Ensuring Patient Access and Effective Drug Enforcement Act of 2016
H.R.4095 – DEA Opioid Enforcement Restoration Act of 2017
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REPEAL: Ensuring Patient Access and Effective Drug Enforcement Act of 2016
Posted on October 24, 2017 by Pharmaciststeve
share your denial of care story
Posted on October 24, 2017 by Pharmaciststeve
Hello Everyone, I have been really busy spreading our plight on social media. I am now working with Jonelle Elgaway at CAW360 Conspiracies Against Wellness and we are interested n your stories. Please email them to stacy.f@conspiraciesagainstwellness.com and please include if we can contact you about interviewing on air with us! #WeR1 Gotcaw.com CONSPIRACIESAGAINSTWELLNESS.com
Thank You All,.. We MUST Keep Fighting!!
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Is this how employers lay the ground work to discharge employees treating chronic pain with opiates ?
Posted on October 23, 2017 by Pharmaciststeve
This is a recent memo from the TSA dept… it would appear by some who work for the TSA that they are laying the ground work for forcing employees off prescribed opiates and/or find reason to discharge employees who require opiates to treat their chronic pain.
Those chronic pain pts know that the taking of opiates typically do not affect their ability to perform most/all functions without compromise.
Of course, those who don’t have experience with taking opiates for chronic pain seem to refuse to listen/believe such
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Medicare/Medicaid: level of acceptable care for pts… depends on where treatment is provided ?
Posted on October 23, 2017 by Pharmaciststeve
Immediate jeopardy: True or false?
Probably no two words strike more fear in the hearts and minds of nursing home owners and operators than “immediate jeopardy.” And, for good reason. When immediate jeopardy is alleged by a survey team, a cascade of painful consequences is about to unfold.
When a survey team cites immediate jeopardy, it must notify the Centers for Medicare and Medicaid Services (CMS). The clock begins to tick: CMS will terminate a nursing home’s Medicare provider agreement within 23 calendar days if the immediate jeopardy is not removed.
Termination as a Medicare provider will lead to removal from the Medicaid program as well, and few nursing facilities can survive once that happens. In addition to possibly losing their business, nursing facilities cited with immediate jeopardy face huge civil money penalties (CMP), frequently exceeding $1 million.
Immediate Jeopardy
Federal regulations define immediate jeopardy as “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” (42 CFR 488.301). Thus, in order for immediate jeopardy to exist, there must have been noncompliance with a requirement of participation that either: 1) caused serious injury, harm or death to a resident, or 2) “is likely” to cause such harm.
The first part of the definition is usually simple to determine: Either a facility’s noncompliance, also called a “deficiency,” caused serious harm or death, or it did not. But the second prong of the definition, whether an alleged deficiency was “likely” to cause harm, often becomes a legal battle that is fought and resolved in the various stages of an appeal.
CMS publishes the State Operations Manual (SOM) as “guidance” to surveyors. The SOM helps surveyors interpret and understand the regulations, but it does not have the force of law. CMS has published Appendix Q of the SOM, Guidelines for Determining Immediate Jeopardy in order to help surveyors understand what constitutes immediate jeopardy.
Appendix Q notes that there are three components to immediate jeopardy: 1) harm – either actual or that which “is likely” to occur, 2) culpability, and 3) “immediacy.” Notably, Appendix Q informs surveyors that if serious harm or death has not already occurred, it is considered “likely” if it is likely to occur “in the very near future.” Appendix Q repeats the phrase “in the very near future” multiple times.
If something has not occurred for a year or say, seven months, is it really “likely to occur in the very near future”? CMS thinks so. In spite of its explicit guidance in Appendix Q, CMS has been known to argue that immediate jeopardy existed for many months even if there is no harm at any level during that period.
The problem for providers is that in such cases, CMS has often already imposed a CMP in excess of $1 million, which must be collected and placed in escrow. Unfortunately, an appeal can take years before a final decision is rendered.
Getting Justice
There is a silver lining for providers who wish to challenge immediate jeopardy determinations where CMS claims that immediate jeopardy existed for many months even in the complete absence of any harm or even a minor bruise to any resident.
In a recent case litigated by the author, CMS alleged that immediate jeopardy existed from September of 2012 to April of 2013. There was no harm to any resident during those seven months, and CMS did not allege that any resident was harmed from September to April.
