PAINKILLER LAW: Old Habits Die Hard, but Die They Must

The unmistakeable, tectonic shift in the medical establishment’s thinking about opioid prescribing continues to reverberate across the country. The medical community and law enforcement are starting to be of one mind, with the CDC‘s recent game-changer of a statement that too many doctors prescribe too many opioids to too many patients for too many things. As I have been writing, medical providers and insurance carriers and risk managers and medical malpractice lawyers need to change with the changing science, or get run over by the oncoming train of opioid-prescribing reform. Today’s post is a case in point of who could get pulverized.

NPR has reported that according to recent studies, many primary care doctors prescribe opioids for back pain when the accepted normal beginning course of treatment should be ibuprofen and physical therapy. The studies cite a number of possible reasons for tossing aside other treatments in favor of narcotics: Economics, insurance-reimbursement pressures facing doctors, online ratings by patients and the need to keep patients happy (or face online criticism and fewer referrals), and other factors. The studies note that with 1 in 10 primary care visits scheduled because of patient back pain, that’s a lot of opioids being prescribed when they shouldn’t be.

Medical providers who even a few months ago would have treated with opioids now need to wake up and smell the coffee, Mrs. Bueller. It’s no longer sufficient justification in light of the CDC’s new position on opioid prescription rates. As it is written:

“You want to be able to say, ‘When the science changed, so did I.’”

I wrote that two posts ago; I just wanted you to think I was quoting Scripture. I will continue to urge providers and the professionals who support and defend them to immediately and thoroughly evaluate all aspects of their opioid prescribing, in light of the CDC’s new position – which has since been cited favorably by the AMA. Any professional association, medical society or advocacy group that tells you times haven’t changed is not keeping up with current events, and may as well be directing you to stand on the train track and not move, no matter what. Stay up to speed, seek help in evaluating your practice or the advice you give your insureds or clients, and modify accordingly — today.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: When Crime’s All You Look For, You See Too Many Criminals

If you wake up every morning, strap on a badge and gun and go fight the War on Drugs, you come to view the world in a certain way. If your goal for each workday is to go in peace and not come back in pieces, your perspective on society, people, crime and your role in combating evil are invariably shaped by your experience. That’s why it’s a mistake for the DEA to bring its ordinary approach against drug crime to the issue of prescription drug abuse. But that is just what the agency is doing. It is basically treating like a criminal any healthcare professional who shows up on its radar.

At the recent joint conference sponsored by the California Medical Board and Board of Pharmacy, I heard the DEA speak about rampant drug diversion, pharmacists’ widespread complicity in prescription drug abuse, doctors wantonly prescribing outside the standard of care, drug dealers in white coats, and the DEA’s determination to crack down. The problem is, no one can quantify the degree of “complicity” by the nation’s pharmacists, or durably judge when a provider is prescribing outside the standard of care. The DEA says it’s happening, and its agents are the ones with the guns, and so, well, it must be happening.

The sense of things that I had coming into the conference was unfortunately not at all changed by what I heard there. The DEA’s talk was dominated by war stories of pharmaceutical distributors selling Oxy out the back door, of pharmacists ordering more than they need and keeping lousy records of where it all went, of doctors making megabucks writing scrips for no reason, and patients visiting websites devoted to the celebration of hallucinogens. Seriously, that’s what the speaker talked about. That’s clearly not the entire scope of the issue, and those characterizations don’t fairly define all medical providers or pharmacists or patients. None the less, the DEA is bringing its habitual mindset to a new class of cases and investigations – and a new “target” population – and that’s the wrong approach.

Clearly, the DEA is in reaction mode, just as Medical Boards nationwide are, and it’s being blamed for missing the early signs of what became a prescription drug abuse crisis. In reaction to the blame, the DEA is redirecting the pressure onto doctors, pharmacists and others who the DEA thinks are responsible for whatever the agency is supposed to be trying to stop. And what exactly is to be stopped? Who should decide whether a patient needs the drugs he or she is given: The prescriber, or the federal agent? If a doctor prescribes a lot of pills to a lot of patients, does it mean he or she is operating a pill mill? If a pharmacist fills prescriptions, is the pharmacist automatically part of the problem? And if the meaning of “outside the standard of care” can’t even be succinctly articulated in the law, how are law enforcement agents to know where the line is, BEFORE they decide a practitioner or pharmacist is dirty?

