PAINKILLER LAW BLOG: The FDA’s Original Blessing Isn’t a Pain Doc’s Original Sin

Doctors who prescribe opioid painkillers to chronic pain patients are, as we know, the subject of intense regulatory and law enforcement scrutiny today. Many of my doctor-clients are under investigation or being charged for supposed crimes arising out of their prescription writing. While every case is different, to me there is a universally applicable defense that should be raised on doctors’ behalf in court against a criminal charge.

That defense relates to lack of criminal intent, since opioids’ addictive power was not known or acknowledged until years after the drugs’ approval for mass use. Today, a criminal charge is at its essence a misguided and ill-considered way of blaming doctors for not having seen the future, for not having foreseen what would happen, even though government regulators and even the drug manufacturing companies didn’t see the abuse crisis coming, either.

The FDA originally blessed the prescribing of powerful and potentially addictive medication for chronic pain. We now know that the scientific evidence offered by Big Pharma about the safety of the medications for chronic pain was incomplete at best, wrong at worst. There are attempts being made today by counsel in various parts of the country to uncover any possible funny business or overly cozy relationships which may have existed between government regulators and private business (Pharma advocates) during the drugs’ approval process years ago. Is this the Erin Brockovich-like scandal waiting to break? Could be.

Whether or not a scandal exists or will be revealed, though, it still must be noted that doctors were the ones who were told by the FDA and the pharmaceutical companies that drugs like Oxycontin and other opioid-based painkillers were safe and effective for chronic pain. The addiction risk was significantly downplayed or underestimated by regulators and manufacturers. The drug companies unleashed a marketing and advertising juggernaut to persuade patients that the miracle pain drugs had at last arrived. That was then; this is now. And now that we know the drugs so frequently lead to addiction, we can change the advice and practice guidelines given to doctors, but we cannot hold them legally accountable for not knowing what the rest of us didn’t know, either – or what some people in the game may not have revealed – years ago.

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PAINKILLER LAW: D.E.A. WINS TODAY; PATIENTS WILL LOSE TOMORROW

The FDA today concluded its highly watched two-day meeting on prescription drug abuse, notably – and erroneously, in PAINKILLER LAW’s opinion – endorsing a hardline proposal from the D.E.A. If the D.E.A. gets its way, and hydrocodone is reclassified as a Schedule II drug, patients will lose, and access to needed medication will be callously impeded.

The D.E.A has been pushing for this change, and the FDA panel by a close vote of 19 to 10 may be mistakenly coming around to the the D.E.A.’s position. Advocating similar change is a prominent doctors’ group, Physicians for Responsible Opioid Prescribing (PROP). But the coincidental joining of these two forces – cops and docs – doesn’t make the idea any more credible. This proposal if implemented could rigidly and with unreasonable orthodoxy deny thousands of legitimate pain patients access to the medicine they need. PROP and the D.E.A. in this instance seem to trust no one but themselves to decide for everyone else what medicine should be taken and for how long.

A direct and intended consequence of the D.E.A. proposal is that only MD’s could prescribe even Vicodin from now on. That means if you had dental surgery coming up, and your dentist told you it was going to be a tough recovery, he or she wouldn’t be able to give you even a few days’ worth of Vicodin for head-splitting midnight pain. You’d have to get that from your MD, after the pain was already knocking you over, or you’d have to get to the E.R. in the middle of the night to seek some relief. Why must the D.E.A. presume that ordinary citizens can’t be trusted to not become addicted to opioids even though they’re only given a three-day dose for acute pain?

This also means that if you see a physician’s assistant for your medical care, that person would no longer be able to write for certain pain medications, at all, ever. Is that reasonable? Is the D.E.A. making a competency judgment about licensed professionals? Is the agency dismissing the state legislatures and medical boards that have determined the legitimacy and licensing standards for PA’s in every state in the Union? Does the D.E.A. not care that frequently, PA’s serve patients in medically underserved communities? Did the D.E.A. not get the memo: That legislative support for PA practice often stems from the precise policy goal of getting qualified healthcare providers to those communities who need them most but have them least?

The best course is for the FDA to reject the D.E.A’s proposal. Expect the D.E.A., possibly PROP, and others to in good faith continue to pursue ultimately unsound idea. And remember that no amount of good intentions makes a bad idea better.

