Do Opioid Restrictions Reduce Opioid Poisonings?

https://www.cato.org/blog/do-opioid-restrictions-reduce-opioid-poisonings

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Legalizing pot for SC medical use could bring ‘unintended consequences

http://www.myrtlebeachonline.com/news/state/south-carolina/article137373338.html

A state Senate panel spent much of Wednesday listening to the testimony of medical experts, who expressed support and concerns for a proposal to legalize medical marijuana in South Carolina.

It was the second of several hearings expected to take place in the coming months that are exploring a way for the Palmetto State to legalize the use of pot in a medical setting. Supporters say the plant’s chemicals could help those who suffer from chronic pain and other quality-of-life-damaging illnesses, such as post-traumatic stress disorder.

More than a dozen speakers addressed the Senate panel during a marathon hearing that ran for nearly five hours. The majority advocated legalization of the plant for medicinal use, with many arguing it could help those being treated for chronic pain be weaned off opioids and other dangerous narcotics.

Among those who spoke was Uma Dhanabalan, a Massachusetts-based physician who has become a cannabis therapeutic specialist in recent years. She said she has not written a prescription for an opioid in more than eight years. Instead, she said she gets patients off narcotics.

“Cannabis is not an entrance drug – it’s an exit drug from pharmaceuticals and narcotics,” Dhanabalan said. “Further studies do need to be done, but I do believe it should be a first-line option.”

Dhanabalan listed several ways studies have found medical marijuana has affected patients by helping them curb alcohol consumption, lose weight and spend less on prescription medications. She said “cannabis is not for everybody,” but argued that those in need should have access to it.

Physicians in states where medical marijuana is legal cannot write a prescription. But they can write a recommendation to be used at registered marijuana dispensaries.

Though the majority of speakers echoed Dhanabalan, a handful voiced concerns with the regulatory aspect of the legalization of medical pot.

J. Addison Livingston, a pharmacist and member of the S.C. Board of Pharmacy, said the proposed law creates a system “that is outside of normal practice.” He said the board is concerned about the bill moving forward without further research.

Livingston said he remembers a time when the use of opioids was advocated for, resulting in “unintended consequences.” He said there has not been enough analyzed evidence by the FDA to show the benefits of medical marijuana outweigh the risks.

“We do not need another situation like the opioid epidemic that we’re battling right now,” Livingston said.

The bill’s main author, libertarian Sen. Tom Davis, R-Beaufort, noted, however, the majority of the speakers kept repeating each other in saying that “cannabis is medicine.”

Sen. Kevin Johnson, D-Clarendon, voiced the strongest concern of legislators on the panel, stressing he was mainly worried about preventing medical marijuana from falling into the hands of those who would abuse it.

“I have no concern that there is benefit and that it provides relief to people,” Johnson said. “I want to make sure that if we pass a bill … that that’s who gets it.”

The panel ended the hearing without taking any action on the bill. It was the second meeting with no action.

A House panel already advanced in February a bill that also seeks to legalize medical pot over the opposition of members from the state’s law enforcement community, including State Law Enforcement Division Chief Mark Keel. Though Keel attended the Wednesday Senate hearing, he was not called on by legislators to speak.

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Assembly Speaker pours cold water on assisted suicide bill

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Docs warn that Medicare crackdown will hurt pain patients

http://www.politico.com/story/2017/03/docs-warn-that-medicare-crackdown-will-hurt-pain-patients-235917

A group of prominent pain and addiction specialists are pushing back against the federal opioid crackdown by asking CMS to withdraw a notice that would make it extremely difficult for Medicare patients to get painkiller prescriptions above a certain strength.

More than 80 physicians, including four who helped create the 2016 CDC guidelines on opioid prescribing, wrote to acting Medicare director Cynthia Tudor about the notice, which would require pharmacists to refuse prescriptions over 90 milligrams of morphine or its equivalent unless the patient first went through a complex, time-consuming review.

While the CDC guidelines caution that high doses create an overdose risk, they also state that physicians should have ultimate discretion on prescribing, and warn that it is not advisable for patients to be tapered off high doses of opioids involuntarily.