These are the questions all of us must vigilantly continue asking, persistently and if need be peskily, in this latest iteration of the War on Drugs. There is no easy answer, no matter what the DEA might think.

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VOICE OF REASON VS. CALL TO ARMS: THE CALIF. MEDICAL/PHARMACY BOARDS’ CONFERENCE ON PRESCRIPTION DRUG ABUSE

Recently I attended a conference sponsored by the California Medical Board and Board of Pharmacy. I think I was the only criminal defense lawyer in the room. The two-day event was entitled, “Joint Forum to Promote Appropriate Prescribing and Dispensing,” and was supposed to help healthcare providers and pharmacists know the law of controlled substance prescriptions, so they could follow the law and care for patients better. But that didn’t happen. Instead, during a Q and A with high-ranking Board officials on a panel, one attendee put it perfectly: The Boards are in “punitive” mode, “waiting to pounce” on prescribers and providers. That really was the unmistakable and highly regrettable message of the conference. In this post and several to follow, I’ll explain.

The voice of reason was heard briefly in the conference’s opening session. It belonged to the White House Office of National Drug Control Policy, better known as the Drug Czar. The speaker from the Office listed ways to screen for potential abuse, advice for effective patient monitoring, relevant CME, and other tools doctors could use in caring for patients while helping to curb abuse.

The speaker’s final suggestion was the most interesting, to me: He advised providers to regularly prescribe naloxone, the “anti-overdose” drug that has helped save the lives of accidental opiate overdose patients around the country. Great idea! But there’s also a downside, which I pointed out to the speaker: In today’s aggressive enforcement environment, the DEA and Medical Board might view writing for naloxone as prima facie evidence of excessive opioid prescribing. After all, if a doctor felt a patient was at risk of overdosing, why did the doctor write the opioid scrip at all? And why did a pharmacist fill it? What I fear, and what the official acknowledged could be a real issue, is that a provider’s or pharmacist’s act of patient protection could be used against them in a federal or state criminal investigation. That, to put it technically, would be totally uncool. And unfair. And inadvisable as policy and practice.

When the Drug Czar’s office had concluded its remarks, the DEA assumed the microphone. With that transition, the voice of reason gave way to a one-sided call to arms against the very professions represented by the conference’s attendees. More on this in the next post.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: FDA and I Call For Abuse-Deterrent Drug Agents

The FDA today called upon pharmaceutical researchers to develop formulations of opioids that would bring pain relief while reducing the possibility of addiction. The FDA refers to “abuse-deterrent” drug agents in the chemical sense. I join the FDA in calling for abuse-deterrent drug agents, only the kind of agents I’m talking about wear badges, drive fast in unmarked cars, and show up heavily armed.

The FDA should be commended for its balanced approach, in which it seeks both the development of less addictive drugs, and the need to get real pain relief to patients. What concerns me is that in investigating healthcare providers who write Schedule II-V prescriptions, typically law enforcement agents including the DEA and state Medical Boards emphasize “case clearing” over balance, hard and fast over nuance, and black and white over shades of gray. Whereas the FDA’s January 9 statement expresses its extreme concern “about the inappropriate use of prescription opioids,” the FDA doesn’t define “inappropriate.” Left to the determination of the DEA, which has been accused of being late to the party on addressing prescription drug abuse, and left to state Medical Boards, which have been accused of bailing on the party altogether, the definition of “inappropriate” could be bent, twisted, contorted, and most dangerously, broadened to encompass practices and procedures which a better informed or more detached observer would never contemplate. But when the warrant is signed or the cuffs slapped on, it’s too late for a healthcare provider to say, “Let’s slow down, back up, look at this from the beginning, and then discuss.”

