Health Insurers questioning all the EXPENSIVE urine tests to catch drug abusers ?

rockhardplaceLabs, doctors scrutinized over lucrative drug tests for pain-pill abuse

http://www.11alive.com/story/news/arizona/investigations/2015/12/26/labs-doctors-scrutinized-over-lucrative-drug-tests-pain-pill-abuse/77181470/

Doctors frequently order patients to take urine drug tests to safeguard against prescription pain-pill abuse.

But federal investigators and Medicare say these routine tests — designed to ensure patients properly use opioid drugs — have led to questionable billing practices by some for-profit labs, doctors, and addiction-treatment centers.

Millennium Health, the nation’s largest lab and one that has conducted widespread testing in Arizona, agreed to pay $256 million to the federal government in October to settle claims that it conducted unnecessary testing.

The U.S. Department of Justice is cracking down on private labs that investigators say offer incentives to doctors to frequently refer patients for lucrative testing. And Medicare, citing the potential for billing abuses, is overhauling its billing codes and payment rates used for drug tests.

Consumers who have been hit with large bills for routine tests say that the cost can quickly become unaffordable.

Phoenix resident Eric Smith visited a local pain clinic in June for treatment of pain from a degenerative disc in his back. The doctor approved a 30-day prescription for Percocet  but also required Smith to submit a urine sample each month he sought a refill.

Weeks later, Smith received an itemized bill for a urine test that listed five separate charges for a total charge of $660. He decided monthly tests and other fees such as co-payments and prescription-drug charges would quickly become too expensive.

“This is something I’m dealing with long term,” Smith said. “For those of us with real pain who have to pay for these tests because of the few who abuse (prescription painkillers), it does not seem fair.”

Some tests can be even more expensive. A 75-year-old Fountain Hills man visited the same practice, Arizona Pain Specialists, which has seven clinics in Arizona. He had a urine test that checked for 10 substances, including illegal drugs such as methamphetamine, cocaine and phencyclidine, more commonly known as angel dust. The man was billed separately for each substance for a total bill of $1,048. His insurance plan paid $412.

Doctors who prescribe pain pills frequently say they must order screening tests to comply with medical guidelines.

Arizona Medical Board guidelines encourage doctors to conduct regular urine drug tests on patients who take prescription pain pills. The screens are designed to make sure patients take the prescribed drugs, don’t resell the drugs and don’t mix prescriptions with illegal street drugs. Frequent testing also is a hallmark of addiction-treatment centers, which also have been scrutinized by federal investigators and private insurers.

The medical board has suspended or revoked licenses of doctors who it determined prescribed opioids without proper oversight.

That oversight, according to the medical board’s guidelines, should include “regular toxicologic testing for drugs of abuse.” The guidelines don’t specify which drugs of abuse doctors should test, or how often tests should occur.

Too much testing a concern

Labs and clinics in Arizona and other states use sophisticated tests that measure multiple substances and charge for each individual substance tested, providing more revenue than basic screening tests. Too much testing has long been a concern of Medicare due to potential overbilling, a Centers for Medicare and Medicaid Services spokesman said.

That’s one reason Medicare, the federal health program for the disabled and those 65 and older, is overhauling the way it pays for these tests. Beginning in January 2016, labs and doctors must limit Medicare charges to two categories of billing codes. And in January 2017, Medicare will change payment rates for drug testing.

A Medicare official said the changes aim to remove the incentive for too much testing that has little or no medical benefit.

Medicare wants to reduce the frequent use of confirmation tests by labs that charge for follow-up tests when initial tests show no sign of an illegal substance. Medicare says that some confirmation tests are not medically necessary and inflate charges for taxpayers who support Medicare.

Private health insurers also are scrutinizing and changing payment policies for urine screens ordered or performed by pain doctors, addiction-treatment centers and labs.

“The lab industry has done a lot of over-testing,” said Jennifer Bolen, a former assistant U.S. Attorney in Knoxville, Tenn., who consults on proper opioid screening. “Some of it was encouraged by a lack of sound boundaries (through guidelines). Some of it was pure greed.”

Doctors say they follow guidelines

Doctors who treat patients for chronic pain say they must adhere to state and federal guidelines on how to safely prescribe pain pills. They say they also must keep patients safe from the ravages of pain-pill addiction.

Overdose deaths from opioid prescriptions surged fourfold nationally from 1999 through 2010. Arizona had the fifth-highest opioid prescription rates in the nation in 2010 and was sixth highest in drug overdose deaths.

Arizona has since made small strides in reducing the death rate from drug overdoses. A total of 1,211 Arizonans died from drug overdoses in 2014, a slight drop from 2013. Thirteen states had a higher overdose rate than Arizona in 2014, according to the federal Centers for Disease Control and Prevention.

The CDC recently drafted guidelines that recommended urine testing for pain patients. Arizona doctors who treat chronic-pain patients say state and federal guidelines are instructive.