Yet, CMS chose to demand a CMP of more than $700,000, to be paid by the provider years before the resolution of the case, which was then appealed. In 2017, when a final decision was rendered, the judge agreed that immediate jeopardy had existed, but only for several days—not seven months. The judge ordered CMS to repay the provider most of the CMP it had collected.
But, the story gets better. The Affordable Care Act contains a provision that requires CMS to repay any CMP it collected following a successful appeal by a provider—and pay interest on the amount held in escrow. In the case above, CMS had to repay the provider more than $600,000—with interest payments at the federal rate, totalling an additional $53,250!
In another current appeal filed by the author, the amount of the CMP is more than $4 million, compiled from three separate per-day CMPs. As noted above, where CMS escrows a CMP and a provider prevails at appeal, CMS would be required to return the escrowed money plus interest.
It depends on what the meaning of “is” is
Words matter. Since the federal regulation governing immediate jeopardy states that a provider’s noncompliance must have caused death or serious harm to a resident or that serious harm or death “is likely” to result from noncompliance, a closer examination of “is likely” may be helpful. Note that the regulation does not state that serious harm or death may be likely; it must be likely if immediate jeopardy exists. And, as noted above, the guidance CMS provides to surveyors defines the “immediacy” component as having to occur “in the very near future.” Immediate jeopardy should not be based on a theoretical or abstract level of harm that is not likely to occur in the very near future.
So, if no harm—let alone serious harm or death—has not occurred in many months or a year, is it really “likely” to occur? Common sense may suggest otherwise.
How likely is “likely”?
The Health and Human Services’ Departmental Appeals Board (DAB or Board) decides appeals of CMS enforcement actions. The DAB has defined “likely” in the context of immediate jeopardy as a word that is “ordinarily or commonly used to describe an outcome or result that is ‘probable’ or reasonably to be expected though ‘less than certain.’”
The DAB noted that Black’s Law Dictionary defines “likely” to mean “probable” which implies a greater degree of probability that a particular event will occur than do the terms “possible” or “potential.” According to the DAB, “probable” means that there is more evidence than not that an event will occur. On the other hand, “possible” is defined as “capable of existing” and “free to happen or not,” according to the DAB.
In explaining what “likely” means in the context of immediate jeopardy, and distinguishing between “probable” and “possible” the DAB stated that “In this regard, we have emphasized that a ‘mere risk’ of serious harm is not equivalent to a ‘likelihood’ of such harm.”
It is a well-established axiom of law that when the meaning of words is explicit and unambiguous, effect should be given to the plain meaning of words as expressed in a statute or regulation.
Providers face a significant legal obstacle according to the Administrative Law Judges who decide appeals of CMS enforcement actions. CMS’ determination of immediate jeopardy is “presumed correct.” The legal standard for a provider to successfully challenge allegations of immediate jeopardy is to demonstrate to the satisfaction of the judge that CMS’ determination was “clearly erroneous.” That places a high, but not insurmountable burden on providers.
In the past few years, CMS has increasingly taken the position that immediate jeopardy exists as of the date there was an alleged deficient practice and continuing through to the survey and beyond—even if the period is for many months—and there is an absence of harm or even the likelihood of harm. Recall that “likely” is synonymous with “probable” or “more likely than not” to occur. Gentle reader, if something has not happened day after day, for months on end, can it truly be said to be likely to happen? The answer lies in understanding the distinction between probable and possible.
Apart from the frequently enormous financial burden the penalties for immediate jeopardy place on a nursing facility, there are other adverse and negative consequences, not the least of which, is demoralizing the staff and upsetting residents. Providers would be encouraged if CMS considered the literal meaning of the word “likely” as used in the federal regulations. As noted above, the DAB has emphasized that, “a mere risk of serious harm is not equivalent to a ‘likelihood’ of such harm.” Thus, it logically follows that a “mere risk of serious harm” is not tantamount to immediate jeopardy.
The question often isn’t whether immediate jeopardy existed at all. That analysis is usually straightforward. The issue is whether, in the absence of serious harm for many months or even a year, can immediate jeopardy truly exist? If one strikes a match, a flame will immediately appear. However, if one rubs two sticks together, a flame may eventually appear or may never appear. Therein lies the difference between likely and possibly.
