases not brought by the government as guiding their work in this area.
In one, a federal court in 2018 found that a Massachusetts jail’s refusal to allow a potential inmate to stay on methadone violated the ADA. (The judge also raised constitutional concerns.) And in 2019, a different federal court ruled similarly in a case involving a Maine jail’s ban on buprenorphine.
“The ADA has always applied to jails and prisons, but that legal precedent is something people can point to and build on to say, judges are now saying this explicit denial is illegal,” said Rebekah Joab, a senior staff attorney at the Legal Action Center. “It’s really hard to assert these rights as an individual, but having those decisions on the books allows individuals to say to a jail or prison, look, a judge has said this is illegal, and also you don’t want to be sued.”
Rachael Rollins, who was sworn in as the U.S. attorney in Massachusetts in January, told STAT that she intended to promote widely the work that the office has been doing in this area. Attorneys have done presentations for a trade group representing nursing facilities about ADA protections, and Rollins said she hopes to do trainings with medical schools and associations.
“We can ring the alarm to say to people, don’t make us come and have to find you,” Rollins said.
A cup is filled with a dose of methadone at the San Francisco General Hospital Opiate Treatment Outpatient Program . Laura Morton for STAT
With his new lungs, Bryan is now living the life he feared he wouldn’t see. For most of his life, he was hospitalized twice a year as a result of his cystic fibrosis. He hasn’t been hospitalized in four years.
He’s still on buprenorphine, though now in the form of a long-acting injectable. He views his drug use as something in his past, and doesn’t think or talk about it much. He’s also experienced the stigma that comes with others viewing him as a drug user. All of that is why he asked to be identified by his first name only.
Bryan works as an engineer, and in the past year, has bought a house and gotten engaged.
“I couldn’t ask for a better life,” he said.
This story is part of a series on addiction in 2022, supported by a grant from the National Institute of Health Care Management.
From a short websearch – MO Healthnet – seems to be the state of MO Medicaid program. Will many of the practitioners in MO just pull out of the Medicaid program or will they end up just applying Medicaid prescribing rules to all their pts… so that they will not accidentally exceed the dosing limit on Medicaid pts ? with this and the other post from today that applies to SC and Arkansas New law lets South Carolina providers deny care that conflicts with personal beliefsIs it time for some law firms that deal with civil right violations to step up to the plate ?
Steve Corsi, Psy.D., Director of Department of Social Services Randall Williams MD, Director of Department of Health Mark Stinger, Director Department of Mental Health
This message is intended to reach the people listed above as the heads of their respective Departments. If they have since been replaced please forward it to the new Director(s). No disrespect to anyone else that may read this, but I need to reach those with the power to effect change. Since the website for the Great State of Missouri is extremely difficult to navigate, I am sending this to the address listed on the March 9, 2018 letter to prescribing physicians. At the end of this message I will attach the response that I have already received from the Administrator of the MO Bureau of Narcotics and Dangerous Drugs. In his letter he was clear that doctors should use their best medical judgement in prescribing and that the CDC Guideline does not hold the effect of law. What it has done is frightened physicians to the point of abandoning, forcing tapers and refusal to accept any new pain patients.
As you are well aware on March 9, 2018 physicians that accept MO HealthNet were issued a letter that can only be described as a direct threat to their livelihood, ability to properly treat patients, and even their freedom in the form of incarceration if they did not dramatically reduce the doses of chronic pain patients on opioids to an arbitrary amount of 90mmed. There is no medical evidence that this threshold in anyway protects the lives of chronic pain patients as we are the most responsible patients a doctor could have. It also discounts the fact that the enzymes in the livers of each individual metabolize opioids at extremely different rates so much so that a dose of 50mmed in one patient may suppress their pain, but another patient may require 1,000mmed or more to control the same amount of pain.
This has forced doctors in MO to taper their patients that have been on high dose long-term opioid pain medications, sometimes for decades, against the patients wishes and their thoroughly considered medical decisions. This has been disastrous for Missourians and across the country where this guideline has been applied as policy or law. Whether your intent was to force doctors to do this it has been the effect. My personal physician has received regular visits by the BNDD to monitor the tapering of opioids of legacy patients. It is impossible that an agency that denies this guideline has the force of law, would take it upon themselves to do these edits without being directed by one of your Departments.
