What would happen… IF… ?

Posted on December 2, 2018 by Pharmaciststeve

It  is claimed that there are 10 MILLION ESI given to pts every year in this country and that an estimated 5% of the ESI’s will cause Arachnoiditis       

That is described as a VERY PAINFUL and IRREVERSIBLE disease state/condition.

One of the medications that is typically uses is Depo-Medrol which is a suspension of Methylprednisone – but some physicians may be using other corticosteroids that are in the same class as Depo-Medrol.

Both the FDA and Pfizer – who manufacturers the medication – has come out and strongly recommended that this medication NOT BE USED in ESI’s. Many other countries have BANNED these medications being used in ESI’s.

Recently the FDA,  FDA Warns Against Off-Label Use of Implantable Pain Pumps

The only opiate that is approved for use in implanted pain pumps is INFUMORPH (Morphine) and often pain docs use a pharmacy compounded cocktail in the implanted pump in their pts.  BECAUSE.. it is claimed that the pain clinic can purchase the compounded product for 10%-25% of the cost of the commercial product.

The question has to be asked … why does Medicare/Medicaid and other health insurance companies pay for these product(s) and procedure(s).

What is even more questionable is that it was recently reported that Medicare was going to increase the allowable – what is paid physicians – on providing ESI’s.

I have also read statements from chronic pain pts that have indicated that their pain clinic refuse to prescribe oral opiates to pt who do not want to have ESI procedures, especially those pts who have had them in the past and they have received little/no benefit and/or benefit was very short lived, less than what would be expected. Some suggest that this may be in violation of a part of the Sherman Antitrust Act called Tying Commerce   which basically states that forcing someone to purchase something they don’t want/need in order to be able to purchase something that they want/need.

So do we have three federal agencies (FDA, DOJ, HHS) with policies in conflict.

What would happen if some pro-pain group(s) petitioned the FDA to  BAN or declare the use of these medications in these particular applications as EXPERIMENTAL. No insurance company will pay for experimental medications.

Has anyone noticed that when the DEA charges a prescriber with inappropriate (medically unnecessary) prescribing of opiates… that they are also charged with Medicare fraud ?

If the FDA won’t act, then Congress is always talking about getting rid of Medicare fraud and abuse.. maybe talking to members of Congress to get these specific medications no longer being reimbursed… may be an option.

What has the chronic pain community got to lose ?

 

 

Filed under: General Problems | 3 Comments »

Everyone knows that CHINA is one of the most honest/ethical countries on this planet ?

Posted on December 2, 2018 by Pharmaciststeve

China agrees to make fentanyl a controlled substance after talks with US at G20 summit

https://www.cnn.com/2018/12/01/politics/fentanyl-us-china-g20-talks/index.html

(CNN)China has agreed to reclassify fentanyl as a “controlled substance,” in what the White House is calling a “wonderful humanitarian gesture” after the much-anticipated talks Saturday between US President Donald Trump and Chinese President Xi Jinping in Buenos Aires, Argentina.

In a statement, China’s Foreign Ministry said China has “decided to schedule the entire category of fentanyl-type substances as controlled substances, and start the process of revising relevant laws and regulations.”
China and the United States have “agreed to take active measures to strengthen cooperation on law enforcement and narcotics control,” including the control of fentanyl-type substances, it said.
The new designation for the synthetic opioid drug means people in China who sell fentanyl to the US “will be subject to China’s maximum penalty under the law,” according to a statement from the White House.
Trump and Xi met Saturday for dinner on the sidelines of the G20 summit in Buenos Aires.
Fentanyl’s new designation is one result from their meeting. The US also agreed to maintain the 10% tariffs on $200 billion worth of Chinese goods, instead of raising them to 25%, the White House said.
Fentanyl, an extremely powerful drug, is 50 to 100 times more potent than morphine and 30 to 50 times more potent than heroin.
What you need to know about fentanyl

What you need to know about fentanyl
According to the US Centers for Disease Control and Prevention, 5,500 people died of synthetic opioid overdoses in 2014, most of them related to fentanyl. That’s an 80% increase over the number of deaths reported in 2013. Last year, the Drug Enforcement Administration issued a national alert stating that “drug incidents and overdoses related to fentanyl are occurring at an alarming rate.” In 2013, the Drug Enforcement Administration made 942 fentanyl seizures; in 2014, it made 3,344.
In August, Trump claimed on Twitter Chinese suppliers are fueling America’s opioid crisis.
“It is outrageous that Poisonous Synthetic Heroin Fentanyl comes pouring into the U.S. Postal System from China. We can, and must, END THIS NOW! The Senate should pass the STOP ACT — and firmly STOP this poison from killing our children and destroying our country. No more delay!” the tweet said.
Yu Haibin, a senior official with China’s National Narcotics Control Commission, said in a press briefing at the time that Trump’s comments were “unacceptable” and “irresponsible.”
“The United States has no proof that most fentanyl in the country comes from China,” he said. “It’s highly irresponsible to draw such a conclusion based on some individual cases.”
Officials in Washington believe China is the primary source of fentanyl found within US borders, following a 2017 US Congressional report citing law enforcement and drug investigators.
Trump last year declared the opioid crisis a public health emergency in the United States and brought up the issue with Xi when the two leaders met in Beijing in November 2017.

CNN’s Kevin Bohn and Steven Jiang contributed to this report.

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SCOTUS: to rule that civil asset forfeiture law – UNCONSTITUTIONAL ?

Posted on December 1, 2018 by Pharmaciststeve

Neil Gorsuch and Sonia Sotomayor Just Came Out Swinging Against Policing for Profit

https://slate.com/news-and-politics/2018/11/neil-gorsuch-sonia-sotomayor-tyson-timbs-civil-forfeiture.html

Tyson Timbs just wants his car back. In 2015, Timbs was charged with selling heroin to undercover officers in Indiana to fund his opioid addiction. After he pleaded guilty, a private law firm filed a lawsuit on behalf of the state to confiscate his Land Rover SUV, valued at $42,000. That’s more than four times the maximum $10,000 fine for Timbs’ crimes. But because he briefly carried drugs in the vehicle, the firm claimed that it could seize and sell it, turning over some of the profit to Indiana and pocketing the rest.