After the inception of this article and numerous complaints about the exorbitant amounts of per-day CMPs based on months of alleged immediate jeopardy, CMS modified its CMP policy. In a Survey and Certification Memo addressed to all State survey agency directors dated July 7, 2017, CMS stated that “per instance CMPs [are] the default for noncompliance that existed before the survey.”1 (The difference between a per-instance and a per-day CMP can be in the millions of dollars.) However, the same CMS Survey and Certification Memo also indicated that per day CMPs should be issued where immediate jeopardy “was cited with actual harm to a resident.”
- Revision of Civil Money Penalty (CMP) Policies and CMP Analytic Tool, Ref: S &C: 17-37-NH (July 7, 2017), available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-37.pdf
Some of the things that a nursing home provider can be found guilty of some level of “pt mistreatment” or ” lack of pt treatment” It would appear that the standard of care that these same pts receive in a out patient/home setting has a much higher bar to constitution pt abuse/mistreatment.
Why do we have a double-triple standard of care for ambulatory/home bound Medicare & Medicaid pts ?
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Labor Secretary Alexander Acosta said reducing opioid prescriptions was important to get unemployed Americans back into the workforce
Posted on October 23, 2017 by Pharmaciststeve
Insurers Promise More Cuts in Rx Opioids
By Pat Anson, Editor
Less than two weeks before its final report is due, President Trump’s opioid commission held its fourth and final public meeting Friday – hearing testimony from top government officials and insurance industry executives about the nation’s worsening overdose crisis.
“Insurance companies are going to be a very, very important part of whether we will be able to stem the tide here or whether we’re not,” said commission chairman Gov. Chris Christie of New Jersey.
It was clear from their testimony that many insurers are planning to tighten access to prescription opioids even more than they already have.
Aetna’s chief medical officer told the commission the insurance giant was planning to reduce “inappropriate opioid prescribing” to its members by 50 percent within the next five years. He did not explain what would be considered inappropriate.
Aetna has already sent warning letters to hundreds of physicians and dentists identified as “super-prescribers,” urging them to reduce the number of opioid prescriptions they write.
“We’re now re-running our analysis and planning more aggressive interventions for those providers who haven’t improved their opioid prescribing habits over the past several months,” said Harold Paz, MD.
The chief medical officer of Cigna said his company was close to achieving a 25 percent reduction in coverage of opioid prescriptions, a priority it set last year.
“That’s only the first of our goals,” said Alan Muney, MD.
Insurer Harvard Pilgrim said its coverage of opioid prescriptions has declined by over 20 percent since 2014.
“That’s not enough. This feels like a balloon where you tap on one end and it comes out somewhere else. So it doesn’t mean we’re even close to solving this,” said Michael Sherman, MD, chief medical officer of Harvard Pilgrim.
Insurers clearly have the ear of the federal government when it comes to opioids. As PNN has reported, an obscure federal advisory group composed of insurers, law enforcement, and federal and state regulators has discussed eliminating opioid prescriptions for acute pain, as well as paying doctors not to prescribe opioids.
The Healthcare Fraud Prevention Partnership also wants access to the “personally identifiable and protected health information” of 57 million Medicare beneficiaries to see if they are abusing opioids.
Reducing Opioids a ‘Win-Win’
Labor Secretary Alexander Acosta said reducing opioid prescriptions was important to get unemployed Americans back into the workforce. He cited a recent study that found that about a third of unemployed men aged 25 to 54 were using prescription painkillers.
“Reducing the amount of opioids is a win-win across the board. It’s a win for the individual who doesn’t want to get hooked,” Acosta said. “It’s a win for the insurance companies who don’t want to be paying for medicines that people don’t need. And it’s a win for the American workforce, because if we can get people back to work and paying taxes and participating fully, that’s a win for them and it’s a win for the country.”
Acosta cited no studies that might indicate how many Americans currently taking opioids would become unemployed or disabled if their pain medication was reduced or taken away.
No pain patients, patient advocates or experts in pain management were asked to appear before the commission. No one from the pain community has testified during any of the commission’s public meetings, although thousands have submitted written comments.