“Right now, urine testing is really not an option. It is (a) standard of care,” said Patrick Hogan, an anesthesiologist who runs a Glendale pain clinic. “If you are failing to test and you have a patient who has a complication, there is a high likelihood that you would face some disciplinary action from regulatory agencies.”

Doctors who frequently order drug tests for patients will need to navigate Medicare’s new billing requirements.

Medicare billing records show that Hogan ordered the most urine drug screens of any Arizona doctor in 2013. He billed Medicare for 1,943 tests on 368 patients — an average of 5.3 drug screens per patient that year, Medicare records show.

Hogan said that he does not know of any guidelines that limit how often a doctor should order a drug test for a patient. Some larger doctor groups may have their own testing frequency requirements. Hogan said he does not want limits on how often doctors can test.

“How often do you test somebody? I don’t know that there are clear guidelines that exist for something like that,” Hogan said. “I would hate to see something that would usurp provider judgment on that.”

Lisa Sparks, an addiction-medicine doctor and medical director of the Arizona Pain Institute in Glendale, said she decides how often each patient should be tested based on their circumstances. However, Sparks believes routine testing makes “patients realize they can’t cheat the system very easily” by misusing or selling their prescribed drugs.

She often orders panels that tests for multiple substances for patients who are on pain medications, but those tests vary based on the patient. For example, she said she does not test patients for the illegal street drug angel dust because it’s so rarely found in the community.

“We try to avoid overbilling and (limit panels) to do the tests that really need to be done,” said Sparks, who billed Medicare for 741 drug screens on 232 patient in 2013, Medicare records show.

Doctors in other states have been more prolific in billing for these tests. For example, one Connecticut doctor charged Medicare for an average of 198 tests per patient in 2013, Medicare billing records show.

Labs face closer scrutiny 

Labs that market tests in Arizona and elsewhere have been subject to enforcement actions and legal settlements.

Millennium Health, a San Diego-based laboratory, in October agreed to pay the federal government $256 million to settle claims that it billed Medicare for improper testing.

The U.S. Department of Justice said that Millennium billed Medicare and Medicaid for unnecessary urine and genetic tests over a seven-year period through May 2015. The company gave doctors free testing cups in exchange for patient referrals, resulting in unnecessary and lucrative testing, federal investigators said.

Millennium Health, previously known as Millennium Laboratory, was the subject of multiple civil lawsuits — including one in Arizona — that alleged billing improprieties. One Arizona-based regional sales manager alleged that sales representatives routinely offered medical practices free urine-testing cups to encourage doctors to order tests.

The lawsuit filed in U.S. District Court in Arizona alleged Millennium gave gifts such as Starbucks gift cards to doctors offices “to both retain existing business and assist in generating additional business.” At the time of the 2012 lawsuit, Millennium denied offering such inducements. The case was dismissed in April with no award to the sales manager.

Millennium officials said the company decided to settle the Justice Department’s multiyear investigation. The company filed for Chapter 11 bankruptcy in November.

“While Millennium may debate some of the merits of the DOJ’s allegations, we respect the government’s role in health care oversight and enforcement,” Millennium CEO Brock Hardaway said in a statement about the settlement. “At the end of the day, it was time to bring closure to an investigation that began nearly four years ago.”

Millennium isn’t the only lab that has caught the attention of investigators and health insurers.

In July, Cigna exited the Affordable Care Act individual marketplace in Florida for 2016 due to an “exponential increase in fraudulent and abusive care delivery practices” among substance-abuse clinics and labs, a Cigna spokesman said.

Cigna also sued Sky Toxicology and two related labs and alleged a “lucrative and improper patient-referral kickback scheme” that connected health clinics with out-of-network labs that resulted in $20 million in excess payments.

The lawsuit alleged that the labs sought doctors and drug-treatment centers that performed enough drug tests to meet a minimum number of referrals to the labs each month. If the doctors and treatment centers met a quota, the suit alleged, they would receive dividend payments based on the lab’s profits, the lawsuit alleged.

Sky Toxicology has denied the allegations, filed a motion to dismiss the lawsuit and is now engaged in settlement talks with Cigna, court filings show.

Richey Wyatt, general counsel for Sky Toxicology, said the lab has decided to wind down operations by the end of this year. He said the decision the shut the lab was due to a “changed landscape” for the lab business and not a result of the Cigna lawsuit.

Cigna spokesman Joseph Mondy said that the insurer only exited the individual marketplace in Florida, and he said other non-marketplace plans are available there. The company still sells marketplace plans in Arizona because the insurer is “not seeing this type of activity” in Arizona.

In 2013, another insurer, Horizon Blue Cross Blue Shield of New Jersey, sued Florida-based Avee Laboratories and a home for those seeking addiction treatment. The health insurer alleged that the sober house collected and sent patients’ urine samples to Avee, even when such testing wasn’t medically necessary. Avee denied it performed medically unnecessary testing

A Scottsdale-based sober house, Scottsdale Recovery Center, routinely sent urine samples to Avee Laboratory, but it switched to another lab about two years ago because Avee would take too long to complete tests, said Scottsdale Recovery Center co-founder and CEO Alex Salcedo.