Welcome to the topsy-turvy world of civil asset forfeiture, also known as legalized theft. Every year, the federal and state governments obtain billions of dollars thanks to the work of prosecutors who expropriate property with some tenuous connection to a crime. Most states use the money to fund law enforcement, called policing for profit. Indiana also lets private attorneys file forfeiture claims against defendants, earning contingency fees and a share of the profit. That’s what happened to Timbs—so he sued, insisting that extreme forfeiture violates the Constitution. On Wednesday, the Supreme Court signaled that it agreed, with an unusual coalition of justices assailing the practice. A decision for Timbs could curb law enforcement abuses across the country, limiting one of the most scandalous components of our criminal justice system.

In a sense, Timbs v. Indiana is a pretty easy case. The Eighth Amendment bars the imposition of “excessive fines,” and the Supreme Court has already recognized that the forfeiture of personal property qualifies as a “fine” for constitutional purposes. It has also ruled that fines may not be “grossly disproportionate” to an offense. When the government seized Timbs’ car—which, again, is worth vastly more than the monetary penalty for his crime—it would seem to have imposed a grossly disproportionate fine in violation of the Eighth Amendment.

But, weirdly enough, the court has never explicitly held that this rule restricts state governments. The Bill of Rights originally applied only to the federal government, as the Framers were hesitant to limit state sovereignty. After the Civil War, Congress drafted the 14th Amendment with the intent to “incorporate” the Bill of Rights against state governments as well. Throughout the 20th century, the Supreme Court held that almost all these rights did, indeed, apply to states. That’s why neither Congress nor your state government may infringe upon your freedom of speech, authorize an unreasonable search, or compel self-incrimination. But the court has never had an opportunity to squarely state that the excessive fines clause is “incorporated”—until now.

There is little doubt that the justices will use Timbs to incorporate the clause at long last. Under long-standing precedent, a right that is “fundamental” to “ordered liberty” and “deeply rooted” in history receives protection under the 14th Amendment. And in its extraordinary brief, the Institute for Justice—the libertarian firm representing Timbs—demonstrates that the right against excessive fines checks both boxes. It was enshrined in the Magna Carta and safeguarded by most state constitutions when the U.S. Constitution was ratified. When Congress wrote the 14th Amendment, lawmakers argued that it would nullify “Black Codes” in Southern states that levied crippling, arbitrary fines on newly freed slaves. There is really no plausible argument that the right against excessive fines is not “fundamental” or “deeply rooted” and thus incorporated against the states.

So when Indiana Solicitor General Thomas Fisher approached the lectern to argue that the excessive fines clause doesn’t fully apply to Indiana, Justice Neil Gorsuch pounced. “Can we just get one thing off the table?” he asked. “We all agree that the excessive fines clause is incorporated against the states. … Can we at least agree on that?” Fisher hedged, but Gorsuch shot back: “I think a ‘yes’ or ‘no’ would probably be a good starting place.” Fisher tried to suggest the truth was more complicated, but Gorsuch cut him off, noting that most of the Bill of Rights was incorporated “in, like, the 1940s.”

“And here we are in 2018, still litigating incorporation of the Bill of Rights,” the justice said. “Really? Come on, General.” He leaned back in his chair, grinning like the cat that caught the canary.

Although Gorsuch led the charge, no justice seemed to think that the Constitution permits states to impose excessive fines. So Fisher raised a backup argument, alleging that the Eighth Amendment doesn’t bar forfeitures of property, only money. The problem with this claim is that the court rejected it in 1993’s Austin v. United States. So Fisher asked the court to overrule Austin, further flummoxing Gorsuch.

“Let’s say this court’s not inclined to revisit Austin,” he told Thomas. “You’re going to lose not just the incorporation question but the merits question too.” Justice Stephen Breyer asked if Indiana could seize a Bugatti if it was going 5 miles per hour over the speed limit. “Yes, it’s forfeitable,” Fisher responded. Breyer mused: What about a “Mercedes, or a special Ferrari or even jalopy?” Fisher laughed at Breyer’s fanciful hypotheticals. But Justice Sonia Sotomayor, Gorsuch’s new criminal justice ally, looked unamused.

“Justice Scalia said it very well,” she told Fisher, quoting Scalia’s opinion in Austin. “For the Eighth Amendment to limit cash fines while permitting limitless [property confiscation] would make little sense.” Instead, it would revive England’s notoriously lawless Star Chamber. Gorsuch nodded vigorously in agreement. “Are we trying to avoid a society that’s like the Star Chamber?” Sotomayor asked. “If we look at these forfeitures that are occurring today … many of them seem grossly disproportionate to the crimes being charged.”

She’s right. In Philadelphia, prosecutors seized one couple’s house because their son was arrested with $40 worth of drugs. Officials there seized 1,000 other houses and 3,300 vehicles before a 2018 settlement that led to reparations for victims. In 2014, federal prosecutors used asset forfeiture to take more stuff than burglars. One Texas police department seized property from out-of-town drivers, then colluded with the district attorney to coerce these drivers into waiving their rights. Law enforcement frequently targets poor people and racial minorities, figuring they are unable to fight back.

Although he said nothing on Wednesday (as usual), Justice Clarence Thomas is one of the court’s fiercest critics of civil asset forfeiture. In 2017, he wrote a solo opinion urging the court to rein in the practice. Citing its “egregious and well-chronicled abuses,” Thomas asserted that the Constitution likely does not allow police to “seize property with limited judicial oversight and retain it for their own use.” And in 1998, he authored a 5–4 decision, joined only by the liberals, outlawing forfeitures that are “grossly disproportional to the gravity of [the] offense.”