An estimated 5-8 million Americans use opioids to treat chronic pain. Many were started on the drugs before the risks were recognized. A 2008 study showed that half of non-cancer opioid patients in Medicaid and private insurance were getting doses above the threshold. While tapering off high doses is often advisable, pain doctors say it must be done carefully and with patient consent.

“CMS mandates will cause previously stable patients to suffer acute withdrawal with or without medical complications, including death,” says the letter, which states that the CMS rule, buried deep within a Feb. 1 CMS payment document, is “in tension with the spirit and the letter of the CDC Guideline.”

Pain and addiction specialists largely agree that doctors saddled too many patients with high doses of opioids in the decade before 2010. Yet some of these patients are medically stable on high doses, and others can’t access the complex care needed to wean them off without tremendous suffering.

“There’s little question that the license given to doctors to reduce pain … was too much,” said Jeffrey Samet, past president of the American Board of Addiction Medicine. “But the pendulum has swung too far in the opposite direction.”

To be sure, there were more than 20,000 deaths linked to prescription painkillers in 2015. Since 2012, though, opioid prescribing and deaths have gradually declined, while deaths from heroin and fentanyl, a powerful synthetic opioid, continue to skyrocket.

“What caused the epidemic and what sustains it today are not the same,” said Stefan Kertesz, a University of Alabama internist and addiction specialist.

The comment period for the CMS rate announcement rule, which takes effect April 3, ended last Friday. Asked to respond to the critique, CMS said its notice followed CDC expert guidelines.

CMS is not the only agency that is tightening the screws on high-dose prescribers.
Under new guidelines under consideration by the National Committee for Quality Assurance, health care providers who provide patients more than 120 milligram morphine equivalents daily over a three-month period would have points taken off from their quality scores.

Already, prescription drug monitoring programs are getting better at detecting patients who doctor shop and doctors who overly prescribe. Many doctors have cut doses or “fired” high-dose patients, and there are anecdotal reports of suicides and heroin deaths among patients who lost access to the medications they were using.

Some of these patients are in such pain that the “just lie in bed or watch TV all day,” said James DeMicco, whose Hackensack, N.J., pharmacy services a major pain clinic. About two-thirds of the opioid patients he serves get more than the CMS-proscribed dose, he said.

The CMS rule could inconvenience pain patients without having much impact on mortality, Kertesz said, because opioid fatalities are increasingly heroin-related.

Data from Birmingham, Ala., for example, show that since 2010, prescription opioid deaths have stabilized at about 50 per year, while heroin deaths surged from 3 in 2010 to 92 in 2016, and fentanyl deaths jumped from 0 to 92. In Cleveland, where 494 people died of opioid overdoses in the first eight months of 2016, 424 were from fentanyl. In Massachusetts, only 8 percent of those who died of overdoses over a three-year period had been prescribed opioids at the time of their deaths.

Though skeptical of the CMS rule, many pain and addiction specialists agree that most high-dose patients would function better if tapered down. They are also less likely to die of an overdose, notes Paul Hilliard, chairman of the Hospital Pain Committee at the University of Michigan health system.

“Blanket statements and policy should never substitute for sound clinical judgment,” said Hilliard. “I do, however, support the notion that any patient on high-dose opioids deserves a review of the medication and treatment strategy. “

“I just don’t see that many patients on high doses who are working full time, coaching the kids’ soccer team, or volunteering at soup kitchens,” he said. “And they continue to report high pain levels.”

Patients who benefit from high doses of opioids are “more the exception than the rule, in my practice,” said Jane Liebschutz, a Boston Medical Center physician. “But the ones who do need it I’d go to bat for. The rules CMS is putting out would make it more difficult for patients and doctors.”

Federal officials have been campaigning hard against prescription drug abuse but are beginning to show concern about unintended consequences.

In a New England Journal of Medicine article in December, Surgeon General Vivek Murthy noted that while prevention and increased treatment are needed to lower opioid abuse, “we have to do all these things without allowing the pain-control pendulum to swing to the other extreme, where patients for whom opioids are necessary and appropriate cannot obtain them.”

NIH officials are also wary of unintended consequences. Federal surveys show that roughly 80 percent of heroin users got started on opioids through prescription drugs.