Factors you may not be, but as a governing body should be aware of, is that the authors of the CDC Guidelines were from a radical group of anti-opioid crusaders known as PROP physicians for responsible opioid prescribing, or as many in the industry call them PROPaganda. (They will be mentioned again in this letter many times) In 2012 PROP petitioned the FDA, which is the appropriate regulating agency for prescription drugs in the United States, with the very recommendations they later used as the anti-opioid guideline. The FDA of course rejected their petition because it was not based on solid science. The FDA did agree with them in part and introduced new labeling requirements. Again this is the ONLY measure that was approved by the FDA, which again is the governing and regulating body for all prescription drugs. The buck stops with them.
In the published abstract from the authors of the guideline they readily admit they used low quality evidence as a basis for their recommendations and I quote… EVIDENCESYNTHESIS Evidence consisted of observational studies or randomized clinical trials with notable limitations, characterized as low quality using GRADE methodology. Meta-analysis was not attempted due to the limited number of studies, variability in study designs and clinical heterogeneity, and methodological shortcomings of studies. No study evaluated long-term (1 year) benefit of opioids for chronic pain. Opioids were associated with increased risks, including opioid use disorder, overdose, and death, with dose-dependent effects. IMPORTANCE Primary care clinicians find managing chronic pain challenging. Evidence of long-term efficacy of opioids for chronic pain is limited. Opioid use is associated with serious risks, including opioid use disorder
Underlined in the above information (top) provided directly by the authors of the guideline shows that they used poor quality studies to reach their conclusions. In the next underlined part (bottom) it is clearly stated that this information is directed SOLELY to Primary Care Physicians who may find treating chronic pain challenging. It is not intended to apply to ANY specialists, particularly those who specialize in diagnosis and treatment of chronic pain disorders. The bold and italic portion indicates the opinions of the writers with very limited scientific evidence. While some studies suggest an increased effect of mortality with higher doses, they are of the same limited numbers and poor quality. The bold portion indicates that there is limited evidence of long-term efficacy of treating chronic pain with opioids. This is due to the fact that an ethical clinician cannot take patients that have been treated long-term with high dose opioids and replace them with placebo. The patients receiving placebo would suffer from excruciating pain and withdrawals within 1-2 days maximum. Therefor any patient that received the placebo would immediately know they were receiving it and drop out of the study rendering it useless. This may suit the authors of this guideline as the studies that they site as evidence are similarly useless. All of this information is in the guideline itself if someone took the time to read the complete report, a responsibility that would fall directly on the shoulders of each Director.
The following is a link to the suicides resulting from tapering or abruptly stopping opioids based on the CDC Guideline compiled by a compassionate and caring physician named Dr. Kline. These do not represent all of the suicides do to the CDC and regulatory bodies such as yours but is a list the great doctor has composed in his spare time when not treating or advocating for the rights of chronic pain patients, followed by some excerpts. https://medium.com/@ThomasKlineMD/opioidcrisis-pain-related-suicides-associated-with-forced-tapers-c68c79ecf84d
Dr. Kolodny (the founder of PROPaganda) commented on the pain related suicides cases: “ There is good evidence the majority were suffering from opioid addiction”. He was not familiar with the cases.
Dr. Kolodny is not a specialist in pain medicine. He is a trained psychiatrists who benefits financially from every “addict” he assumes care for. He has also made over $500,000 as a self proclaimed expert for the prosecution in cases where well intentioned, caring and compassionate doctors were put on trial for their prescribing habits without regard to the conditions of their patients. He alone has been responsible for imprisoning doctors who faithfully executed their Hippocratic Oath. Dr. Kolodny also stands to make untold millions and possibly billions as an “expert” witness for the prosecution in the lawsuits against opioid manufacturers and suppliers.