So while Gorsuch and Sotomayor led the fight on Wednesday, there’s probably a cross-ideological coalition of justices prepared to invalidate excessive forfeitures. Such a ruling would reflect broad agreement across the ideological spectrum that forfeiture has gone too far. Among the organizations that wrote or joined amicus briefs supporting Timbs are the progressive ACLU and NAACP; the libertarian Cato and Goldwater institutes, as well as the Pacific Legal Foundation; the conservative Chamber of Commerce and Judicial Watch; and the fundamentalist Foundation for Moral Law, which is “dedicated to the defense of God-given liberties.”

Only Chief Justice John Roberts and Justice Samuel Alito expressed any interest in allowing civil asset forfeiture to continue unabated. A majority of the court seems poised to rule that all 50 states must stop seizing property in a way that’s grossly disproportionate to the crime committed—a holy grail of criminal justice reformers. In one fell swoop, defendants will receive new protections against the legalized theft of their stuff. And Tyson Timbs, who attended Wednesday’s argument, can demand that Indiana return the Land Rover that it never had a right to seize in the first place.

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AARP: cares about out of pocket med costs… but … compare their medicare supplement premiums

Posted on December 1, 2018 by Pharmaciststeve

When I was first eligible for Medicare and went to purchase a Medicare supplement… I knew that Congress had defined abt 8-10 different supplement programs as to what they cover…  they are defined something like A thru N…  and no insurance company can offer any Medicare supplement other than what Congress has defined and a insurance company doesn’t have to offer every plan that Congress has defined.

AARP endorses United Health, a for profit publicly held company.  Many people don’t realize that there is two different profit structures for insurance companies

“mutual companies” are typically not-for-profit , which means that the policy holders “own the company” and those that are publicly held FOR PROFIT companies and who has shares of stock listed on the stock market. Like some 8000-9000 for profit companies that are listed on the various stock exchanges.

When I first started looking for a Medicare supplement for myself back in 2012… I found that a mutual insurance company and that endorsed by AARP… a FOR PROFIT company… in comparing the same “plan letter”. Found that AARP’s endorsed plan was $20 MORE PER MONTH

I also found that the mutual company offered a plan that the only difference of the previous plan was that I had to pay the annual Part B deductible – some $140 each year but the premium dropped another $20/month.  The math of paying $240 less/yr and having to pay out $140 deductible out of pocket – only if I had to use some medical services during the year.  So I was able to save abt $680/yr – for the two of us – becoming a policy holder of the mutual insurance company.

I guess the first $20 difference between the mutual company the AARP endorsed program…  AARP does not “give” their endorsement away.. they get some $$$ for a company being able to promote the fact that they are endorsed by AARP.

So it would appear that AARP is concerned about Seniors and what they have to pay out of pocket for medical care… doesn’t seem to apply when a higher price… puts some money back in AARP’s coffer ?

For those chronic painers that read this blog… if you go to https://www.aarp.org/ and do a search for “chronic pain” you will get back some 400 different articles and the few that I scanned … have a definite anti-opiate lean and promoting a lot of non-opiate therapies that by and large are not paid for by health insurance. So they don’t seem to have much of a concern of what people pay out of pocket – especially if their endorsed Medicare part D insurance company doesn’t have to pay for opiates.

They even have a article – that most chronic painers understand is not really truthful  Opioids Don’t Ease Chronic Pain More Than Other Drugs

A study that “proved” that non-opiates will work as well as opiates

 

Filed under: General Problems | 3 Comments »

Medical accident deaths 250K- 400K/yr … is this part of the reason ?

Posted on November 30, 2018 by Pharmaciststeve

Bad Docs Give Up Licenses, But Not Medical Practice

https://www.medpagetoday.com/special-reports/states-of-disgrace/76584

More than 250 surrender licenses in one state, but still practice in another

In Louisiana, Larry Mitchell Isaacs, MD, gave up his medical license in the face of discipline, after he removed an allegedly healthy kidney during what was supposed to be colon surgery.

In California, he mistakenly removed a woman’s fallopian tube. According to medical board records, he thought it was her appendix — which already was gone. More surgeries on the woman followed, including one in which he allegedly left her intestine unconnected.

Facing state sanctions, he surrendered his license there, too.

In New York, where regulators were moving to take action based on his California problems, he also agreed to give up his license.

But in Ohio, he has found a home.

There, his medical license remains unblemished, allowing Isaacs to work at an urgent care clinic in the Cincinnati area.

Larry M. Isaacs, MD, talks to his wife during an open house welcoming him to Morehouse General Hospital in Basrop, Louisiana in 2012. (Photo: Vicki Adams/Bastrop Daily Enterprise)

Surrendering a license is often done in the face of overwhelming evidence of unprofessional conduct. It can come after repeated surgical mishaps, churning out improper opioid prescriptions, or years of having sex with patients.

A license surrender can spare a physician the time, expense, and reputational harm that might come with formal charges and a hearing before a state medical board. Typically, it comes with no restriction on practicing elsewhere.

States can take action against physicians based on license surrenders in other places. But, as with other matters in the broken world of physician discipline, such a step is spotty. Some states don’t even search a national database of troubled physicians.

What’s more, voluntary license surrenders can mean the public gets no access to information about what happened, putting future patients at risk.

More than 250 physicians who surrendered a medical license were able to practice in another state, an investigation by the Milwaukee Journal Sentinel, USA Today and MedPage Today found.

“It is very concerning to think a physician surrenders in one state and doesn’t surrender in another,” said John Harris, MD, an assistant professor of medicine at the University of Pittsburgh Medical Center, who has researched how physician discipline varies from state to state.

“There seems to be an inconsistency and danger. As a physician, I want our patients to be safe and I want these people not practicing.”

In a third of the 250 cases, physicians who surrendered their licenses were able to practice elsewhere without any limitations or public disclosure, simply by changing their addresses.

In the other cases, they faced disciplinary action that patients might not be able find out about.

The analysis was done using data provided by TruthMd, a private firm that compiles information on physicians from thousands of sources, such as state medical boards and local courts. Its information typically is used by hospitals and insurance companies. The analysis was limited to physicians who had action by a state board recorded since 2013. The real number of doctors who have surrendered their licenses, yet continue to practice is certainly higher.