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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: Physician (and Physician’s Assistant), Heal Thyself

Recent Texas Medical Board actions bear mention just before the holidays, and are of particular interest to physicians’ assistants and their supervising MD’s or DO’s.  The TMB just handed down license revocation/suspension penalties against three PA’s and their supervisors, in cases of alleged “pill mills.”  Either the PA was accused of inappropriately prescribing, or the supervisor accused of inadequate supervision, or both.

Head into 2013 with the following tips in mind, if you work in a clinic or medical group that could, by virtue of its very existence, become a target of official inquiry:

For PA’s:

1)   Make sure your Delegated Services Agreement is up to snuff and up to date. Check with your state’s licensing authority as well as professional advocacy organizations or statewide trade groups to make sure the language of your DSA complies with the law of your state, and with federal law.

2)  DEA Number:  If you are authorized to write scrips, are you DEA-current?  Expiration dates can sneak up on you.  Whether you or the office staff keeps track of these matters, give it a year-end check just to be sure.

3)  Is your supervisor actually doing his or her job of reviewing your files at least as often as required by your state’s law?  In California, a supervising MD or DO is supposed to review all PA files every 7 days, especially when Schedule II – V prescriptions have been written.  If you don’t think your supervisor is in compliance, get on him or her to get with the program.  If they balk, weigh your options and always err on the side of staying in compliance with the law, whether it’s at that clinic/office, or another one.

For Supervising MD’s/DO’s:

1.   Don’t fall short in checking charts regularly and thoroughly.  If you are not in compliance with this basic requirement of PA supervision, achieve and maintain compliance immediately in order to (a) ensure patient safety, (b) be a helpful and responsible employer who invests in your employees, and (c) take an easy “find” away from investigators should you come under official scrutiny.

2.   Chart it, chart it, chart it.  Make sure charts are up to date with any advice/feedback/correction given to a PA by you upon chart review.  Again, patient safety will be enhanced, and regulators and investigators will see your diligent efforts to comply and properly supervise.

3.   Make sure your office’s and staff’s efforts and procedures for utilizing your state’s Prescription Drug Monitoring Program are current, understood and practiced every day.  You can’t catch every doctor shopper, and to be sure, PDMPs’ technology leave a lot to be desired, but you still need to do all you can.

4.    Create and nurture an environment of collaboration and communication with PA’s in your office, on all subjects of patient care but especially about Schedule II through V prescriptions.  A culture of candor and compliance is readily apparent to an inspector, investigator, regulator or law enforcement agent.  There are lots of ways to this, but it all starts with office culture, and that starts with you.

And with that, friends, Merry Christmas, happy holidays, happy new year to everyone, and PAINKILLER LAW will be back after January 1.

 

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PAINKILLER LAW: WARM BLANKET, COLD TRAIL

“The Warm Blanket” is how many opioid users describe the feeling of being under the drugs’ influence.  Orally or injected, and regardless of the reason(s) the drugs may be taken, this description has been documented across the user spectrum.  PAINKILLER LAW’s position on prescription drug abuse is that even if a patient or an addicted person – or an addicted patient – needs the warm blanket, that does not necessarily mean criminal or civil liability should rest with a prescribing healthcare provider.  In other words, in all but the most extreme cases, the blanket is warm, but the trail back to the ultimate question of “why?” is appropriately cold.

And speaking of “cold,” I don’t mean to sound cold or heartless saying that.  Grieving parents of deceased addicted children need comfort, not a lecture.  None the less, it is true that healthcare providers are generally NOT to blame for prescription drug abuse.  Here’s an example:

This past Thanksgiving Day in Minneapolis, two teens broke into a man’s home to steal prescription medication.  They weren’t looking for iPads or a flatscreen TV or even cash; they wanted pills.  The homeowner shot both teens dead.  For reasons not yet fully disclosed by police, he’s being charged with murder.  But my focus is the teen burglars.

Let’s assume the teens were addicted to prescription pills, let’s say opioids.  They committed the crime to feed their habit one way or another, either by planning to ingest the drugs themselves, or by selling them to buy other drugs for personal use.  Let’s further assume that the teens were first prescribed opioids by a legitimate healthcare provider.  They became addicted over time; to not feed the habit now would bring on the days-long agony of withdrawal.