An interim report released by the opioid commission in July focused on expanding access to addiction treatment and developing new ways of treating pain without opioids. Since then, the commission has increasingly focused on limiting opioid prescriptions. The final report from the commission is expected November 1.
The interim report also strongly urged President Trump to declare a national emergency to speed up efforts to combat the overdose crisis, something he has yet to do. “We’re going to be doing it in the next week,” Trump told reporters on Monday. However, there appears to be little consensus in the administration about what actions to take after an emergency is declared or how to pay for them.
“Everyone wants opioids to be a priority, but there’s a lot of resistance to calling it an emergency,” a senior administration official told Politico.
We have what is INTENTIONALLY UNDER/UNTREATED chronic disease and the insurance companies are looking to reduce the amount of opiates that they pay for by up to 50%, and according to this article … the insurance companies are considering PAYING PRESCRIBERS to NOT PRESCRIBE OPIATES… basically – paying prescriber to DENY CARE to the very patients that are paying those same insurance companies premiums to pay for needed care.
“about a third of unemployed men aged 25 to 54 were using prescription painkillers.”
That above statement suggests that they are targeting men who are receiving monthly workman comp monies. There are no WOMEN in that age group that are taking opiates and unemployed. Has anyone seen this study they are referencing ?
They also want access to the HIPAA protected PERSONAL HEALTH INFORMATION… so if this happens.. would this suggest that there could be a MAJOR HIPAA VIOLATION by our government and the insurance companies.. Could the very fact that are given access would be UNCONSTITUTIONAL… ACLU where are you ?
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Special guest speaker on insurance October 25th at 9:00 PM EST!
Posted on October 23, 2017 by Pharmaciststeve
Special guest speaker on insurance October 25th at 9:00 PM EST!
https://livesupportgroup.com/join
Click on above link to register for the meeting, you will get a email with login instructions and special code
At Livesupportgroup.com, we strive to schedule speakers who are informative and timely. With Insurance time right around the corner, we are proud for the 2nd year, to have Melissa Harrelson to our group on Wednesday, Oct 25th at 9:00 EDT pm.
Last year Melissa covered our questions and the changes we faced.
Melissa is very knowledgeable about all types of Insurance. She will have time to share about the changes in Insurance for 2018. After the intro, we will have time for Q and A, so have your questions ready.
To be clear Melissa Harrelson is providing information as a community service.
Melissa Harrelson
Insurance Agent specializing in life and health insurance since 2005.
BS in Human Resources
SHRM-CP
Licensed in AR, MO, OK life and health insurance.
Licensed in AR Healthcare Marketplace and Arkansas Works.
To attend there is no cost to members. Please go to the join tab, fill in your email, your first name, last initial, and state. Confirm your membership in your email. Then an email saying it is time to register for the meeting will come to your email. When you get your email to attend the event, fill in the information and a personalized link will come. One hour before the group you will get a reminder and a duplicate link for your convenience.
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Indiana: needle exchange program.. 50 percent decrease in hepatitis C cases… CANCELLED .. BIBLE MADE THEM DO IT
Posted on October 22, 2017 by Pharmaciststeve
An Indiana county just halted a lifesaving needle exchange program, citing the Bible
https://www.vox.com/policy-and-politics/2017/10/20/16507902/indiana-lawrence-county-needle-exchange
“People will absolutely die as a result.”
That’s how Chris Abert of the Indiana Recovery Alliance described the consequences of an Indiana county’s decision to stop a needle exchange program, which provides clean syringes to drug users in an effort to stop the spread of infectious blood-borne diseases like HIV and hepatitis.
Lawrence County commissioners’ reasoning: morals — and the Bible.
“It was a moral issue with me. I had severe reservations that were going to keep me from approving that motion,” County Commissioner Rodney Fish, who voted against the program, told NBC News. “I did not approach this decision lightly. I gave it a great deal of thought and prayer. My conclusion was that I could not support this program and be true to my principles and my beliefs.”
Before he cast his vote, Fish quoted the Bible — specifically, 2 Chronicles 7. It says, “If I shut up heaven that there be no rain, or if I command the locusts to devour the land, or if I send pestilence among my people; if my people, which are called by my name, shall humble themselves, and pray, and seek my face, and turn from their wicked ways; then will I hear from heaven, and will forgive their sin, and will heal their land.”