That is why every healthcare provider, risk manager, medical group manager and professional needs to know the black-letter federal and state law of Schedule II-V prescriptions, and the nuances and subtleties of how the law is interpreted, what influences and impacts the agencies charged with “cracking down” on supposedly corrupt providers, and what you can do now, today, to ensure patient safety and the protection of your practice. This is why PAINKILLER LAW exists. Don’t let yourself fall victim to the subjective and loosey-goosey way law enforcement agencies and Medical Boards are defining “inappropriate,” “overprescribing,” “gross negligence,” or other concepts whose interpretation could be fraught with peril for even the most honest and ethical MD, osteopath, or physician’s assistant. Let us help you verify, achieve and maintain full compliance with the laws that well-intentioned but hopelessly biased drug agents are ever more aggressively attempting to enforce.

PAINKILLER LAW – It’s good preventative medicine.

info@painkillerlaw.com 213.293.3737 MEISTER LAW OFFICES

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PAINKILLER LAW: SEIZING OPPORTUNITY, CALIFORNIA LAWMAKER BOLDLY JUMPS ON BANDWAGON

This past Sunday, the LA Times ran a searing and exhaustively researched article on prescription drug abuse, called “Dying for Relief.” This past Monday, as is the fashion among legislators nationwide, a California lawmaker loudly reacted to the article and grabbed a headline of his own.

Ordinarily, a legislator’s jumping on the bandwagon after a big article runs in the paper isn’t news. But here it is, because in response to the national public health problem of prescription drug abuse, California State Senator Curren Price, Jr. is introducing legislation that targets healthcare providers for law enforcement action. A law enforcement approach to a public health problem typically scores political points and funds new multiagency task forces, while doing nothing to actually address the problem. And innocent people – here, legitimate healthcare providers writing legal prescriptions for approved drugs – get steamrolled in the name of public safety.

Price’s idea isn’t so outrageous: He wants coroner’s offices in California to automatically report patient deaths to the California Medical Board whenever a coroner concludes that prescription drugs caused or contributed to someone’s death.

But the devil will be in the details, because the Medical Board is under tremendous pressure to “crack down” or “do something” about Rx abuse and suspected corrupt healthcare providers. All this while California law doesn’t even define “overprescribing,” for example.

PAINKILLER LAW will be watching very closely for the language and implications of the Price bill. I’m concerned that whereas a coroner’s findings may be circumspect and sober, the Medical Board will eagerly grab the autopsy report and form a posse to go after the “bad guy.” Senator Price needs to be alert to the pressure the Board will put on him and his committee to give the Board too much latitude in investigating, accusing or proceeding against healthcare providers who’ve written prescriptions for potentially addictive drugs. The offense itself is not clearly defined, yet law enforcement will want broad discretion to target it. That’s putting the cart before the horse.

Contact PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS, for a free consultation. We want to help you verify, achieve and maintain compliance with the criminal laws of prescribing for Schedule II through V drugs.

213.293.3737 info@painkillerlaw.com Meister Law Offices

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PAINKILLER LAW: HEALTHCARE PROVIDERS WANTED — BY PATIENTS AND FOR QUESTIONING

NEWS ITEM: According to physician and medical staff recruiting firms, the most sought after healthcare providers are internists, family practitioners, hospitalists, nurse practitioners and physician’s assistants. The healthcare sector continues to grow, the population is aging, and people need and deserve quality primary care.

NEWS ITEM: According to the AMA, many patients in dire need of prescription pain medication can’t get their meds, because of D.E.A. production and distribution quotas and resulting pharmacy shortages.

NEWS ITEM: A Los Angeles area osteopath is being prosecuted for multiple counts of murder, following the overdose deaths of three pain Rx-addicted patients.

If you are a healthcare provider, what should your takeaway be from this news trifecta? I’d say (a) primary care is solid work; (b) pain patients are going to call you at midnight before a holiday weekend to ask for an early refill, which their pharmacy may or may not give them, but you’ll still get the call; and (c) if you dare step outside whatever the DEA says the current line is, you’ll wax nostalgic for your bygone days as a medical resident when sleep deprivation and verbal abuse were the worst of your worries.