Who is liable for the burglary?  The teens; they did it.  Who, if anyone, is liable for the act of killing them?  The homeowner, if he can’t claim self-defense, which you’d expect he’d be able to do.  But if the homeowner is charged, can he defend himself by blaming the doctor who prescribed the opiates to the teens?  Is there a causative link between the prescriptions, and addiction-fueled criminal behavior, sufficient to excuse the homeowner from killing them?  Should the healthcare provider be sued by the teens’ parents for wrongful death at the hands of the homeowner?  Should the healthcare provider’s act of prescribing be criminalized, independent of the burglary or murder case?  Should the very act of having written scrips for these teens end up with a doctor, or osteopath, or physician’s assistant, or nurse practitioner, stripped of their license and doing hard time?  Would a healthcare provider still be liable if the teens had not committed a crime?

There are already some states, like Florida, which criminalize “overprescription,” if anyone can define it, and I’d challenge you to come up with a durable, scientific and constitutional definition.  Then there’s my state, California, whose law conveniently doesn’t define “overprescribing” but whose law enforcement agencies still try and charge it.  And there’s a national law enforcement drumbeat to “do something” about prescription drug abuse by targeting legitimate healthcare providers writing reasonable prescriptions for approved drugs.

What are your answers to the questions above?  My answer to all of them is an emphatic “no.”  And even if reasonable people can disagree, that only means the issues are too complicated for law enforcement agencies to handle prescription drug abuse as though this were a straightforward issue with an easy remedy.  As the old saying goes, “For every complex problem, there’s a simple solution, and it’s wrong.”

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PAINKILLER LAW: The Provider’s Dilemma, Part Two

Healthcare providers writing legitimate prescriptions for pain medication today swim in shark-infested waters.  Every provider needs to protect herself or  himself from the crusading law enforcement agencies that presently are happy to shoot first and ask questions later in the new effort to “crack down on” or “do something about” prescription opioid abuse.  In previous posts I have coined the phrase, “The Provider’s Dilemma,” to describe the conflict faced by physicians, osteopaths and physician’s assistants in prescribing Schedule II through V medication for patients with severe, chronic or debilitating pain, on the one hand, and providers’ being subjected to unwarranted or impulsive administrative or criminal scrutiny for prescribing pain medication, on the other.  Today I elaborate on The Provider’s Dilemma, with special attention to two news releases which, ironically, came out within hours of one another.

The first release was from Virginia Commonwealth University’s Spine Center, which in a recent study found that long-term intrathecal opioid treatment can be beneficial for pain management and reduction.  The study cited concerns about tolerance, absence of relief, or development of dependency which can occur with patients taking oral opioids, but the study did nothing to undermine or debunk the notion that these drugs can bring much needed relief to patients suffering from real pain.  The science continues to be in line with patient-care policy in states like California, and with the instructional and philosophical approach taught in the nation’s medical schools for the past few decades:  That good medicine includes treating pain patients in need.

But then, in the second news release, the White House Office of National Drug Control Policy (“ONDCP”) boasted of the recent summit it had with a dozen or so other federal agencies, including the Justice Department, on the Office’s #1 priority:  Fighting what it once again called the “Prescription Drug Abuse Epidemic.”  Just the issuance of this release by the ONDCP should be enough to give pause even to the most scrupulous and conservative healthcare practitioner, mid-signature on the prescription pad.  This is because the awesome power of the White House, the D.E.A, and the rest of the federal government is today arrayed and ready for what the government considers the latest iteration of the War on Drugs.  Only this time, they’re pursuing healthcare providers instead of cartel kingpins, and the scourge they’re deploying against is for legitimate and lawful prescriptions, not street drugs.

What should you do?  On the one hand, the people who tell you it’s still OK to use your best medical judgment in writing painkiller prescriptions carry the wise words of Hippocrates.  But the people on the other side of the issue carry badges and guns, and the blessing of federal, state and local government to come after you if in the “considered” opinion of a prosecutor or cop with not one day’s medical training, you’ve crossed the line in prescribing opioids for pain.

What are your options?  You can stop writing prescriptions for any opioid painkiller and hope for the best, not only for yourself but for your patients whose medical needs you may end up neglecting.  Or, you can carefully and thoroughly incorporate best practices into how you assess, diagnose, treat and monitor anyone who needs pain relief, and be in compliance with federal and state criminal laws about writing for these medications.

That is where Painkiller Law: Criminal Law Compliance for Healthcare Providers comes in.  Painkiller Law is a comprehensive legal service offered by the Meister Law Offices.  We provide a top-to-bottom review of your practice to enable you to verify, achieve and maintain compliance with applicable laws, incorporate best practices into all you and your staff do, know where the red flags might be, and stand with you if you ever find yourself under investigation.  In the current enforcement environment, you cannot control whether the D.E.A. or F.D.A., or your state’s Medical Board, start looking at you.  You do not, however, need to be at their mercy.  Be in compliance, be ready, and thereby be best positioned to prevail.