Doctors across the country actually believe the CDC/PROP manifesto of pain medicines not working and too dangerous to use, a false assumption. Their belief that “addictions and overdoses” are being prevented by eliminating opiate pain medicine is a failure of science, reason, and common sense. These people are no longer with us due to the policy of “you are better off without pain medicines”
No case has been reported of true addiction suddenly occurring while taking pain medicine in the 10 million with long term pain disease, belying the governments’s belief that addictions will be prevented if the population as a whole does not take them.
Suicide prevention in the ten million noted by NIH requiring daily pain medicine is pain care. Not providing suicide prevention is negligence. Not treating a person in pain is negligence. Abandoning people with painful disease to the streets with no doctor, is negligence. Believing you can addict the general population is ignorance. Believing serious pain can relieved with Tylenol, meditation, expensive injection therapy, anticonvulsants, and physical therapy — is ignorant. The longer you wait to treat pain the more serious it becomes. Opiates remain the treatment of choice for serious pain, no matter what a few extremists purport.
This nihlist medical view is not accepted by most U.S. practicing physicians, nor in other countries, nor by the World Health Organization. The CDC and its PROP consultants have an extreme view, a pain nihilism manifesto, with unfounded near shrieking polemics, a bizarre “lunatic fringe” (FDA senior official) plan for the earth riding through every doctor office in the land with warnings not to addict or kill using “heroin pills” in the words of Thomas Frieden CDC director allowing the Guideline to be published by an Agency not tasked with opiate recommendations.
Allison Kimberly, age 30, of Colorado was denied treatment for her intractable pain from interstitial cystitis and several other painful conditions. Interstitial cystitis can end in suicide from the failure to treat it properly as it is an extreme form of agonizing discomfort. It is said that the University of Colorado emergency room in Aurora refused her treatment for her pain. deceased
Allison posted on Instagram describing how she was treated as an addict and sent away without pain medicine. “I was rushed to the ER because my pain was so out of control I couldn’t take it anymore, I got ZERO help. After 7 hours I was discharged. The nurse has the nerve to say that my kind of pain shouldn’t be that bad and basically I was faking for medication. I am so beside myself I am shaking as I type this. Screaming and begging in pain, needing any kind of help they’d give me and I was just sent home. As soon as I am able I’m reporting my whole experience.” Allison did not have time to file a complaint against the hospital as she violently ended her life while her mother walked her dog, the animal companion that had made her anguish less lonely. No doctors appear to have been charged. The Colorado Hospital Association was in the process of piloting a no-opioid policy for the state. She died in June, 2017.
How any human being can read these stories and fail to take appropriate measures to keep it from happening again is gruesome, scandalous, repugnant, outrageous, obscene and nefarious. No longer can you claim ignorance of the harm and dangers this is causing. Lack of action at this point would be gross negligence and dereliction of duty. The purpose of having an agency to regulate medical treatment is there to safeguard patients not to commit negligent manslaughter. Instead the focus has been driven not only to the treatment of addicts but to treat anyone suffering from chronic pain AS addicts.
The ADA prohibits government agencies that receive any federal funding from discriminating against Americans with Disabilities. Chronic pain is a leading cause of disability in the United States. Denying proper and adequate medical treatment that effectively reduces pain to those of us that are disabled by chronic pain is a clear violation of law. Hiding behind a guideline produced by an agency with NO authority to regulate prescription drugs in the United States is not a valid excuse. A strong case could be made for malicious intent.
With the swipe of a pen almost all of the harm that was caused can be reversed. This will not bring back Allison and the others that have died due to the overzealous application of an invalid guideline, but their deaths do not have to be in vein. If it were to effect change the circumstances for the rest of us I believe their families would be happy knowing their loss has helped millions of others. I don’t wish to make any threats as I believe that the appropriate agencies will do what’s right for those of us suffering in MO, however if a remedy can not be reached by communication I will be forced to gather all my struggling brothers and sisters together to file an ADA claim against Steve Corsi, Psy.D as the director of the Department of Social Services, Randall Williams, MD as the director of the Department of Health, and Mark Stringer, as the director of the Department of Mental Health.