Salcedo said Scottsdale Recovery Center, which provides sober-living homes mainly for young adults battling drug and alcohol addiction, typically tests its clients three times a week. The maximum amount billed per test is $1,400, Salcedo said, but he said Scottsdale Recovery often takes lower payments from insurers and consumers don’t pay out of pocket.

Salcedo said the nature of substance-abuse recovery requires frequent testing to make sure patients are not cheating themselves. He said Scottsdale Recovery chose to send urine samples to an out-of-state laboratory because it was among the largest labs in the industry.

Deterrent effect questioned

Some pain-management experts question whether urine drug screens stop abuse or resale of pain pills.

“There is not much evidence that it helps deter use,” said Lynn Webster, past president of the American Academy of Pain Medicine. “Even the CDC (Centers for Disease Control and Prevention) guidelines are recommending urine drug tests, but they don’t state how these will be paid … I have seen bills of $700 to $800 on a monthly basis. It is unaffordable. It is absurd.”

Other doctors say that urine screens are not a fail-safe method to prevent patients from diverting pain pills — filling a prescription and then reselling the pills instead of taking them for pain needs.

Dr. Mohab Ibrahim, a University of Arizona pain specialist, said monthly urine screens can be gamed by a dishonest patient. A patient who takes medicine days in advance of a scheduled urine screen may be able to mask weeks of not using the medication.

“The urine test is mostly performed by physicians to satisfy legal and regulatory grounds, but its medical value as a measure of adherence to a treatment plan is questionable,”  Ibrahim said.

Republic reporter Rob O’Dell contributed to this article.

Our elected Federal politicians BAIL on MJ/MMJ bill as they dashed out of town for Xmas break ?

Congress: A Buzzkill for Weed in 2015

http://www.thedailybeast.com/articles/2015/12/28/congress-a-buzzkill-for-weed-in-2015.html

While 2015 was a great year for weed on the state level, federal lawmakers still proved pretty square.

For pot fans, 2015 was a money year on the state level but Congress proved a reliable buzzkill, yet again, for the greenest lobby in town.

In the rush to get out of Washington for the holiday, Pollyanna-ish lawmakers used the year end government funding bill to kill most every new proposal to continue the state-lead effort to basically make marijuana the national plant. As in: States are embracing greenery, while members of Congress are still hiding their stashes.

Even a few years ago talk of sanctioning the use of weed was seen as a fringe issue in Washington, and the strength of the nationwide movement isn’t lost on even the stuffiest suit at the Capitol.

But still, the majority of those suits just weren’t ready loosen up.

The last minute budget deal continued the prohibition on allowing weed to be regulated like alcohol in the nation’s capital.

(Now, it’s technically illegal to sell or buy weed in D.C. because of the limitations Congress has put on the federal city. But it’s fine if you have a couple ounces on you.)

But the bad news extends beyond D.C. and into states with the lenient marijuana policies.

Another provision that was stripped out of the spending bill behind closed doors would have allowed growers and businesses in states where pot is legal to access the banking system. Currently, banks fear prosecution for dealing with marijuana businesses. Once again, by cutting the banking language, Congress supported maintaining the Wild Wild West, even as marijuana business owners are begging to pay taxes and turn their large cash holdings over to banks.

Yet another piece that was ingloriously left on the drafting room floor would have been a game changer for medical marijuana and, potentially, for the nation’s wounded veteran population.

The provision would have allowed Veterans Affairs’ doctors in states where medicinal marijuana is legal to prescribe weed to veterans.

The removal of that one really stung advocates.

“That’s a shame that that was stripped out,” Rep. Jared Polis (D-Col.) told The Daily Beast. “Because VA doctors can prescribe much harsher narcotic drugs than marijuana, including highly addictive pain killers, so in cases where marijuana might work and it’s a milder narcotic option, its use should surely be considered.”

“It was a great year, because we did very well on floor votes. We won every floor vote except for one and we lost that one narrowly,” Rep Jared Polis

But it’s not all coal for pot proponents in 2015.

For one, you know it’s a new day in Washington when top staffers for Majority Leader Mitch McConnell, Speaker Paul Ryan and the heads of the powerful spending committees at the Capitol are even discussing relaxing marijuana laws, as they did while debating what provisions to include and which to cut in the year end government funding bill.

Legalization proponents say they also won key battles on the House floor, and narrowly lost a few battles that could portend well for weed’s future.
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Back in June the full House voted to prohibit the Justice Department from interfering with state medical marijuana laws. In a major change from year’s past, 67 Republicans supported it, according to the advocacy group Marijuana Majority.

Proponents saw this as a sea change.

“We had no leverage behind the scenes except what the conferees thought were issues of importance,” Rep. Dana Rohrabacher (R-Ca..) told The Daily Beast. “And they considered ours important enough, passed by both houses of Congress, to include.”

Lawmakers are still applying pressure to the D.E.A. to fully abide by the their legislative language.