Earlier, the Journal Sentinel and MedPage Today used data from the firm to identify more than 500 physicians who had been disciplined in one state yet still were able to practice elsewhere with a clean license.

The news organizations also found 73 cases where the FDA sent warning letters to physicians alleging serious patient safety concerns, though only one had been disciplined by a state board.

The investigation found 216 physicians who collected a total of $26 million from federal taxpayers through Medicare despite losing a license or being excluded from state-paid health care rolls.

In theory, a surrendered license in one state should tip a second state to the fact that there are problems. Instead, for many doctors it amounts to a get-out-of-jail-free card.

In an interview, Isaacs said he gave up his licenses in California, Louisiana, and New York to avoid costly legal fights. In defending his actions, he provided letters from other physicians who said he had acted appropriately.

“I didn’t do anything wrong anywhere,” he said.

Isaacs’ trail of alleged misdeeds was unusually severe among the cases examined.

But, in case after case, a license surrender in the face of discipline for bad behavior in one state was met with far more lenient discipline — if any punishment at all — in another.

Consider:

  • Heart surgeon Sean Yetman, MD, performed just seven surgeries at Meriter Hospital in Madison, Wis. Two of those patients died. Malpractice lawsuits were filed in both cases. Yetman surrendered his Wisconsin license in 2014. He was able to continue practicing in New York, where he already had a license.
  • In February 2015, cardiologist John Strobeck, MD, was charged by the Passaic County, N.J., prosecutor’s office with criminal sexual contact, according to the state medical board. He allegedly had inappropriate sexual contact with six female patients in an exam room “under the guise of providing medical treatment.” Six months later, Strobeck agreed to surrender his New Jersey license. California took action based on the case, and he surrendered his license there. In New York, he has no restrictions. The original charges are still pending.
  • In 2017, neurologist Gautam Sehgal pleaded guilty in New Jersey to criminal charges of paying kickbacks to other medical professionals for referrals and submitting insurance claims for procedures that were never done. Sehgal agreed to surrender his New Jersey license, and he is no longer eligible for Medicaid money in either New Jersey or New York. He remains licensed and in good standing in California.
  • John Kidd, MD, a Wisconsin anesthesiologist, gave up his license rather than fight multiple allegations of negligence. He relocated to upstate New York where he currently practices. Click here for a detailed look at his case.

“All of those cases are troubling,” said Michael Carome, MD, who heads the consumer advocacy group Public Citizen’s healthcare division, which has studied state-to-state variation in physician discipline. “Actions should have been taken against them in the states where they remained licensed.”

Secretive system hides problems

In some states, surrenders are particularly secretive — leaving patients in the dark about what happened.

Records show that psychiatrist Robert Sack, MD, permanently surrendered his Maryland license in 2012 rather than face discipline — but his public file does not spell out what he did. It only references a line in state law relating to “unprofessional conduct in the practice of medicine.”

Based on Maryland’s action, neighboring Virginia quickly suspended him from practicing there.

In a 2012 letter to the Maryland medical board, Sack noted his license surrender was related, in part, to his “planned retirement from the practice of medicine.”

Shortly thereafter, he opened a legal battle to be allowed to practice in Pennsylvania, where his license had just expired.

The Pennsylvania board eventually issued a reprimand, but it allowed Sack, who specializes in child and adolescent psychiatry, to practice.

In fact, by surrendering his Maryland license, the board said, he demonstrated “the good moral character and judgment the board expects from its licensees.”

To try to determine what prompted the case, reporters filed a series of open records requests.

Maryland, where the matter began, refused to release any documents. Pennsylvania released several hundred pages of materials that showed the surrender stemmed from him having a romantic relationship with a former patient in Maryland.

The American Psychiatric Association views sexual contact with patients, including former ones, as unethical — a standard many states follow in licensing.

The Pennsylvania records show that Sack’s attorneys told officials that he had no plans to actually practice there. But, an Internet search found Sack listed as a practicing child and adolescent psychiatrist at T.W. Ponsessa & Associates, a Lancaster, Pa.-based counseling service.

CEO Cathy DeGuire told a reporter she was not aware of Sack’s disciplinary background when he was hired. Before hanging up, she said that the listing online was an error — stressing Sack only works with patients 16 and older.

Three days latter the website was changed to say he sees patients aged 16 to 64.

Sack did not respond to efforts to reach him through the attorney or his employer. His attorney declined to comment.

State hopping begins in California

For Larry Isaacs, records show that problems began in California. (Click here for a full timeline.)

On May 4, 2009, a woman identified in records only as “G.G.” was admitted to the Henry Mayo Newhall Memorial Hospital in Valencia with abdominal pain.

Isaacs suspected she had appendicitis. However, a medical board document, known as an accusation, says he failed to perform the proper diagnostic tests.

Indeed, G.G. didn’t even have an appendix.

Thinking he was removing her appendix, Isaacs instead took out a fallopian tube, according to the documents. Four days later, the hospital discharged her.

On Feb. 6, 2010, she returned to the hospital, again complaining of abdominal pain. A CT scan indicated she had a hernia in her abdomen. Another CT scan indicated a second hernia in her pelvis.

Henry Mayo Newhall Hospital in Valencia, Calif. (Photo: Google Maps)

A hernia is when an organ pushes through the muscle or tissue that holds in it place. In hernia repair, physicians often use mesh instead of stitches alone to strengthen the area being repaired and to help prevent a recurrence.

In this case, Isaacs used the wrong size mesh.

The mesh Isaacs used was ½ inch wide, “whereas the standard of care requires that the mesh overlap the hernia by 3 centimeters (1.2 inches) on each side,” the documents said. What’s more, he used a synthetic, non-absorbable mesh, which increased the risk of infection.

An alternative would have been to use just stitches or a type of biological mesh that eventually dissolves into the body.

Six days later, X-rays showed a hernia in the same area. The documents say either there was a different, undiagnosed hernia, or Isaacs’ previous surgery was inadequate.

A few days later, yet another CT scan showed a large hernia that involved the small intestine. Isaacs performed another surgery, removing part of G.G.’s small intestine. That same day, he operated on her again.