In addition you will find attachments of the press releases by the CDC and FDA that discourage forced tapering and stress that the guidelines have been wildly misinterpreted. You will also find the FDA’s refusal to accept the recommendations of PROP that later formed this grotesque unlawful guideline.
From: “Boeger, Michael” <Michael.Boeger@health.mo.gov> > Date: November 12, 2019 at 8:33:12 AM CST > To: “‘ff5863@yahoo.com'” <ff5863@yahoo.com> > Subject: Your email about opioid milligrams and enforcement > > November 12, 2019 > > > > Dear Dr. Pezzani: > > > > As a result of the opioid abuse epidemic, the CDC issued and published an educational guideline relating to the prescribing of controlled drugs. > > > > Our department made it a specific point to let practitioners know that this was an educational guideline and that it was not a law that could be enforced. If doctors choose to prescribe more, this is not a direct violation of law or regulation. The guideline wanted to stress that doctors review their patient charts and look to see how much they are prescribing, then make their own decisions. > > > > During the past several years, our bureau has not revoked or suspended any doctors merely for prescribing too many opiates. > > > > Upon reviewing our records, the Board of Healing Arts and the Dental Board have not revoked or suspended anyone from over-prescribing. > > > > Doctors are allowed to review their own practices and make their own decisions. The CDC guidelines are not being enforced upon them > > as a law. > > > > Our current studies we have seen online show that about 30% of the overdoses are from prescription drugs and 70% are from “street drugs.” > > > > However, of the 70% addicted and abusing street drugs, the study showed that 80% of them started off with a prescription drug problem. > > > > At this point, that only action taken is that the CDC has asked the doctors to review and make their own decisions. > > > > > > Michael R. Boeger, Administrator > > Missouri Bureau of Narcotics and Dangerous Drugs > > P.O. Box 570 > > Jefferson City, MO 65102-0570 > > Phone: (573) 751-6321 Fax: (573) 526-2569 > > Website: www.health.mo.gov/BNDD
I suspect that this law, is a law is to preempt any consequences to the anticipated overturning of the Roe vs Wade concerning abortions. Just read the test of the bill that is RED below… What happens if a health insurance company or a major healthcare corporation that declares that ALL CONTROLLED SUBSTANCES ARE ADDICTING… and they are not going to pay, prescribe or fill any controlled medication- because it is UNETHICAL to possibly cause someone to become addicted to these medications that the DEA has declared – for some 50 yrs – that they are DANGEROUSLY ADDICTING. That is nothing short of a full blown bureaucratic creep.
New law lets South Carolina providers deny care that conflicts with personal beliefs
South Carolina Governor Henry McMaster signed the Medical Ethics and Diversity Act into law June 17, allowing healthcare institutions, medical practitioners and health insurers to deny non-emergent care that conflicts with their “religious, moral or ethical beliefs.”
“As the right of conscience is fundamental, no medical practitioner, healthcare institutions and healthcare payers should be compelled to participate in or pay for any medical procedure or prescribe or pay for any medication to which the practitioner or entity objects on the basis of conscience, whether such conscience is informed by religious, moral or ethical beliefs or principles,” the act states. “It is the purpose of this chapter to protect medical practitioners, healthcare institutions and healthcare payers from discrimination, punishment or retaliation as a result of any instance of conscientious medical objection.”
Coverage under the law is sweeping. “Healthcare institution” covers any public or private hospital, clinic, physician group, ambulatory surgical center, private physician office, pharmacy, nursing home, medical school, nursing school or any entity “in which healthcare services are performed on behalf of any person.” By “healthcare payer,” the law covers insurers, employers or any entity that pays for a patient’s healthcare in part or in full. By “medical practitioner,” the law covers anyone asked to participate in any healthcare service.
The act took effect upon the governor’s signing. South Carolina is the latest state to protect healthcare providers’ “right of conscience.” Arkansas enacted a similar proposal in March 2021.
South Carolina Senator Larry Grooms championed the Medical Ethics and Diversity Act. Supporters of the law include the Roman Catholic Diocese of Charleston; opponents include the American Academy of Pediatrics and the Human Rights Campaign.