There is no evidence that pain patients weaned off of opioids turn to heroin in large numbers, but it’s possible that street drugs can become an option “when their other drug of choice becomes unavailable,” and the issue needs more study, said Wilson Compton, deputy director of the National Institute of Drug Abuse.

Doctors who decide to taper off an addicted patient need to help find them treatment, he said. But treatment is expensive and waiting lists to get into decent programs are long in opioid epidemic-stricken regions of the country. A new law would vastly expand treatment, but first Congress has to fund it.

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North Carolina Drug Control Bill Seeks to Add More Restrictions on Doctors, Pharmacists

www.claimsjournal.com/news/southeast/2017/03/08/277262.htm

North Carolina lawmakers can save patients’ lives, spare their families and combat an ongoing opioid-abuse crisis by putting tighter controls on physicians and pharmacists who hand out powerful pain-killing medicines, supporters of a drug control bill said Thursday.

The plan announced by Republican lawmakers and new Democratic Attorney General Josh Stein would put new restrictions on medical providers who prescribe and dispense opioid drugs like OxyContin and morphine and limit their public supply. Such drugs carry a high risk of addiction and are often considered a gateway to the use of heroin and other illegal drugs. The bill also includes $20 million over two years for local substance abuse treatment and recovery services.

One of the chief sponsors, Sen. Tom McInnis, R-Richmond, said his stepson died in 2007 at age 22 after a fight with drug addiction he said intensified when he was prescribed an opioid following an automobile accident.

“We lost a beautiful vibrant wonderful son to this epidemic,” McInnis said at a Legislative Building news conference. “He was given a vial of these horrid, horrid addictive drugs and he started a downhill spiral that ended up with the loss of his life.”

Nearly 250 heroin deaths were reported in North Carolina in 2014, a more than five-fold increase from 2010, according to state health statistics. Four North Carolina residents die every day from drug and medication overdoses, backers of the bill said. Many more are hospitalized or go to emergency rooms.

“Opioids are tearing families apart all across our state. Too many of our neighbors, co-workers and family members are dying,” Stein said.

The measure would require physicians to log on to the state’s controlled substance database system and examine a patient’s prescription history to prevent overprescribing. Such information could show when abusers go to multiple physicians seeking prescriptions for their favored drug. Doctors would pay a $20 annual fee to keep up the system.

Pharmacists also would be required to register with the system and report controlled substance transactions within 24 hours. Pharmacy registration is essentially encouraged now and transactions now can wait 72 hours. Those who don’t file proper reports could be fined.

Doctors also would have to prescribe controlled substances electronically to reduce fraud. In most instances they would be limited to initially prescribing no more than a 5-day supply of a controlled substance for treatment of “acute pain.” This would stop 30-day supplies that bill supporters say can lead to addiction or unused pills left in medicine cabinets for young people to take. State health officials would audit prescriber records.

Bill sponsor Rep. Greg Murphy, R-Pitt and a physician, said some of the restrictions place more “bureaucratic hassle and paperwork” upon doctors, but it’s worth it.

“Our goal here is to save lives, to save families, to save businesses and it is an honorable and laudable and I believe attainable goal that we all must be willing to make sacrifices to achieve,” Murphy said.

The measure also would expand a 2016 law that created a statewide standing order at all pharmacies for access to a prescription drug that can reverse overdoses of opium-based drugs.

The bill would need House and Senate approval before going to Gov. Roy Cooper’s desk. Cooper’s proposed state budget includes $14 million to treat and combat opioid-related drug abuse and overdoses.

Stein said he would soon convene a task force of law enforcement officials to recommend new criminal charges for opioid drug dealers.

Ethan Buck of Greenville, who began using prescription opioids at age 12, advanced to heroin before becoming homeless and finally getting help. Now 20, Buck attended Thursday’s event and warned drug addiction can happen to anyone no matter their education or status.

“It’s not a disease that discriminates,” Buck said.