Over the next few days, CT scans showed that Isaacs had left a portion of her intestine unconnected, creating an environment that allowed infection to occur, documents say.

Finally, on March 2, G.G.’s care was transferred to another surgeon. Isaacs was relegated to an assistant role, explaining to the new surgeon what he had done.

California records do not indicate what happened to G.G.

In an interview, Isaacs said she is doing well. He acknowledged she later sued him and received a $310,000 settlement. He said he told the insurance company to settle the case.

Reporters could not locate the settlement in California court documents.

In December 2014, G.G.’s case wound up in front of the California medical board, when Isaacs was accused of gross negligence, repeated negligent acts, and incompetence in her care.

Isaacs only admitted to inadequate record keeping. He agreed to surrender his California license in 2016.

A serious matter

There are tools to help medical boards stay up to date on the actions of the physicians they license. The National Practitioner Data Bank was started by Congress in 1986 as a central repository for malpractice payments, state disciplinary actions, restrictions from health plans or hospitals, and other limits set for a healthcare professional.

The database now has more than 1.3 million records of “adverse actions” going back to 1990.

It’s open to hospitals, insurers, and state medical boards, but it is not available to the public. What’s more, medical boards often don’t even use it. Last year, 30 medical boards performed fewer than 100 searches; 13 didn’t perform any at all.

Some defenders of the system note that physicians make mistakes, and there are cases when a license surrender shouldn’t automatically keep them from practicing medicine.

For example, many states have programs to help physicians deal with substance abuse issues.

Attorney Eli Stutsman of Portland, Ore., specializes in representing physicians and other medical professionals. He said he had represented at least two people who got the help they needed and are now back at work, without any new problems.

“Do they have some history? Yes. Did they make some compromises to return to work? Yes. Are they reinstated? Yes, and I wouldn’t be afraid to see either of them,” he said.

“Good practitioners have been caught up in this. I’d be careful to not paint with such broad strokes.”

Stutsman started practicing law in the early 1990s. At the time, he said, physicians could take advantage of the gaps in information between states. Some states were notoriously slow when it came to staying up-to-date on physicians’ transgressions.

Given all the information available today, he was surprised that a case like Isaacs’ — involving multiple surrenders and actions in multiple states — could exist.

He noted that physicians routinely have to report disciplinary actions, revocations and surrenders to various regulatory bodies. Omitting such a report, can be cause for serious disciplinary action on its own. Indeed, some medical license surrenders analyzed by the news organizations came as a result of failing to report the discipline in another state.

A second chance; then a third

In January 2012 — as Isaacs faced potential discipline in California — he moved to Bastrop, a city of about 11,000 in northeast Louisiana.

His first day at work was Jan. 12, six days after he was issued a license in the state.

According to an article in the Bastrop Daily Enterprise newspaper, Isaacs went to work at Morehouse General Hospital as a surgeon. Among other things, his specialties would include hernia repair and appendectomies, the story noted.

Shortly thereafter, Isaacs informed the Louisiana board that a hospital in the state had suspended his privileges. Publicly available documents don’t name the hospital or say where it was located. The board started its own investigation.

Morehouse General Hospital in Bastrop, Louisiana. (Photo: Google Maps)

The Louisiana board eventually accused Isaacs of failing to recognize that he had removed a healthy kidney from a patient during colon surgery.

Isaacs denied the allegation, saying that the removal of the kidney was warranted. But, in the fall of 2013, he agreed to surrender his Louisiana license.

He told the board that he had moved to New York, where he also had a license, and had no plans to continue practicing in Louisiana.

In New York, Isaacs worked in 2013 and 2014 as assistant director of trauma services at a hospital in Middletown, about an hour and half north of Manhattan, according to his résumé.

While in New York, the state Office of Professional Medical Conduct twice investigated allegations against Isaacs. It closed those cases without action, according to letters sent to Isaacs by the board.

However, the New York board cited his 2016 California license surrender as evidence of professional misconduct.

This led Isaacs to agree to permanently give up his license in New York in 2017.

He went to Ohio.

A confederation of boards

There is a flip side to this scenario: In some cases, the state where a physician runs into problems will allow the physician to keep practicing, but the same information results in a license surrender elsewhere.

Consider obstetrician Christopher Shay Driskill, MD, who in 2015, agreed to permanently surrender his California license based on what happened in New Mexico.

According to New Mexico board records, Driskill allegedly:

  • Had sexual relationships with several patients, including one to whom he improperly prescribed a tranquilizer
  • Wrote inappropriate personal notations on charts
  • Was not in attendance on multiple occasions when his patients gave birth, though he had been called by nurses and admitted the patients into the hospital

Once, the records say, he missed a delivery because he was having sex with another patient.

He also was found to be under the influence at work, where he kept a personal cache of alcohol.

Driskill denies the allegations. He said he surrendered his California license because he did not think he’d be able to keep it while practicing in New Mexico.

“I had no interest in working in California,” he said. “I didn’t need my California license anymore.”

New Mexico still allows Driskill to practice, though he must be chaperoned and can’t contact any patients with whom he had sex with.

He said he agreed to work under various stipulations in New Mexico, calling them “things I do to make sure everyone is comfortable and happy.”

Among the other physicians who fit this pattern:

  • In 2012, Abdus Lakhani, MD, an internist in Indiana, pleaded guilty to battery of a nurse, and was given a suspended sentence of 12 months in jail. The Indiana medical board put his license on probation, allowing him to keep practicing. In response to Indiana’s action, the California medical board sent Lakhani a letter saying that it planned to hold a hearing about the incident that could result in the revocation of his license. Instead of facing a hearing, Lakhani surrendered his California license.
  • Pain clinic physician Basim Elhabashy, MD, allegedly prescribed excessive amounts of opioids to patients in Florida without justification, according to a 2012 complaint issued by the Florida Department of Health. A report from the U.S. Drug Enforcement Administration listed him as the 48th largest purchaser of oxycodone in the U.S. in 2010. That amounts to 283,000 units of the drug, or 776 per day. Elhabashy was allowed to keep his Florida license with a reprimand and probation. But, he surrendered his New York and California licenses due to Florida’s complaint.