“If the D.E.A. continues to prosecute medical marijuana people in those states where the state has legalized it, it is the D.E.A. that is the criminal,” Rohrabacher said using words that could have lost him his seat a few years ago. “The D.E.A. is breaking the law. I’ve had to write several letters to judges indicating that. Our intent is clear.”

And this year a vast majority of House lawmakers—nearly 300, including 118 from the GOP—voted to ban the DOJ from trying to block states from giving marijuana oils to mostly children suffering from epilepsy.

“It was a great year, because we did very well on floor votes. We won every floor vote except for one and we lost that one narrowly,” Polis said, referring to the veterans provision. “So on all the key issues, I’m confident that a majority of the House of Representatives agrees that states should have increased discretion to regulate marijuana as they see fit.”

Lawmakers are still applying pressure to the D.E.A. to fully abide by the their legislative language.

“If the D.E.A. continues to prosecute medical marijuana people in those states where the state has legalized it, it is the D.E.A. that is the criminal,” Rohrabacher said using words that could have lost him his seat a few years ago. “The D.E.A. is breaking the law. I’ve had to write several letters to judges indicating that. Our intent is clear.”

The intent of the pot proponents of Capitol Hill is clear.What’s unclear is if anyone—even the government agents tasked with carrying out Congress’ policy—is listening.

 

 

virtually every pharmaceutical company has been rigging tests for years to make the drugs we take look safer than they really are

U.S. needs better regulation of drug development

Over the last weeks, we have learned that major companies that make products we trust, like Volkswagen’s diesel engines and Takata’s air bags, have devised ways to rig test results so they look cleaner and safer than they really are. Yet far more widespread manipulation of test results is being done by pharmaceutical companies to get drugs approved by the U.S. Food and Drug Administration that turn out not to be as safe as promised.

In the pharmaceutical industry, virtually every company has been rigging tests for years to make the drugs we take look safer than they really are. Some of the techniques for rigging clinical trials are described in a recent assessment published by BMJ (formerly known as the British Medical Journal). They include drawing random samples for clinical trials from a population that exclude older people, women, and people with multiple health problems who may be more likely to have adverse reactions. The resulting “safety” of the drugs misleads physicians and their patients.

Other techniques include using high doses in shorter trials in order to produce positive results before adverse reactions become evident. Only later do patients learn about them the hard way. FDA regulations also allow companies to run multiple trials (at great expense, used to justify high prices) and handpick the most positive ones while obscuring evidence of toxic reactions.

Worse, unlike regulators for cars, planes, electronic devices, and appliances, who work to detect and stop rigged testing, the FDA division that reviews new drugs has long known about the ways that companies bias trials. This puts patients at serious risk. Based on reviews of hospital clinical charts, independent experts estimate approximately 128,000 patients die each year from adverse responses to properly prescribed drugs. And 2.7 million are hospitalized due to drug reactions. Those estimates do not even include problems related to over-prescribing, errors, and self-prescribing.

 

Exactly which drugs approved by the FDA’s fast-track process have proved most dangerous to consumers? Given the central importance of drugs in modern medicine, you would think there would be a comprehensive tracking system at the FDA to provide this information by drug. But there isn’t.

In fact, perhaps the most famous such failure is Vioxx, which Merck finally withdrew – following years of obfuscation – after it was estimated to have killed about as many people as the U.S. military lost in the Vietnam War. Note, it was the manufacturer that pulled the drug, not the FDA.

But there are many examples. Worst Pills, Best Pills (www.worstpills.org) is a reputable, subscription-based project of the advocacy group Public Citizen that tracks safety information on nearly 2,000 drugs.

Why does the FDA permit biased company trials for safety and efficacy? Perhaps it has something to do with Congress’ underfunding of the FDA since the antiregulation period under President Ronald Reagan and then having companies fund the division that evaluates their drugs.

These practices subject patients to a double conflict of interest. First, companies test their own drugs for the public regulator, rather than having them tested independently. Then, companies pay the FDA a huge fee – $2.3 million in 2015 – to review each drug. Highly trained and skilled staff work hard to do thorough reviews. But the reviews are on the companies’ terms – their criteria, their trials, their data, their deadlines, their funded patient groups clamoring for approval, and their money.

Reviewers do turn back or turn down drug candidates. Yet 90 percent of the drugs the FDA approves are judged by independent reviewers to provide few or no clinical advantages for patients over existing drugs.

And because these new drugs are inadequately tested, the results are predictable. One in every five new drugs ends up causing enough serious harm to lead the FDA to add the most serious black box warning, or remove the drug from the market – after the harm has been done.

This risk increases to one in three when reviews are accelerated under a special (and legal) process, requiring even higher fees from drugmakers.

Do patients really want faster access to drugs that provide few or no new benefits and have substantial risks of serious harm? Do they want an FDA that largely serves the industry that funds it by approving many new minor variations to increase sales, without good testing for safety?

A few clinically superior drugs are developed each year. But accelerated reviews and low, loose FDA criteria encourage companies to develop more minor variations that will get through the approval process, rather than focus on major advances. To encourage more superior drugs, the FDA needs to require tests for real clinical advances compared to risks of harm.