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Cadden Seeks Acquittal on All Charges

http://meningitis-etc.blogspot.com/2017/03/cadden-seeks-acquittal-on-all-charges.html

BOSTON, Mass.- The head of a drug compounding firm blamed for a deadly fungal meningitis outbreak is asking a federal judge to acquit him on all charges, including racketeering and 25 counts of second degree murder.
In a 38-page motion filed today in U.S. District Court, Cadden’s attorneys are charging that federal prosecutors failed to present adequate evidence of second degree murder though they conceded the evidence might support “at most” a manslaughter charge.
The motion, which was not unexpected, comes as federal prosecutors are about to call their last witness in a trial that began in January.
In testimony today a former employee described how she and a colleague created dozens of phony prescriptions to present to state officials in response to a complaint that had been filed against Cadden’s company, the New England Compounding Center.
Cadden has been charged in only 25 of the 76 deaths recorded in the 2012 fungal meningitis outbreak. He was one of 14 to be charged in late 2014 following a lengthy grand jury probe. Charges against two defendants have been dismissed, Two others pleaded guilty to reduced charges with the remaining facing trial later this year.
Cadden’s motion states that federal investigators, despite spending years on the case, still could not explain how vials of methylprednisolone acetate became contaminated with fungus.
“The fact that 25 (people) died is not in dispute,” the motion states, adding that federal investigators never found evidence at NECC of the specific fungus, exserohilum rostratum, that was found in the bodies of victims and unopened vials of NECC steroids.
“Despite calling over 50 witnesses over 41 days, the government has failed to prove what caused the contamination,” the motion states, adding that Cadden did not compound the steroids that caused the outbreak.
The government, the motion continues, “has provided no evidence that Cadden acted with the requisite intent to commit second degree murder.”
Calling the murder charges unprecedented for “a participant in a non-violent business,” the motion concludes, “The court should exercise its extreme discretion to grant the motion for acquittal.”
At the court session Beth Reynolds, who worked for NECC’s sales arm, Medical Sales Management, said that one of her duties was to ensure that pharmacists and technicians were properly licensed and registered.
A hesitant witness who spoke at times in whisper soft tones, Reynolds said she and another worker were assigned in 2012 to take patient names from a list at the Mass. Eye and Ear Infirmary and insert them on prescription forms.
According to previous testimony, the drugs in question already had been delivered to Mass Eye and Ear without patient specific prescriptions as required under state law. In fact the drug, a numbing agent, already had been administered to patients.
Reynold’s assignment followed a complaint the health facility had filed with the state Pharmacy Board against NECC. The complaint charged the drugs that didn’t have the required potency, prompting complaints from patients and doctors.
The witness identified a series of emails relating to the project.
“The labels have all been created, printed and proofed,” Reynolds wrote in one email.
She said that both she and her colleague, Michelle Rivers, thought the project was “out of the ordinary.”
She said she didn’t like another 2012 assignment from Cadden, which was to compile a list of states that allow prescriptions to be filled under certain circumstances without the name of a patient. Under so-called office use provisions set quantities of drugs can be dispensed for use in a hospital or doctor’s office in situations where the patient’s identity can’t be determined in advance.
She said the assignment made her feel uncomfortable and she did not know what was going to be done with the information.
An official of the Massachusetts Pharmacy Board later testified that there is no such exemption from the patient specific requirement for pharmacies, like NECC, licensed in Massachusetts.
Other witnesses provided additional testimony and evidence about the Mass Eye and Ear Infirmary incident including an email from Cadden with instructions on the need to insert patient names in each prescription.
Contact: wfrochejr999@gmail.com

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Clarence Scranage, Jr., MD

www.doctorsofcourage.org/index.php/2017/03/08/clarence-scranage-jr-md/

Clarence Scranage Jr., MD, 61, of Richmond, VA is the next doctor illegally persecuted by the government for money. He was indicted Feb, 2017 on a charge of conspiracy to possess controlled substances with the intent to distribute them and 18 counts of distribution of controlled substances.

All of the news media reported the exact same information, so it is obviously government propaganda that they copied from the indictment. The news media also brought out past government attacks to paint Dr. Scranage in as bad a light as possible. They should have nothing to do with the current situation and poor reporting like that makes a fair trial impossible. Also, the attacks mentioned are usually planned government attacks created for the purpose of leaving a paper trail.

Dr. Scranage meets all the criteria for doctors that are specifically targeted for attack by the government:

1. Older (so they can forfeit all assets—savings, property, etc) Yep—proven by the fact that the indictment seeks the forfeiture of $650,000 they base on these prescriptions
2. Minority,
3. Primary care who moved into pain management. Dr. Scranage was board certified in Emergency Medicine, but developed his pain management practice involving 3 clinics in the Richmond area.