Last stop

Larry Isaacs now works at Tri-State Urgent Care in Cincinnati.

Tessie Pollock, a spokeswoman for the Ohio medical board, would not say why the board has not taken action against him.

“Even if the State Medical Board of Ohio had opened a complaint against Larry Isaacs to learn more about the allegations in California and Louisiana, I would not be able to disclose that or the findings,” she said in an email.

image

Larry Isaac’s Doctor of Medicine degree awarded by The Albany Medical College. (Photo: The Albany Medical College)

She said that the board takes allegations of “compromised patient safety and actions by other states very seriously.”

In an interview and emails, Isaacs offered a detailed defense of his conduct in the three states where he no longer is allowed to practice.

“I always went by the textbook,” he said. “Sadly, some doctors don’t know what is in it.”

He said a big reason he gave up his licenses in California, Louisiana, and New York was the cost of defending against the allegations, including paying attorneys who charged hundreds of dollars an hour. He also claimed that the system was rigged against him.

He said he did not leave G.G.’s intestine unconnected, as the medical board alleged. He said sutures broke down, which allowed the California patient’s intestine to leak.

As for the medical board, he said it goes after physicians to get revenue from fines — though a spokesman for the state’s medical board said it took only 450 actions last year, while the state has 113,000 licensed physicians.

The settlement of G.G.’s lawsuit?

He said it was because it would be hard to win a lawsuit, since many of the jurors would have been Hispanic and identified with the patient.

In the Louisiana case, Isaacs denied the allegations made by the board and said he had simply improperly dictated the surgery into the medical record. Had he dictated it properly, he said, it would have described a procedure and condition for which removing the kidney was warranted.

Records show an outside consultant hired by the board who found his care of the patient substandard. An independent peer review done for the hospital reached the same conclusion.

The surrender agreement itself includes this summary: “There was no evidence in the medical record that Dr. Isaacs recognized that he had removed a healthy kidney during the operative procedure or in the immediate postoperative period.”

Isaacs also said the case resulted from a contract dispute with the hospital that hired him. What’s more, he said, the hospital’s attorney was the nephew of the medical board president.

Actually, the two are father and son, said the attorney, Bill Bourgeois, who said it was sad Isaacs was raising that as an issue.

“Hospitals really don’t relish terminating a physician’s privileges,” he said in an email. “It costs money to retain an external peer reviewer, a hearing officer, and an attorney. In my opinion, terminating privileges is probably the last thing that a rural hospital would like to do with its limited financial resources.”

Aside from the kidney case that went to the medical board, there was a second problematic one.

The family of Lynn Hill, a 63-year-old Louisiana woman who Isaacs operated on in 2012, filed a lawsuit that alleged several negligent acts, including removing a non-cancerous kidney during a surgery to remove a tumor that was attached to the kidney.

Hill endured a variety of complications and other surgeries and died a year later.

Isaacs noted that a $133,000 settlement in the case was paid by a malpractice insurance trust fund, not him. He said he acted appropriately and that the kidney needed to be removed.

Isaacs said Ohio is the only state to fully investigate all of the cases, and it concluded that he should be allowed to practice.

Still, he said, he no longer is doing surgeries.

“This was my last stop,” he said. “I’m going to be 64 years old. I am just working as a physician and trying to live out my last years in peace.”

John Fauber is a reporter for the Milwaukee Journal Sentinel. Matt Wynn is a reporter for USA TODAY. Stacey Barchenger of the USA TODAY NETWORK-New Jersey contributed to this report.

This story was reported as a joint project of the Journal Sentinel and MedPage Today.

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US Attorney Andrew E. Lelling: warning letters “made no determination that the prescribers receiving these letters have violated the law.”

Posted on November 30, 2018 by Pharmaciststeve

US attorney issues warning to physicians over opioid prescriptions

https://www.bostonglobe.com/metro/2018/11/29/attorney-issues-warning-physicians-who-had-prescribed-opioids-patients-who-have-died/Y8Q8eylIfLZkHuv3MfpIsN/story.html

US Attorney Andrew E. Lelling has sent letters to “a number of medical professionals” alerting them that their opioid prescribing practices “have been identified as a source of concern.”

In a statement released Thursday, Lelling said that the professionals who received the warning had prescribed opioids to a patient within 60 days of that patient’s death or to a patient who subsequently died from an opioid overdose.

The letters inform the professionals that it’s illegal to prescribe opioids “without a legitimate medical purpose, substantially in excess of the needs of the patient, or outside the usual course of professional practice,” according to the news release from Lelling’s office.

He declined to provide the Globe with a copy of the letter and also would not say how many letters went out.

“We’re going to be doing this on an ongoing, regular basis,” said Christina DiIorio-Sterling, Lelling’s spokeswoman.

Lelling’s press release states that his office has “made no determination that the prescribers receiving these letters have violated the law.” Instead, the hope is to encourage professionals “to take stock of their prescribing practices and make any necessary adjustments.”

“The letter was meant to alert them that they’re on our radar,” DiIorio-Sterling said. “It’s a serious warning.”

But Leo Beletsky, an associate professor of law and health sciences at the Northeastern University School of Law, called the move “a blunt tool that sends waves of terror through the prescriber community. It shifts prescriber behavior in ways that hurt patient care.”

As a result, he said, doctors are often afraid to prescribe pain medications to patients who need them.

“It’s a solution in search of a problem because the crisis no longer even involves prescription drugs primarily. It’s driven by fentanyl,” Beletsky said.

State data show that prescription opioids are found in the bodies of only 17 percent of overdose victims while 90 percent had taken the powerful synthetic fentanyl, a street drug. (Many drug users take more than one substance simultaneously.)

Dr. Alain A. Chaoui, president of the Massachusetts Medical Society, noted in a statement that opioid prescriptions have already declined 35 percent over the past 3½ years, and there was “an even higher reduction in first-time opioid prescriptions.”