The empirical evidence, however, is on the needle exchange programs’ side. Abert said that it’s led to a 50 percent decrease in hepatitis C cases in Lawrence County so far this year. And multiple reviews of the evidence by the World Health Organization, the Centers for Disease Control and Prevention (CDC), and others have overwhelmingly supported needle exchanges.
Abert also argued that, if anything, the Bible teaches people to help those in need — exactly what a needle exchange program aims to do. “Christians believe their spiritual life is defined by how well they mirror Christ’s work in their daily lives,” he told me.
But that didn’t persuade commissioners, and they voted against the program.
Indiana’s troubled history with needle exchanges
This isn’t the first time needle exchange programs have proven controversial in Indiana.
In 2015, the southeastern part of the state suffered an HIV epidemic linked to the injection use of Opana, a prescription painkiller that’s been widely misused throughout the opioid crisis. Back then, state lawmakers — including then-Gov. Mike Pence — were opposed to a needle exchange program. It was only after the HIV epidemic worsened that Pence finally relented, allowing a needle exchange program in Scott County and later signing a law that lets counties set up needle exchange programs if they prove they have an epidemic.
But some counties have been resistant to the concept. NBC News reported that earlier this year, Madison County also shut down a needle exchange program due to pressure from the local prosecutor and Indiana Attorney General Curtis Hill, who was elected in November and opposes needle exchange programs.
Lawrence County was among the several that got permission for a needle exchange program. But this month, the program was halted pending reapproval from county commissioners. The law requires county approval for the program on an annual basis, even though the needle exchange does not use county or state funding.
On Tuesday, county commissioners voted against the needle exchange program. They heard from some members of the community who were opposed to the program, but Abert said that a drug court judge, academics, and health care providers also testified in favor of it. Ultimately, the commissioners sided with the opposition.
“It came down to morally, they’re breaking the law. I can’t condone that,” County Commissioner Dustin Gabhart said, according to Indiana Public Media. “Yes, it’s a problem. Yes, it needs to be resolved. I could not give them the tools to do it.”
Needle exchanges save lives. Period.
The common argument against needle exchange programs, echoed by Indiana officials, is that they enable drug use by providing people with the tools to use drugs. And, they claim, that may lead to more drug use.
The claims are not borne out by the evidence. A 1998 study from researchers at Johns Hopkins University found needle exchange programs generally reduced the spread of HIV without increasing drug use. A 2004 study from the World Health Organization, which analyzed two decades of evidence, produced similar results. A 2016 review of 15 studies by the CDC did as well.
As one example, the CDC noted that once Washington, DC, was able to implement a needle exchange program, an evaluation “showed a 70 percent decrease in new HIV cases among [injection drug use] and a total of 120 HIV cases averted in two years.”
This is, frankly, not a remotely controversial topic in the research: Needle exchange programs save lives. Many people are going to find ways to use drugs no matter what, and providing them with clean syringes at least eliminates some of the risk tied to that drug use.
Experts also say needle exchange sites can be crucial for linking people to addiction treatment. For an upcoming story, John Brooklyn, an addiction doctor in Vermont, told me that these programs can be critical for “meeting people where they are.” The idea is simple: Addiction treatment staff can drop by these needle exchange programs and offer their services. People won’t always take up the suggestion, but it helps reinforce that treatment is around and available.
Indiana’s story, though, shows the one thing holding back these successful public health programs: stigma that treats addiction as a moral failure instead of a medical issue.
So despite the public health evidence, officials will often cite moral objections to needle exchange programs. And more people will die as a result.
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CVS Health Larry Merlo Works Magic By Taking Over The Drug Enforcement Agency
Posted on October 22, 2017 by Pharmaciststeve
CVS Health Larry Merlo Works Magic By Taking Over The Drug Enforcement Agency”
Merlo pulls another rabbit out of his hat
Washington DC – CVS Health Executive Director, Larry Merlo and his cast of greedy shareholders and slick attorneys deal the United States Government another major blow in their efforts to combat crime. Special interest groups are organized groups of individuals sharing common objectives who actively attempt to influence policy makers. Corporations now spend about $2.6 billion a year on reported lobbying expenditures—more than the $2 billion we spend to fund the House ($1.18 billion) and Senate ($860 million). It’s a gap that has been widening since corporate lobbying began to regularly exceed the combined House-Senate budget in the early 2000s.