According to the indictment, Dr. Scranage was in a conspiracy with Anthony Harper, who has pleaded not guilty to all 19 charges. Prosecutors claim Harper simply gave names of people to Dr. Scranage who then wrote prescriptions which Harper then paid for. Is anyone really gullible enough to believe that, in today’s pain management-attacking world?

And the charges are the standard illegal government maneuvering in order to charge a legitimate physician with criminal activity. From the media information, it can be gleaned that the people recruited by Harper did come to see Dr. Scranage as patients. They were evaluated and received legitimate prescriptions for their diagnosis. But because they acted fraudulently, the government uses that as an avenue to attack the doctor. If people present to a doctor fraudulently, THEY have committed a crime. But the government doesn’t get as much through attacking them as they do the doctor, so they ignore the illegal activity of the fraudulent patient, and instead, make deals with them for false testimony to use against the doctor.

The indictment accuses Scranage of repeatedly failing to individually assess the medical needs of the people for whom he wrote prescriptions. But if he saw the patient and prescribed medication, then he assessed the medical needs. It’s the government breaking the law by illegally misinterpreting the CSA.

I just hope Dr. Scranage also pleads NOT GUILTY!  I’m going to be at his trial and will give him support any way I can, hopefully through testimony. Please contact me, Dr. Scranage.

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UPDATED: KPD officer allegedly stole Fentanyl from woman

http://www.kokomotribune.com/news/local_news/updated-kpd-officer-allegedly-stole-fentanyl-prescription-from-woman/article_58a49e6a-0426-11e7-8890-0741438c76d7.html

KOKOMO – Kokomo Police Department officer Heath Evans was charged Wednesday with two felony drug counts and misdemeanor theft for allegedly stealing Fentanyl from a local woman in December.

Evans, who was the focus of an internal KPD investigation, was charged with a felony count of obtaining a controlled substance by fraud or deceit; a felony count of possession of a narcotic drug; and misdemeanor theft. A warrant was issued for Evans’ arrest today and bond has been set at $10,000.

Evans’ initial appearance is set for 9 a.m. March 16 in Howard Superior Court I.

According to a probable cause affidavit, Evans responded to a welfare check for a woman named “Nancy” on Dec. 22, after Nancy’s friend called police to say she was worried about Nancy’s wellbeing.

After speaking with Nancy and leaving the residence, Evans reportedly returned to the home to ask Nancy if there was anything further he could do for her.

Nancy told Evans that she needed her prescription picked up from a doctor’s office and then filled at the CVS Pharmacy located at Sycamore Street and Dixon Road, according to court documents. Originally, Evans told Nancy that he could drop off the prescription and Nancy could have a friend pick it up.

Approximately 30 minutes later, however, Evans returned to Nancy’s home, providing her with an unstapled pharmacy bag. Nancy found the situation to be “odd and peculiar” as her prescription bag of Fentanyl patches are always stapled and include two boxes, according to the affidavit.  

Only one box was in the bag given to Nancy.

After Nancy questioned Evans, he told her, “That’s what they gave me.”

Evans then sat down and began to question Nancy on how to apply Fentanyl patches, asking her where she puts them on her body, according to the affidavit. At Evans’ request, Nancy even changed her Fentanyl patch and applied a new patch. Fentanyl, a powerful synthetic opioid analgesic, is used to treat severe pain.

In an interview with KPD investigators, Nancy said that because of the theft “she is suffering both mentally and physically.” Nancy’s interview with police was conducted on Jan. 12.

On Jan. 13, KPD Detective Derek Root went to the CVS at Sycamore Street and Dixon Road and spoke with the store manager, who provided Root with video of the Dec. 22 incident.

Root also acquired the pharmacy label printout of Nancy’s prescription for Dec. 22 for two boxes of Fentanyl, 50 microgram patches, with five patches in each box.

Root also was given a CVS signature log and a copy of the prescription. A CVS Pharmacy tech later confirmed that Evans picked up two boxes of Fentanyl patches.