We need a congressional investigation, with subpoena power, to investigate how the FDA allows manipulations of true randomized trials that understate risks of harm. We need to end a third conflict of interest that endangers patients: The same FDA group that approves drugs as “safe” is responsible for investigating evidence of harm. Only 10 percent of FDA staff are assigned to drug safety. We need an independent, well-funded watchdog for patient safety.

Most important, as a public agency charged with protecting people from unsafe drugs, the FDA needs to be funded entirely by taxpayers. Drugs are now the fourth leading cause of death in America, tied with stroke. The FDA needs to stop contributing to this problem and help reduce the number of patients exposed to risks of serious harm.

Donald Light is a widely published expert on drug policy and a professor of comparative health policy at Rowan University

ACLU sues because of FOIA refusal..but. on ADA violation… MIA ?

ACLU takes Drug Enforcement Administration to court

At issue is a Providence man’s request to open records in ‘pill mill’ case

http://www.providencejournal.com/article/20151225/NEWS/151229517

    PROVIDENCE, R.I. — What began as a graduate school thesis project has led freelance journalist Phil Eil on a years-long quest for documents that has spiraled into a legal battle with the U.S. Drug Enforcement Administration over access to records.

    In a lawsuit brought by the American Civil Liberties Union in federal court in Rhode Island, Eil is seeking evidence presented to the jury in the 2011 trial of Paul Volkman, an Ohio doctor serving four life sentences for his role in operating a pain management clinic like a “pill mill,” leading to patients’ deaths. Eil is asking U.S. District Court Judge John J. McConnell Jr. to order the records released and to find they were wrongfully withheld by the DEA.

    “There is great public interest in seeing where the line is drawn between medicine and drug dealing,” said Eil, 30, of Providence, a former news editor of the defunct Providence Phoenix and an adjunct writing professor at the Rhode Island School of Design.

    The DEA, which investigated Volkman’s case, is refusing to release some of the records and heavily redacting others. They argue that witnesses’s private medical information is at stake and that disclosure of such information is not required or permitted under federal law. The federal government is asking that Eil’s complaint be dismissed. U.S. Attorney Peter Neronha’s office is representing the DEA and declined comment through a spokesman.

    “A significant portion of these exhibits consists of patient medical records and other similar materials containing highly personal information about Volkman’s victims,” Assistant U.S. Attorney Richard B. Myrus wrote in court documents. The records are exempt from disclosure because they fall into two exempted categories: medical or law enforcement records.

    “The limited disclosure of this information at trial did not extinguish the privacy rights of the third parties involved, i.e. Volkman’s patients, and release of these records now would constitute an impermissible invasion of their personal privacy, which would expose their medical histories.”

    Eil said he became intrigued with Volkman’s case in 2009 when Volkman asked Eil’s parents — after years without contact — to attend his wife’s funeral. Eil’s father and Volkman had attended the University of Rochester as undergraduates and went on to the same federally funded medical and doctorate program at the University of Chicago. A classmate had Googled Volkman and learned he had been indicted in 2007 on 22 counts, including prescribing painkillers that authorities said led to the death of at least four people.

    At the time, Eil had just enrolled in a nonfiction master’s program at the Columbia University School of the Arts and thought that the Volkman story could be his thesis project. He reached out to Volkman, who he said was convinced he was performing his medical duties in prescribing the drugs.

    “He believes he’s in prison for practicing medicine,” Eil said in a recent interview. Eil soon thought he had the makings of a book.

We are from the government and are here to help you ?

DEA INFLICTS HARM ON CHRONIC PAIN PATIENTS

http://canceravoidmid.com/dea-inflicts-harm-on-chronic-pain-patients/

In an effort to curb opioid drug abuse and addiction, the Drug Enforcement Administration (DEA) has issued new rules that limit the accessibility of hydrocodone, putting chronic pain sufferers who rely on the drug in an impossible situation.

The DEA’s new restrictions come after the decision to relabel hydrocodone as a Schedule II drug, making it difficult for users with chronic pain to receive the medicine they need. The recent changes include the elimination of phone-in refills and a mandatory check-in with a doctor every 90 days for a refill.

HCPs

Hydrocodone is one of the most widely used drugs to fight chronic pain in the United States, serving a consumer base of about 100 million people. Many who rely on hydrocodone suffer from debilitating chronic pain, which greatly disrupts and decreases their quality of life.

Pain advocates across the country were vocal when the DEA announced these changes: they would have unintended consequences that would hurt, rather than help, legitimate pain patients in need. I spoke with a former patient of mine to find out how she was affected by the up-schedule of hydrocodone. She lives two hours away from the doctor who currently helps manage her pain. For her, it’s a 4 hour round trip every 90-days to access the medication that has helped revive a semblance normalcy since her pain first surfaced when she was just 20 years old. What’s worse, she told me that now, more than ever, she has been made to feel like a criminal for seeking access to medicine that has been rightfully prescribed to her by her own doctor.