“We stand behind physicians providing evidence-based care to the sickest, most vulnerable patients,” Chaoui said. “We remain dedicated to promoting best opioid prescribing practices, and we urge all concerned parties to join us in expanding addiction treatment and fentanyl-driven overdose prevention.”

Asked about these comments, Lelling said in an e-mail that the decline in prescribing is no reason to pull back.

“In the midst of a national crisis killing thousands a year, we must take steps to stem the flow of opioids,” he said. “No doctor properly prescribing should have cause for concern.”

In February, then-Attorney General Jeff Sessions formed a Prescription Interdiction and Litigation Task Force to “deploy and coordinate all available criminal and civil law enforcement tools to reverse the tide of opioid overdoses,” including pursuing doctors and pharmacists who break the law in prescribing opioids.

The US attorney in Atlanta sent a similar letter to 30 doctors in northern Georgia last October. DiIorio-Sterling said that other districts have taken similar actions without publicizing it.

In an experiment published in August, doctors in San Diego County cut back on opioid prescribing by about 7 percent after receiving notices from the medical examiner that their patient had died of an overdose.

A 2015 study in Massachusetts found that more than 90 percent of people who survived an overdose on prescription opioids were able to obtain another prescription for opioids soon afterward. The researchers speculated that the doctors did not know their patients had overdosed.

“The opioid crisis is killing tens of thousands of people a year, including thousands in Massachusetts,” Lelling said in a statement. “One source of opioids — used for both legitimate and illegitimate purposes — is medical professionals, who have an obligation always to act in patients’ best interests.”

Felice J. Freyer can be reached at felice.freyer@globe.com. Follow her on Twitter @felicejfreyer.

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WA State: Changes to Opioid Prescribing and Monitoring

Posted on November 29, 2018 by Pharmaciststeve

Filed under: General Problems | 1 Comment »

large-scale humanitarian issue: forced opioid tapering in patients receiving long-term prescription opioid therapy for chronic pain

Posted on November 29, 2018 by Pharmaciststeve

International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering

https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pny228/5218985

Beth D Darnall, PhD David Juurlink, MD, PhD, FRCPC, FAACT, FACMT Robert D Kerns, PhD Sean Mackey, MD, PhD Brent Van Dorsten, PhD Keith Humphreys, PhD Julio A Gonzalez-Sotomayor, MD Andrea Furlan, MD, PhD Adam J Gordon, MD, MPH, FACP, DFASAM, CMRO Debra B Gordon, RN, DNP, FAAN … Show more
Pain Medicine, pny228, https://doi.org/10.1093/pm/pny228

We, the undersigned, stand as a unified community of stakeholders and key opinion leaders deeply concerned about forced opioid tapering in patients receiving long-term prescription opioid therapy for chronic pain. This is a large-scale humanitarian issue. Our specific concerns involve:

  • rapid, forced opioid tapering among outpatients;
  • mandated opioid tapers that require aggressive opioid dose reductions over a defined period, even when that period is an extended one.

Opioid tapering guidelines were created, in part, to decrease harm to patients resulting from high-dose opioid therapy for chronic pain. However, countless “legacy patients” with chronic pain who were progressively escalated to high opioid doses, often over many years, now face additional and very serious risks resulting from rapid tapering or related policies that mandate extreme dose reductions that are aggressive and unrealistic.

Rapid forced tapering can destabilize these patients, precipitating severe opioid withdrawal accompanied by worsening pain and profound loss of function. To escape the resultant suffering, some patients may seek relief from illicit (and inherently more dangerous) sources of opioids, whereas others may become acutely suicidal. Regardless of one’s view on the advisability of high-dose opioid therapy, every thoughtful clinician recognizes rapid tapering as a genuine threat to a large number of patients who are often medically complex and vulnerable. Indeed, even slower tapers should include realistic, patient-centered goals that are achievable and account for individual patient factors.

New and grave risks now exist because of forced opioid tapering: an alarming increase in reports of patient suffering and suicides within and outside of the Veterans Affairs Healthcare System in the United States.

Reports suggest that forced tapering is also occurring in patients on opioid doses below the Centers for Disease Control and Prevention Opioid Guideline threshold of 90 morphine equivalent daily dose. These patients too are at risk of harm from overly aggressive tapering.

Patients on legacy opioid prescriptions require different considerations and careful attention to the methods by which opioid tapers might be considered and implemented. Currently, no data exist to support forced, community-based opioid tapering to drastically low levels without exposing patients to potentially life-threatening harms. Existing data that support rapid reductions of opioid doses—often to zero—were conducted in highly structured, supportive, interdisciplinary, inpatient settings or “detox” programs in which medications and other approaches were used to minimize the symptoms of withdrawal. These data do not inform community-based opioid tapering. Currently, nonconsensual tapering policies are being enacted throughout the country without careful systems that attend to patient safety. The methods by which a taper is conducted matter greatly.

We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care—including prescribing, pharmacy, and insurance policies—and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

Almost 18 million Americans are currently taking long-term prescription opioids. We ask the Department of Health and Human Services to consider the following to mitigate harms in this special, at-risk population:

  • Enact policies that prohibit or minimize rapid, forced opioid tapering in outpatients taking legacy opioid prescriptions (this includes prescribers and health care organizations, pharmacies, and insurance payors).
  • Provide compassionate systems for opioid tapering, if indicated; that includes careful selection, patient-centered methods, close monitoring, triaging of adverse events, and realistic end-dose goals that are evidence-based and derived from applicable outpatient tapering data.
  • Convene patient advisory boards at all levels of decision-making to ensure that patient-centered systems are developed and patient rights are protected within the context of pain care.
  • Require inclusion of pain management specialists at every level of decision-making about future opioid policies and guidelines.

In standing as a unified community of concerned scientists, experts, citizens, and leaders of pain organizations in our respective countries, we call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.

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Is getting Prescriptions – IN THE MAIL – SAFE ?