Today, the biggest companies have upwards of 100 lobbyists representing them, allowing them to be everywhere, all the time. For every dollar spent on lobbying by labor unions and public-interest groups together, large corporations and their associations now spend billions of dollars. Of the 100 organizations that spend the most on lobbying, 95 consistently represent business. Lobbying is nothing new to the U.S. Government and we have seen how special interest groups shape laws and trigger regulations for institutions like the Food and Drug Association (FDA) and we have seen how Big Pharma lobbied hundreds of health care bills in recent history, including the infamous Obamacare.
Larry Merlo of CVS Health and his train of corporate business lawyers has pulled-off the unthinkable, the biggest trick of all – They bought off the U.S. Government policing agencies designed to uphold the laws of the United States of America. This was a brilliant plan and most authorities consider this to be, one of the biggest tricks of the 21st Century. Everybody is talking about how Larry Merlo’s special interest group infiltrated the DEA, a Government entity funded by U.S. Tax dollars, and buy off 52 of their top lawyers and access thousands of DEA confidential records, including top secret investigative and active investigate files.
Larry Merlo and many corporate leaders feared for their safety as the lucrative DEA closed in on their dubious practices, which were designed and engineered to cripple the American public by introducing pharmaceuticals that they knew would cause harm. Big Pharma is not only controlling the DEA with U.S. tax dollars backing them and their agenda, they are also in control of the United States Congress – a public statement made by Senator Bernie Sanders. CVS passed Legislation to strip the DEA’s power to arrest corrupt Big Pharma executives passed with flying colors through the ranks of the Senate and Congress, surprisingly, without any objections by U.S. Government. The law to protect Big Pharma from prosecution should be repealed because corporate executives who bribed and paid-off government officials to provide protection for their own illegal crimes is not constitutional.
How Can You Make A Difference?
- BECOME A MEMBER: Please support Doctors of Courage and our fight against unlawful Government abuse of doctors and healthcare providers nationwide. Your Membership helps to provide support for thousands of doctors who are being unlawfully jailed and stripped of their medical careers for treating patients with legal prescriptions.
- JOIN THE FIGHT:Please support the American Pain Institute (API) at http://www.americanpaininstitute.org and get involve with their PAIN ADVOCACY WEEK, April 23rd – 30th, 2018, March On Washington and donate to help this cause. Thousands of Chronic Sickle Cell patients’ lives are being drastically reduced and they are dying because doctors are afraid to follow NIH treatment guidelines due to bigotry and government wrongful persecution of doctors in this country.
- HELP MAKE CHANGE: Sign our petition requesting that Congress enact a Medical Board Civilian Police Review Committee law to deter medical board police and prosecutorial misconduct and hold these officials responsible for their actions. The most common crime against doctors made by the medical board police teams are “FALSE REPORTS” that police officers refer to as accusations. These are criminal actions by law enforcement and they are not held accountable for making false statements, perjury, and manufacturing evidence. A Civilian Police Review Committeewill help stop these senseless acts against healthcare providers and restore justice and constitutional rights.
SIGN / SHARE OUR PETITION to fight for doctors and nurses rights:
CLICK NOW – (: SAY NO TO DEA/MEDICAL BOARD POLICE
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community pharmacists said they were serving patients with legitimate pain
Posted on October 22, 2017 by Pharmaciststeve
DEA Chief: Pharma-Backed Law Hasn’t Hurt Agency’s Fight Against Opioids
The then-chief of the Drug Enforcement Administration assured Democratic Rep. Judy Chu the bill she cosponsored to take away a tool the agency used to prevent opioids from reaching the streets wouldn’t hinder the agency’s work.
A Washington Post and “60 Minutes” investigation revealed drug companies dumped millions into lobbying for the bill, the Ensuring Patient Access and Effective Drug Enforcement Act, which essentially stripped the DEA’s ability to suspend pharmaceutical companies that sent suspiciously large opioid shipments.