If you are a patient, what is your takeaway? That people around the country, who you don’t know, are addicted to pain medication in significant enough numbers that policymakers in Washington, who you you wouldn’t want to know, are telling your healthcare provider’s nurse, who you just met last week, that your pharmacist who you’ve known for years can’t dispense the medication you need in the quantity or dose required because your doctor, who you’ve known since you met her at your wife’s niece’s Bat Mitzvah three years ago, doesn’t know her practice as well as a bunch of narco agents. Frustrated? Take a pill – wait, I’m sorry. You can’t have one.

If you are law enforcement, what is your takeaway? That come hell or high water, the “crack down” on prescription drug abuse will continue, whether it deprives patients in need of medication because of production or distribution quotas, whether it fails to meaningfully and continually instruct healthcare providers in what to do now, instead of playing “gotcha” later over some purported failure or lapse, and whether you’re even defining what it is you’re pursuing, before you set off in pursuit of it.

Until the federal government stops treating a public health problem as a law enforcement problem – I don’t expect this to happen any time soon – there’s PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS. There’s healthcare compliance, there’s HIPAA compliance, there’s compliance for every aspect of every practice – except, until now, compliance with the criminal laws governing the writing of prescriptions for pain medication. Do you overprescribe? Do you know what it means to overprescribe? What does the law in your state say? What does federal law say? What standards does your state’s Medical Board apply? What do you have to do now, to try and avoid or minimize problems later? What are the “recommendations” that suddenly morph into requirements when you’re placed under investigation – and which requirements you’re then accused of not having followed?

These are questions whose answers every healthcare provider deserves and needs to know. Let the Meister Law Offices help you verify, achieve and maintain criminal law compliance regarding prescription painkillers. PAINKILLER LAW: It’s good preventive medicine.

213.293.3737 info@painkillerlaw.com The Meister Law Offices

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PAINKILLER LAW: ARE ABUSE STATS THE NEXT “YELLOW CAKE” SPEECH?

The National Center on Drug Abuse, affiliated with the U.S. Government’s National Institutes of Health, compiled and put out a statistic awhile ago that 5.1 million Americans had taken prescription painkillers in the past month for “nonmedical reasons.” The statistic, released in 2010, is still being turned to today by the USG and others as calls to action against healthcare providers who prescribe Schedule II through V pain medication. The government’s argument then and now is fundamentally flawed, and unless it’s confronted, it threatens to become the government’s next “Yellow Cake” speech and recklessly target and penalize innocent and ethical healthcare professionals. The Yellow Cake speech, delivered to the United Nations by former Gen. Colin Powell during the George W. Bush administration, was the 16-word pronouncement that Iraq possessed weapons of mass destruction as a result of obtaining nuclear material, or “yellow cake,” from an African nation. The intel, of course, turned out to be wrong, and Gen. Powell has repeatedly said that delivering that speech is the biggest regret of his entire career.

First, the Center’s statistic itself is dubious. Who are these 5.1 million Americans? Patients? People with current, valid prescriptions? People whose dose has been monitored by their doctors? How do those surveyed draw the line between “medical use” and “nonmedical use,” and was there a static definition of “nonmedical” utilized as a standard measure from person to person? Or was “nonmedical use” a completely subjective notion, varying widely from person to person surveyed? The statistic is a compelling read, but its foundation, upon the most rudimentary examination, is shaky.

Second, the statistic says nothing about whether the source of the “nonmedical” painkillers is the user’s healthcare provider. Were these lawfully prescribed pills? Black market resells? Internet Oxy? There is no connection made between user and healthcare provider.

Third, and most importantly, the government mistakenly draws this connection in its current pronouncements about the need to “crack down” or “do something” about prescription drug abuse. The Office of National Drug Control Policy, the DEA, states’ Medical Boards and other powerful agencies are looking for someone to blame, and they’re focusing “like lasers,” to borrow from former president Clinton, on doctors, osteopaths, physician’s assistants, and pharmacists. No doubt there are some corrupt providers, pill mills do exist, drug diversion onto the black market is real, and a lot of people are addicted to prescription painkillers. But government at all levels nationwide is taking a hamfisted, impulsive, under-informed and careless approach to complaints, investigations, license revocation proceedings, lawsuits and criminal prosecutions. And with the pressure coming from legislators, patient advocates and vocal critics of prescription painkillers, the ethical healthcare provider should expect to come under investigative scrutiny even if in a different enforcement environment no official attention would be warranted.