Posted on November 29, 2018 by Pharmaciststeve

Virginia moves to limit mail-order specialty pharmacies following concerns of mishandling medicines for complex conditions

https://www.richmond.com/virginia-moves-to-limit-mail-order-pharmacies-following-concerns-of/article_43d79bec-a732-5434-ac0c-bec7e420e246.html

Shortly after Loretta Boesing’s son took medication delivered to the family’s home in Missouri on a hot summer day in 2012, he ended up in the hospital as the liver transplant he’d received at the age of 2 began to fail him.

Although the liver didn’t fail, he spent five weeks in the hospital. Boesing is convinced that the medicine, delivered to her door in a plastic bag, had been weakened by the heat in which it was transported, she said in an online petition she posted to Change.org that has gathered nearly 78,000 signatures from people in favor of tougher rules on mail-order specialty pharmacies and the insurance companies that require them.

These pharmacies, which focus on high-cost medication therapies to treat serious, complex conditions, such as cancer or rare diseases, are growing in popularity as insurance companies favor the cost savings that result from negotiations and personalization of the prescription to the patient.

As more people use the service, Virginia regulators are seeking greater control over the delivery of these medications from specialty pharmacies, either to a practitioner’s office — known as “white bagging” — or directly to the patient’s home — known as “brown bagging.”

The state’s Board of Pharmacy gave initial approval Wednesday to several rule changes aimed at reducing the chance of medication being mishandled due to delivery mishaps, including requiring delivering pharmacies to inform hospitals and doctors’ offices of expected arrival time and storage instructions for medicines, banning the delivery of drugs requiring special storage directly to the patient’s home, and mandating that the specialty pharmacy provide a return procedure for medications that are not delivered or administered.

Despite the associated risks, the prescription delivery model has gained traction in the U.S., at least in part due to reduced costs to insurance companies, which can negotiate prices with the pharmacies and are not generally subject to pharmacy regulations, according to a study published in April by the National Association of Boards of Pharmacy.

“Brown bagging” and “white bagging” can also save prescribers costs associated with purchasing and stocking medications and can spare them the process of billing for reimbursements, the study states.

Despite the benefits associated with the model, the NABP, as well as several health care providers who submitted public comment to the Virginia Board of Pharmacy, expressed concern about the potential for danger to patients, waste of expensive medications and unclear responsibility when something goes wrong with a delivery.

The Board of Pharmacy received five written responses during the public comment period following a public notice of intent to change regulations, which ended Sept. 5.

Cynthia Williams of Newport News-based Riverside Health System said that she supported the regulation and emphasized the lack of oversight to ensure that medications delivered in this way are not compromised.

“This not only puts the patient at risk, but puts the organization administering the medication at risk,” Williams wrote in a public comment. “For the most part, this practice is being driven solely for the financial benefit of insurance vendors, not for the benefit (or safety) of the patient or healthcare provider.”

Another commenter, Elizabeth Early, cited examples of medications sitting for hours in extreme temperatures when improperly delivered, waste when a delivered medication must be disposed of after a last-minute change to the prescription for the patient’s health, and delays in delivery endangering patients’ health and costing them financially when they must purchase new medicine.

Dr. Richard Ingram, president of the Virginia Association of Hematologists and Oncologists, wrote that his organization is “in strong opposition to ‘white bagging’ and ‘brown bagging,’ ” specifically for cancer medications, which he said require special care.

Just over a quarter of oncology drugs were distributed by delivery, according to the 2016 Genentech Oncology Trend Report, cited in the NABP report.

The proposed regulations will be subject to a 60-day comment period before the Board of Pharmacy holds an official vote, which would send them to Gov. Ralph Northam for final approval.

bbalch@timesdispatch.com

(804) 649-6601

Twitter: @bridgetbalch

Years ago there was a single test done on the mailing a prescription inhaler.  It was mailed to an address in the SW USA IN THE SUMMER… and after it arrived.. its potency was tested and it LOSS ABOUT 50% OF THE LABEL POTENCY.  If any entity has done any testing since… I have not seen any published data.

The FDA/USP has temperature storage requirement for most common meds somewhere between mid-50’s to mid-80’s.  Some medications .. like Fentanyl patches have a much lower temp storage requirements.. they use to state 72F-75F upper limit .. now they say “room temperature”.

As the laws now function, the pharma, wholesaler and pharmacy are required to maintain those storage requirement, but once a pharmacy hands off a prescription to be mailed to the carrier ( USPS, UPS, Fed-X).. they are not held to those storage requirement.

Where is the FDA/USP on this issue… or … is this just another area that the insurance industry’s lobbying power is able to get the bureaucrats to “look the other way”… since the insurance industry own the vast majority of these mail order pharmacies ?

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Steve’s email inbox

Posted on November 29, 2018 by Pharmaciststeve

I sent yours, can you forward mine? Please read 28th amendment Please Read, and forward. This will only take 1 minute to read! 28th Amendment, 35 States and Counting. It will take you less than a minute to read this. If you agree, please pass it on. It’s an idea whose time has come to deal with this self-serving situation: OUR PRESENT SITUATION ! Children of Congress members do not have to pay back their college student loans. Staffers of Congress family members are also exempt from having to pay back student loans. Members of Congress can retire at full pay after only one term. Members of Congress have exempted themselves from many of the laws they have passed, under which ordinary citizens must live. For example, they are exempt from any fear of prosecution for sexual harassment. And as the latest example, they have exempted themselves from Healthcare Reform, in all of its aspects. We must not tolerate an elite class of such people, elected as public servants and then putting themselves above the law. I truly don’t care if they are Democrat, Republican, Independent, or whatever. The self-serving must stop. Governors of 35 states have filed suit against the Federal Government for imposing unlawful burdens upon their states.It only takes 38 (of the 50) States to convene a Constitutional Convention. IF??? Each person that receives this will forward it on to 20 people, in three days most people in The United States of America will have the message. Proposed 28th Amendment to the United States Constitution: “Congress shall make no law that applies to the citizens of the United States that does not apply equally to the Senators and/or Representatives; and, Congress shall make no law that applies to the Senators and/or Representatives that does not apply equally to the Citizens of the United States …”

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