In attempting to decode how other patients have been affected by the DEA rule change, the National Fibromyalgia and Chronic Pain Association (NFMCPA) released a survey of assessing the first 100 days after the regulatory change. The results are scary:

·        88 percent of patients felt that the changes denied their rights to access pain medication

·        71 percent report being switched to less effective medications by their doctors, who are fearful of legal issues

·        52 percent felt an increase sense of stigma as a patient receiving hydrocodone

·        27 percent of patients even reported suicidal thoughts when unable to access their prescription.

Controlling the abuse and overuse of pain killing drugs is necessary to keep patients safe, but the importance of decreasing drug abuse does not outweigh the needs of millions of people who suffer from chronic and depleting pain. When patients who suffer from these excruciating conditions are denied access to medication, they often turn to alternative forms of relief such as black market drugs, creating a larger issue of abuse.

Solving the problem begins with communication among the medical community, to ensure patients have access to their necessary medicine and the ability to live the life they deserve.

The medical system’s purpose is to treat and work for the betterment of patients. When we work against the people we are set up to serve, we are doing a great disservice to our cause and the people who rely on us most.

 

 

 

Update on a story where “following the rules” cost a pt their life

Death from diabetes sparks change, a new law

Original story:

When the CRACKS in the system are big enough to KILL PATIENTS !

AVON LAKE, Ohio — In February, Amy Houdeshell stood by her brother’s tombstone and explained why her brother, Kevin Houdeshell, a diabetic died at just 36 years old.

“He was young, fit, healthy. The pharmacy told him his script had expired and we’re sorry, but we can’t give you anymore. He tried three times to call his doctor’s office and, four days later, he passed away from not having his insulin.”

Fast-forward 10 months.

“I never imagined we would reach so many people with that one little story about my brother,” Houdeshell told WKYC Channel 3 News.

RELATED | Emergency insulin could have saved man’s life

On Tuesday, Ohio Governor John Kasich signed into law legislation that passed unanimously that essentially allows pharmacists to give up to a 30-day supply of even expired prescriptions of life-sustaining drugs.

“No one should have to die because of an expired prescription and can’t get hold of your doctor,” said Amy and Kevin’s parents, Dan and Judy Houdeshell.

The Houdeshell family has worked tirelessly to get this measure signed into law.

They got their wish this year, their second Christmas without Kevin.

Judy read from an old English class paper that Kevin wrote in high school.

“Live your life in the present like every day is your last. This is all about leaving your mark. To leave this world knowing we’ve made a difference, knowing that we will be remembered.”

Judy wiped tears away, looking up from the paper, saying, “…and so this would be what Kevin would have wanted.”

Diabetes Partnership of Cleveland

“Even though Kevin can’t come back, he’s made a mark in this world and he’ll save lives. His legacy,” said Dan Houdeshell.

The Houdeshells say other states, like Florida, Pennsylvania and New York, are following suit.

“We refer to it as Kevin’s Law. The Channel 3 story that you did with Amy in February really got the ball rolling,” said Dan.

“That was unbelievable. We couldn’t believe the response. It was totally overwhelming,” said Judy.

“It took losing my brother to save God knows how many other lives,” said Amy.

Now that HB 188 has been signed into law, it will take a few months before going into effect, and it will be subject to rules from the Ohio State Board of Pharmacy.

So you believe the driver’s license presented is valid ? Homeland security has doubts ?

http://www.foxnews.com/politics/2015/12/26/child-vaccine-mandate-minimum-wage-hikes-and-more-taking-effect-in-new-year.html?intcmp=hpbt2

Meanwhile, travelers from a number of states may soon have to bring their passports to the airport because their driver’s licenses will no longer serve as valid identification for U.S. airport security checkpoints. New “Real ID” laws requiring a uniform federal standard for driver’s licenses by the Department of Homeland Security are going into effect Jan. 1, and some states’ licenses are not up to those standards.

What could the new FL BOP rules mean for pts ?

64B16-27.831 Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education.

All rules/laws/regulations are subject to interpretation and this new standards for Pharmacists in Florida in regards to filling controlled substances is no different. Interpretations can be by the BOP, chain employers, individual Pharmacists… meaning that there still may be no cold/hard standard.

For the most part AG Bondi and the DEA are MIA as this new standard evolved

Keep in mind that Pharmacist are not required to have the new mandatory continued education until the later  part of 2017… so can the BOP just keep their hands folded until all the Pharmacists have been known to have completed this new requirement ?

Below is a copy of the new standards and I will be inserting my observation/opinion within the text.

https://youtu.be/WO4wcNVbYOQ
The Board of Pharmacy recognizes that it is important for the patients of the State of Florida to be able to fill valid prescriptions for controlled substances. In filling these prescriptions, the Board does not expect pharmacists to take any specific action beyond exercising sound professional judgment. Pharmacists should not fear disciplinary action from the Board or other regulatory or enforcement agencies for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice.