Chu of California received more than $31,000 from the pharmaceutical industry as of last year, according to the Center for Responsive Politics, but she told The Daily Caller News Foundation she was assured — in a meeting that took place five months after the law passed — the bill wouldn’t hurt the DEA’s work. (RELATED: Pharma Association Defends Law Weakening DEA’s Opioid Enforcement)
“I met with Chuck Rosenberg, the then-acting head of the DEA, who insisted that the bill would not negatively impact their work,” Chu told TheDCNF in a statement. “[I]t was my understanding that the DEA was closely involved in advising on drafting language that would not impact their mission,” she added. “I did not receive indication of opposition or concerns from within the DEA.”
Rosenberg also said “the legislation was unnecessary,” Chu recently wrote in a letter to the House committees on Energy and Commerce and Oversight and Government reform, while requesting an investigation on the law impacted the DEA’s ability to combat the opioid crisis.
The DEA and the Department of Justice publicly opposed the original version of the legislation introduced in 2014. Agency officials didn’t object to the final version, but felt they were forced to accept a compromise on a bill that would ultimately pass, according to the Post/60 Minutes investigation.
“DEA felt this wasn’t a great solution, but was the best of the options offered to us, even if it did not fully address the concerns we had previously laid out for you,” Justice Department congressional liaison Jill Wade Tyson wrote in an email obtained by the WaPo/60 Minutes investigation.
The bill has created new challenges for the DEA, but investigators have started using new tools and haven’t “slowed down” the current acting-agency chief, Robert Patterson, recently said.
Chu also supported the bill to encourage the DEA to set better guidance for drug distributors to balance between ensuring patients can get their opioid prescriptions filled while preventing the painkillers from reaching the streets.
“I spoke with community pharmacists who said they were serving patients with legitimate pain, but were getting blocked with no explanation,” Chu said in her statement. “Their request was to receive consistent guidance from the DEA so they could avoid disruption for legitimate patients.”
“Community pharmacists must balance the work of combatting abuse with the work of ensuring those who need treatment have access to the medicine that can help,” she continued. “But after speaking with them, it was clear they needed better guidance in order to ensure they did both jobs appropriately.”
Lawmakers passed the bill unanimously, Chu noted.
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New Jersey: CDC guidelines causing more under treatment of pain ?
Posted on October 22, 2017 by Pharmaciststeve
Pain predicament: Opioid epidemic impacts prescription drug users with chronic pain
BURLINGTON TOWNSHIP — James Stewart remembers putting on his pads and running onto the grassy field to play football. The township resident said it was just over 20 years ago when he and his friends would still play competitively, despite being well into their 30s and 40s. Stewart has had a deep love for the game since childhood, and it’s stayed with him as he played in high school, college and then for fun.
But shortly after Stewart stopped playing, he began to have pain, mainly in his back, but also in his knees and other joints. He eventually underwent a two-part back surgery, as well as seven other surgeries in different areas to repair both bone and ligament damage.
“Most of the surgeries weren’t real heavy-duty stuff,” he said. “When I got to the back, it was a difficult surgery.”
Stewart, now 64, was sent home with two types of opioid painkillers in 2008 after the surgery to help deal with the pain. He had been warned about their addictive nature and took only one of them — 30 milligrams of oxycodone, as prescribed — to be able to move around without suffering.
“It was a two-part surgery, and I have chronic pain. It’s nerve on nerve. And I also need neck surgery. So I’m on medication just to try to have a decent day,” he said. “I’m not taking them to party. I don’t feel any ‘highness.’ All I feel is relief that I can go about a little bit of the day for a little while until it wears off.”
Stewart is one of at least 100 million Americans who suffer from chronic pain, according to a 2011 report from the Institute of Medicine. His original prescription said he could take one 30 mg pill four to six times a day, depending on his pain levels.
“I think I have a very good doctor, who did the best he could on my back, and I had to come in every time to get a prescription. There was no funny business,” he said. “I had to come in to see him personally to get a prescription. I never missed an appointment.”
However, just a few months ago in late April, Stewart said things changed. Instead of going to his doctor, he now goes to a pain management center to get his prescription filled, and his dosage amount was also reduced.
“(The pain management center) gave me a prescription for the 30 (mgs), and then when I came back the second time, I was informed, not asked, not, ‘How do you feel about this? What do you think about this?’ — I was told that now you’d be cut down to 15 mg, and that’s all I was told,” he said. “I was given a piece of paper that had this new guideline from the CDC.”