In the affidavit, Root says he made several attempts to meet and speak with Evans about the situation, but that Evans initially advised him to speak with his attorney. Despite speaking with Evans’ attorney, no interview or statement was given by early February.

On Feb. 21, Root received a sealed envelope from KPD Capt. Shane Melton, which contained lab results from Evans’ urine screens. The sealed envelope was given to Melton from Howard County Prosecutor Mark McCann. Root had previously completed a subpoena request for lab results of Evans’ urine screens.

The urine screen showed a positive test for the presence of Fentanyl, after which Root requested an arrest warrant.

Evans was put on administrative leave without pay following the reading of a memorandum from KPD Chief Rob Baker at Wednesday’s Board of Public Works meeting.

In a press release, McCann said “the case is still under investigation and anyone having information concerning this case should contact the Kokomo Police Department or the Howard County Prosecutor’s office.”

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Class action: Walgreens, CVS, Osco overcharging diabetics on Medicare for insulin pumps, supplies

http://cookcountyrecord.com/stories/511087986-class-action-walgreens-cvs-osco-overcharging-diabetics-on-medicare-for-insulin-pumps-supplies

A Geneva resident who says pharmacies are overcharging people with diabetes for medication is pursuing a class action complaint against some of the country’s largest retail drug stores in Chicago federal court, seeking at least $5 million. 

Robert Mayberry filed his complaint March 3, naming as defendants Walgreens, CVS Pharmacy and Osco Drug parents Albertsons and Supervalu. He accused each pharmacy of improperly processing claim payment and reimbursement of insulin pump supplies, which are supposed to fall under Medicare Part B, resulting in customers paying more than their intended share. 

Not only do these customers pay more out of pocket, the complaint continues, they also reach Medicare Part D limits faster, thereby incurring out-of-pocket expenses for other prescriptions that are supposed to fall under Part D, until they reach Medicare’s catastrophic coverage threshold. In 2016, Medicare participants were completely responsible for Part D drugs after reaching $3,310 in plan purchases until they’d spent $4,850 out of pocket. 

According to the complaint, Part B covers medical services required for people with diabetes as well as some preventive services for Medicare beneficiaries considered at risk for diabetes. Specifically, this includes external insulin pumps and insulin for those pumps. Part D covers anti-diabetic drugs, including insulin, and supplies needed for inhalation or ingestion. 

The distinction, per Mayberry’s complaint, is that “most health insurance plans, including Medicare and Medicaid” classify an insulin pump and supplies — which includes the drug itself — as durable medical equipment. He further alleges the pharmacies are motivated to misclassify these purchases in pursuit of profits because the Center for Medicaid Services has cut its rate of reimbursement for the products. The pharmacies make more money when patients pay out of pocket. 

Mayberry said he’s been on Medicare since 1996 and has had type 2 diabetes and used insulin to control blood glucose for about 35 years. He said for the last 15 years, he’s had a prescription for an insulin pump. On Feb. 23, 2016, his Part D coverage supplier, WellCare, sent him a denial of benefits notice regarding insulin, which is when he said he realized he’d been improperly paying out-of-pocket expenses for years. 

The complaint accuses the pharmacies of fraudulently concealing their claims reimbursement processes, depriving customers of the ability to learn they were paying too much and overextending their Plan D contributions. That concealment, Mayberry contends, tolls any statute of limitations defense. 

Formal allegations include a violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, as well as similar laws of other states, common fraud by omission and unjust enrichment. 

The pharmacies, Mayberry alleges, “continuously and consistently failed to disclose to consumers … the defective claims process concerning insulin prescribed for use via pump (and) failed to make these disclosures despite opportunities through” employees, advertising, websites and sales literature. 

The class would include all Medicare or Medicaid plan participants who obtained an insulin pump from the named pharmacies from 2006 through the present. 

In addition to class certification and a jury trial, Mayberry’s complaint seeks restitution, compensatory damages, punitive, statutory and treble damages, as well as attorney fees and interest. He also wants the court to compel the pharmacies to establish a program to reimburse customers for Medicare claims related to insulin pumps that were previously denied or insufficiently paid. 

Representing Mayberry in the matter, and serving as putative class counsel, are attorneys with the Clifford Law Offices, of Chicago.

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