Amid the swirling turbine of subpoenas, search warrants, legislation that second-guesses or replaces medical judgment, and other risks, healthcare providers must ensure that they are in full compliance with all criminal laws affecting and regulating prescription painkillers.

The Meister Law Offices has pioneered a critical new area of criminal defense – PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS. We are here to help. We help you verify, achieve and maintain compliance, so you can practice knowing you’re doing right by your patients and the law, and so if the law comes knocking anyway, you’re ready and able to stand up for yourself.

Call us today at 213.293.3737 for a free consultation, or write to us at info@painkillerlaw.com.

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PAINKILLER LAW: Red Ribbon Week Is About Prevention, Not Prosecution

This week has been Red Ribbon Week, the nationally observed period devoted to substance abuse prevention, and originally dedicated to the memory of slain U.S. DEA agent Enrique “Kiki” Camarena, who was murdered by a Mexican drug cartel in 1985. During Red Ribbon Week, kids and adults across the country wear a red ribbon to make a public statement about staying away from drugs, and to honor U.S. law enforcement agents who have been killed in the line of duty. But this week’s message from the White House Drug Czar should send shivers down the spine of any healthcare provider writing for prescription painkillers. Here’s why:

If you are a healthcare provider writing prescriptions for Schedule II through I painkillers, you normally needn’t think that the memory of Kiki Camarena would impact how law enforcement views you. After all, Camarena, a tough and experienced D.E.A. agent stationed in Guadalajara in the 1980′s and investigating a vast drug trafficking conspiracy reaching into the Mexican government and Army, was going after serious criminals – not your neighborhood internist or local urgent care provider. Kiki’s targets were cocaine, heroin, and big shipments of marijuana – not legitimate prescriptions written lawfully by licensed professionals. His cover was betrayed, he was kidnapped, brutally tortured, and murdered by vicious criminals, some of whom later stood trial in the United States. None of this should have anything to do with the average healthcare practitioner’s life, beyond respectfully remembering Camarena’s bravery, courage and sacrifice.

But in today’s hyper-aggressive investigative environment, with the Feds waxing on about “dope dealers with a medical license,” the line between legitimate providers and illicit traffickers is purposely being muddled by law enforcement in the name of “going after” prescription drug abuse. Look no further than the White House Office of National Drug Control Policy this past week, when its director took to YouTube and urged people observing Red Ribbon Week to bear in mind the new scourges of “teenage alcohol abuse, and prescription drug abuse.” His good faith statement about drug abuse prevention is quickly belied by the bellicose and over-the-top language used by the law enforcement agencies now under pressure to “crack down” by investigating, prosecuting or initiating administrative/licensing proceedings against healthcare providers. In an atmosphere of hysteria, which will only get worse, healthcare providers must protect themselves from government abuse undertaken in the name of stopping drug abuse.

PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS, is here to help. PAINKILLER LAW is a comprehensive service of the Meister Law Offices, and is the industry pioneer and leader in criminal law compliance for providers writing painkiller prescriptions. Don’t be lulled into thinking you will never face DEA or Medical Board scrutiny for your prescription writing. And don’t bury your head in the sand hoping nothing will happen the next time a patient makes a bogus complaint about something you did relating to a pain prescription. Call us today at 213.293.3737, or write us at info@painkillerlaw.com for a free consultation. It’s good preventative medicine.

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PAINKILLER LAW: The Healthcare Provider’s Dilemma

Prescription for Addiction,” which ran in the Wall Street Journal this past weekend, is one of the most thorough, best researched and best written articles to date on the national issue of prescription painkiller abuse.  I urge you to read the article carefully.  Among its many astute observations, the article encapsulated what I call “The Healthcare Provider’s Dilemma,” when it wrote (in summary) that providers don’t always know when a patient is doctor-shopping for more pills, and pharmacies can’t “second guess” questionable prescriptions.  Let’s break this down in terms of what it means for a doctor, osteopath, physician’s assistant and pharmacist trying to practice ethically and comply with federal and state laws governing furnishing of Schedule II painkillers.