This was promulgated by the FL BOP and since Pharmacists are not licensed by the DEA.. They can’t promise that the Pharmacist’s employer could not be sanctioned/fined by another regulatory agency. Given the rapidly growing surplus of Pharmacist, generally being the cause of your employer getting fined.. will mean that you will get fired.

Every patient’s situation is unique and prescriptions for controlled substances shall be reviewed with each patient’s unique situation in mind. Pharmacists shall attempt to work with the patient and the prescriber to assist in determining the validity of the prescription.
(1) Definitions: For purposes of this rule the following definitions shall apply:
(a) Valid Prescription. A prescription is valid when it is based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.
(b) Invalid Prescription. A prescription is invalid if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.

For the Pharmacist to KNOW is presumed to be a FACT… a Pharmacist’s who’s belief that he/she KNOWS is based on the influence of personal phobias, biases or some other intangible reason ?  Who is going to go to bat for the pt, when a Pharmacist’s decision is based on the later and not the former ?
(c) Validating a Prescription. Validating a prescription means the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.
(2) General Standards for Validating a Prescription: Each prescription may require a different validation process and no singular process can fit each situation that may be presented to the pharmacist. There are circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance; however, a concern with the validity of a prescription does not mean the prescription shall not be filled. Rather, when a pharmacist is presented with a prescription for a controlled substance, the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his or her independent professional judgment.
(a) When validating a prescription, neither a person nor a licensee shall interfere with the exercise of the pharmacist’s independent professional judgment.

Does this mean that corporate policies like Walgreen’s “good faith policy” is to be rescinded or is not considered to be “interference “. If a Pharmacist states that they can’t fill a Rx because of company policy.. does that suggest that the Pharmacist’s independent professional judgement is being interfered with ?
(b) When validating a prescription, the pharmacist shall ensure that all communication with the patient is not overheard by others.

This appear to remind the Pharmacist that there is a Federal HIPAA regulation. Which was enacted TWENTY YEARS AGO ! Does this mean that if a Pharmacist does speak loud enough for other to hear that would permit the pt to file a complaint with the BOP for violation of this standard.  Another reason why pts should video all interaction with the Rx dept staff.

(c) When validating a prescription, if at any time the pharmacist determines that in his or her professional judgment, concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
(3) Minimum Standards Before Refusing to Fill a Prescription.
(a) Before a pharmacist can refuse to fill a prescription based solely upon a concern with the validity of the prescription, the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription by performing the following:
1. Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription;
2. Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(b) In lieu of either subparagraph 1. or 2., but not both, the pharmacist may elect to access the Prescription Drug Monitoring Program’s Database to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(c) In the event that a pharmacist is unable to comply with paragraph (a) due to a refusal to cooperate with the pharmacist, the minimum standards for refusing to fill a prescription shall not be required.

We may see the phrase “I’m not comfortable” .. with.. ” I don’t have the medication in stock..  Of course, Pharmacies are required to maintain a perpetual inventory of C-II meds.. If your Rx is declined you will need to note the date/time and it may take a court order to validate the presence of inventory at the time you were denied.  That leaves the question if the BOP will consider lying to pts unprofessional conduct ?
(4) Duty to Report: If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the Department of Health.
(5) Electronic Prescriptions: All controlled substances listed in Schedule II through V may be electronically prescribed pursuant to the provisions of Section 456.42(2), F.S. (2015), and pursuant to applicable federal law. For more information related to the federal requirements, access http://www.deadiversion.usdoj.gov/ecomm/index.html.
(6) Mandatory Continuing Education: All pharmacists shall complete a Board-approved 2-hour continuing education course on the Validation of Prescriptions for Controlled Substances. The course content shall include the following:
(a) Ensuring access to controlled substances for all patients with a valid prescription;
(b) Use of the Prescription Drug Monitoring Program’s Database;
(c) Assessment of prescriptions for appropriate therapeutic value;
(d) Detection of prescriptions not based on a legitimate medical purpose; and,

Is the BOP now instructing the Pharmacist to diagnose (second opinion)  the pt’s health issue, without the necessary training background, without doing a in person physical exam .. as any prescriber would be required to do before writing a prescription
(e) The laws and rules related to the prescribing and dispensing of controlled substances. All licensed pharmacists shall complete the required course during the biennium ending on September 30, 2017. A 2-hour course shall be taken every biennium thereafter. The course shall count towards the mandatory 30 hours of CE required for licensure renewal. All newly licensed pharmacists must complete the required course before the end of the first biennial renewal period.
(7) Summary Record: Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Section 893.07(4), F.S. Such summary shall include information from which it is possible to determine the volume and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substances being dispensed to a specific patient.
Rulemaking Authority 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS. Law Implemented 456.013, 456.42, 456.43, 465.0155, 465.003, 465.009, 465.016(1)(i), (s), 465.017, 465.022(12), 893.04 FS. History–New 8-29-02, Amended 2-24-03, 11-18-07, 12-24-15.