New guidelines
According to a statement from the U.S. Centers for Disease Control and Prevention, “Chronic pain is common, multidimensional and individualized, and treatment can be challenging for health care providers as well as patients.” In response to the critical need for consistent and current opioid prescribing guidelines, the CDC released the “Guideline for Prescribing Opioids for Chronic Pain.”
The purpose of the guidelines is to curb the overprescribing of opioid medication that led to the opioid epidemic, according to a statement from the CDC.
“Improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment, while reducing the risk of opioid use disorder, overdose and death,” the statement said. “Nearly 2 million Americans, aged 12 or older, either abused or were dependent on prescription opioids in 2014.”
In Burlington County, over 90 people have died from an overdose from January to July this year. Nationwide, more than 64,000 people died of an overdose in 2016, according to data from the CDC.
The guidelines focus on three main points: Determining when to initiate or continue opioids for chronic pain; monitoring the opioid selection, dosage, duration, follow-up and potential discontinuation; and assessing the risk and addressing the harms of opioid use.
Dr. Benjamin Duckles, a pain and spine specialist with Virtua who treats many chronic pain patients, said that since the new guidelines came out, he requires that all previous prescription histories and medical records are handed over to him so he can determine the best course of treatment for his patients.
“It depends on what treatment they’ve had prior to seeing me,” Duckles said. “The first and most important notion is to establish a diagnosis so we can discuss the history of their pain experience. I’m a big proponent of involving the patients in the process of understanding their pain or diagnosis.”
One of the new additions to the guidelines is that dosage recommendations for “exercising caution are lower than previous opioid prescribing guidelines.”
That was one of the issues Stewart had with the new restrictions.
“So the 30 (mgs), I could take no later than 8:30-9 in the morning, and that could last me, if i was lucky, until 2 (p.m.),” he said. “Then I would take another one about 3-4 (p.m.), and I was good. Now I take a 15 (mg), I don’t feel anything. I’m still bent over in the morning. They’re just not as effective as the 30 (mgs).”
Stewart said the reduction in dosage has dramatically affected his ability to get around like he used to.
“I’m just a little upset. I just want (my relief) back. I don’t do a whole lot. I’m not very active anymore; I can’t be,” he said.
Unintended consequences
In June, the American Academy of Pain Medicine released a “Future of Pain Care” resolution, noting that while the steps taken to address the opioid epidemic were helpful in many ways, they also adversely affected some patients who had used opioids safely and effectively.
“While the Centers for Disease Control drafted the Guideline for Prescribing Opioids for Chronic Pain to address the dramatic rise in opioid-related deaths, the document has, in some cases, had the unintended consequence of encouraging under-treatment, marginalization and stigmatization of the patients with chronic pain,” the resolution said.
Cassandra Badie, a Camden County resident, said she has felt this stigmatization as someone who suffers from neuropathy, stemming from her diabetes, which causes nerve damage in her feet and legs.
“You just don’t know what the feeling is to be treated like a drug dealer,” Badie said.
Some health officials caution that with all the focus on the opioid epidemic, other areas of the health care system are being ignored.
“All of the oxygen in the room is being used to address opioid addiction but not one of the primary causes, which is inadequate pain treatment,” Dr. Robert E. Wailes, a delegate with the American Academy of Pain Medicine, said in a statement attached to the resolution.
Duckles said he recognizes that opioids can be part of an effective treatment strategy for patients.
“One of the more important things we need to discuss is not forgetting that there are a lot of patients who have used opioids on a chronic basis for a long time and have done well,” he said. “Their pain has improved, and they’re able to do the things that they enjoy, whether that’s work or pleasure.”
Still, he cautioned against solely using opioid pills to treat pain. While each patient’s treatment is individualized, Duckles said he also employs other techniques, such as the use of anti-inflammatory prescriptions and physical therapy.
“My training taught me that the use of opioid therapy should never be done in isolation,” he said. “Opioid therapy alone doesn’t give them the best outcome.”
Patients like Stewart, however, said they at least would like to be included in the discussions that could have drastic effects on their lives.
“I’m not trying to cause a stink for anyone. I just want my medication not to be messed with and just to be talked to about it,” he said. “I’m not here to play any games. All I want to do is just have decent days.”
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