1.  MD’s, DO’s and PA’s:  The Journal got it right: Doctor-shopping doesn’t always jump out at even the most discerning practitioner.  A provider-client of mine was recently threatened by a patient who said she’d report him to the Medical Board if he refused to refill her scrip.  (Naturally, he refused.)  Short of such explicit behavior, though, are you supposed to know every time?  The law enforcement agencies whose marching orders are to “crack down” on so-called overprescribers think so.  This, even though everyone knows that state-run PDMP‘s (Prescription Drug Monitoring Programs) vary widely in their effectiveness, real-time availability of data, and pharmacy participation, so a database’s usefulness to a provider can be very limited.  Faced with a clever doctor-shopper who wants to play you, on the one hand, and a hungry federal agent who almost hopes you get duped into writing the scrip, on the other, how are you to handle this swirling turbine of danger?

2.  Pharmacists:  You as a pharmacist probably have more room than you know, when it comes to ensuring that you’re filling valid prescriptions from righteous providers for legitimate medical purposes.  Many states expressly tell pharmacists that “no” is an acceptable answer to a patient seeking what the pharmacist may think is an excessive dose, or overly frequent refills, or anything else the pharmacist thinks would compromise patient safety or professional ethics.  But there is a fine line between calling out a drug-seeking patient or a dirty doctor, and going hogwild turning away business in the name of a one-person crusade against prescription painkiller abuse.

How to handle The Provider’s Dilemma without losing your patience or your patients?  The Answer:  Be in compliance with the state and federal laws governing prescribing Schedule II painkillers.  There are some clear statements of law, and more often there are the more murky (and therefore more dangerous, in this environment) “guidelines” for writing scrips.  You need to know that law, or have it explained to you.  Then you need to incorporate a compliance program within your practice:  From patient intake and screening, to informed consent and periodic review, to regular exams, to diligent record keeping, to making use of whatever PDMP database is available – these and related steps, in much more detail, ensure your good and ethical practice of medicine, provision of legitimate healthcare, and they show objectively to an investigating agency that you are practicing appropriately and your patients are in safe hands.  Comply now, and be thankful later, for anyone can come under DEA or FDA or Medical Board scrutiny at any time.  You can’t help it if you’re placed under investigation, but there is a lot you can do to help guide the outcome, keep yourself out of trouble, and stay in business.

 

Call PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS today, at 213.293.3737, for a free consultation.  Or, write to us at info@painkillerlaw.com.  Remember:  An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You From the D.E..A!

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PAINKILLER LAW: ONDCP TO OFFER ONLINE TRAINING IN GUIDELINES FOR WRITING PAIN Rx’S

The National Office of Drug Control Policy has announced that it will offer online training to healthcare providers, medical students and interns, and medical schools about the guidelines providers should follow in deciding whether to prescribe or refill Schedule II painkillers.  This is good news.

To be effective and useful for providers, the guidelines must have a real-world orientation, not some high-minded but utterly unrealistic set of goals providers should strive to achieve.  I strongly urge providers to incorporate study of these guidelines into their practices immediately, as a proactive means of complying with federal and state criminal laws governing the prescription of Schedule II painkillers.  This is because, as the Painkillerlaw Blog has talked about before, there are both written and unwritten guidelines and criteria that the federal and state government law enforcement agencies investigating overdoses and healthcare providers follow.  The more the government has put in writing about what you as a provider should do or pay attention to in this area of your practice, the better prepared you will be not only to care for your patients, but to defend against government scrutiny in the event you find yourself the subject of an official probe, say if a patient of yours overdoses on painkillers you prescribed.  The more you can show a government investigator you are aware of the guidelines, and you follow them every day, the better the chances that you will not be unfairly blamed for a tragedy which might befall a patient but for which you should not bear legal or professional responsibility.

PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS is a service of the Meister Law Offices, and can help you verify, achieve and maintain compliance with the written, unwritten, clear, unclear, mandatory and discretionary enforcement guidelines and criteria in place nationwide and governing prescription of Schedule II painkillers.  Call us today for a free consultation at 213.293.3737, or email us at info@painkillerlaw.com.

 

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