FL BOP makes new promises/rules… DEA .. MIA

New rules in effect for Florida pharmacists

Changes that went into effect on Christmas Eve could bring relief to thousands

http://www.wesh.com/news/new-rules-in-effect-for-florida-pharmacists/37125200

WINTER PARK, Fla. —A WESH 2 News investigation, 11 months in the making, is seeing results as the state of Florida tries to start fixing its prescription problems.

WESH 2 News first exposed the issue in January. Sick and dying men, women and children are being denied medication prescribed by their doctors, all because of a law meant to crack down on drug addicts.

The pharmacy rejections left patients to suffer, some spending their final days in crippling pain and others taking their own lives because of it.

Link: Standards of Practice for the Filling of Controlled Sustance Prescriptions; Electronic Prescribing; Mandatory Continuing Education

Thousands have shared their stories with WESH 2 News and state leaders have recognized the problem and are taking aim at it.

Changes that went into effect on Christmas Eve could bring relief to thousands of sick people.

Before cancer took Darlene Patsos’ life, she said pharmacists took her dignity.

“Who in their right mind would deny someone who has cancer?” Patsos said.

For nearly a year, WESH 2 News has investigated blanket rejections of patients at the pharmacy. Patients like Patsos with legitimate prescriptions were turned away for no reason.

“Maybe it removes a little bit of the fear,” said Gavin Meshad with the Florida Board of Pharmacy.

Special report: Pharmacies denying legitimate prescriptions

Florida’s Board of Pharmacy, after hearing from patients profiled by WESH 2 News, has pushed through a rule change for pharmacists, aimed at ending some of the difficulty patients are having.

Beginning Thursday, every pharmacist must take a mandatory two-hour training class every two years, going over ways to ensure legitimate patients get their medication.

For instance, before a pharmacist can reject a prescription, they are now required to first talk to the patient’s doctor to try to resolve any concerns. Pharmacists are urged to use a state database established to crack down on pharmacy shopping and abuse.

“I think this goes a long way in really clarifying what’s expected of the pharmacist,” Meshad said.

Winter Park pharmacist Linda Lazuka welcomes the new requirements.

WESH 2 News asked Lazuka if she thinks patients will see a difference.

“I do. It won’t be overnight. It’ll take a little time,” Lazuka said.

Lazuka, a board member with the Florida Pharmacy Association, thinks the rule will empower pharmacists and hopefully eliminate concerns many have expressed about being targeted by law enforcement and the Drug Enforcement Administration.

The fight for patients isn’t over. Next month, state Sen. Aaron Bean is expected to file a bill that’s also aimed at helping patients and pharmacists.

The bill, written after Bean watched the WESH 2 News investigation unfold, would eliminate the strict caps on the amount of medication pharmacists order from wholesalers.     

Special Section: State of Pain

The information provided has some pieces missing ?

Missing-Puzzle-PieceHealthcare.gov Signs Up 8.2 Million

Total is more than 20% higher than at same time in 2014

When Obamacare was first passed, it was stated that there was some 50 million uninsured people in the US.. and now we have 10 million less ??? No mention of the 40 million that would appear to still have no health insurance. Once again.. it isn’t what number they tell you.. it is the numbers that they don’t divulge. Our population is growing at about 10 million a year..  So they have 3 + million more people signing up while our population has grown by 10 million..  Is that like taking one step forward and THREE steps backwards ?

NEW YORK (Reuters) — The U.S. government signed up 8.2 million people for health insurance through the HealthCare.gov website, including 2.1 million people from the insurers’ most sought-after demographic — those ages under 35, the top health official said on Tuesday.

That compares with the 6.4 million people who signed up or were automatically enrolled at this time last year, U.S. Department of Health and Human Services Secretary Sylvia Burwell said during a conference call.

HealthCare.gov sells subsidized individual insurance in 37 states, and Burwell said millions more had gained coverage through the state-based insurance exchanges that serve Washington, D.C. and the remaining 13 states.

The enrollment figures come at a time when expectations for 2016 sign-ups have been tempered. The government has said it expects total enrollment of 10 million people via both HealthCare.gov and the state-based exchanges at the end of 2016, about half of what its 2016 estimate had been earlier this year.

Large health insurers have been lukewarm on the market, saying it is a challenge to make money there.

Health insurer UnitedHealth Group said last month that the low enrollment and high medical costs of those covered through the exchanges were causing the company to lose money. It said it would have to review its participation in the two dozen states where it sells plans next year.

The 8.2 million people signed up or automatically re-enrolled in a plan as of Dec. 19 will have coverage effective Jan. 1. Enrollment remains open through the end of January.

On Friday, the government announced that enrollment was running faster than last year and that 6 million people had signed up through Dec. 17, and shares of insurers rose.

Shares of Aetna, UnitedHealth, and Anthem all rose slightly on Tuesday after the government announced the most recent data.

The government said it estimated that more than 9.1 million people were enrolled for health coverage through HealthCare.gov and the state-based exchanges at the end of 2015.

Of the 9.3 million people who were enrolled at the end of September, about 84 percent received subsidies, the government said. The average subsidy was $271 per month. Enrollment fluctuates as people gain or lose employment-base insurance or have a change in status, such as becoming married.