Call Painkiller Law today for a free consultation, at 213.293.3737, or email info@painkillerlaw.com

 

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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: THE NEW “BLAME GAME” IN Rx ABUSE

Did you as a medical doctor, osteopath, physician’s assistant or pharmacist know that YOU are to blame for Rx abuse nationwide?  The White House Office of National Drug Control Policy is placing new emphasis on treatment and prevention of Rx abuse and urging a new, more “compassionate” model be adopted when it comes to how patients abusing prescription painkillers should be approached.  But blame for Rx abuse has to be placed somewhere.  And so it has been placed on healthcare providers who write painkiller prescriptions, and the pharmacists who fill them.

Look no further than an article in Wednesday’s Wall Street Journal for proof.  The article, “Making the Pharmacy Crawl,” explains that patients in many states have to travel to several pharmacies to fill legitimate prescriptions, as a result of new laws’ making “doctors criminally liable and revok[ing] their licenses for writing prescriptions for painkillers that lead to overdoses.”  This, in combination with pharmacies’ being subject to stricter limits on how many opioids they can dispense in a given period, has led, says the article, to a reduction in the number of doctors writing prescriptions, and in pharmacies’ not being able to fill what even a legitimate patient with a legitimate scrip might need. Is this really helping people? Or is it placing doctors’ judgment under a microscope, allowing if not requiring scrutiny of medical judgment, by government agents with no medical training or experience?  Is it substituting pharmacists’ judgment, discretion and ethics for hard and fast marching orders from the DEA?  Is it going to do anything to crack down on what the government calls the prescription painkiller epidemic, or will it just make people’s lives harder, subject them to more unwanted bureaucracy, and punish ethical practitioners and legitimate patients along with a few corrupt practitioners and drug addicts?

Ham-fisted governmental action that creates unintended consequences for good and law-abiding people abound, especially in an environment like this where the government is basically feeling its way as it goes.  When government treats a public health problem as a law enforcement problem, there is going to be a lot of collateral damage behind every press release or high profile arrest.  Don’t be the collateral damage.  Protect yourself and your practice from governmental heavyhanded behavior, by being in compliance now with all applicable criminal laws about prescribing painkillers.  Compliance goes a long way; it makes for ethical and sound patient care; it gives you peace of mind that if you’re ever investigated you will be ready; it helps persuade law enforcement that you are practicing appropriately and properly; and it acts as a foundation for a defense if you ever need.

Call Painkiller Law, a service of the Meister Law Offices, today for a free consultation on how to verify, achieve and maintain criminal law compliance in writing prescriptions for pain medication.  It’s good preventative medicine.  213.293.3737, or write us at info@painkillerlaw.com.

 

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PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS

For Medical Doctors, Doctors of Osteopathy, and Physician’s Assistants:

An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You from the D.E.A.

If you are an MD, DO or PA, you worked very, very hard, for many, many years to earn your degree and license, and build your practice to success. You didn’t suffer through medical school or undertake grueling PA training in order to get indicted. So why let investigative priorities dictated by Washington politicians and bureaucrats, which translate into aggressive and sometimes reckless law enforcement activity, target you unfairly and threaten your life’s work?

It is a sad truth of healthcare practice today that providing patients with needed relief for severe, chronic or debilitating pain can be dangerous business. Dangerous because you have the D.E.A., the F.D.A., Medical Boards, state regulators and local law enforcement looking over your shoulder to see whether you are “prescribing without a legitimate medical purpose” or “practicing outside the accepted standards of medicine.” Who even knows what those vague statements mean in a given situation? Whose judgment should control – that of the healthcare professional, or of a federal agent without a day’s medical training?

As many questions as current law enforcement policy and practice beg, most healthcare practitioners are not prepared for the day when the D.E.A. shows up with a warrant, accusing them of being nothing more than highly educated drug dealers. Such heavy handed tactics – in use with alarming frequency across the country, and boasted of by law enforcement agencies – can rattle even the most ethical and seasoned practitioner.

Be ready. Be in compliance with the laws governing prescription of Schedule II painkillers and pain medication, and let the Meister Law Offices help. Do this before the door-knock, before the subpoena, before the administrative inspection, before the D.E.A. or its counterparts have made up their minds about you. You can’t necessarily stop the government from investigating you, but if you are in compliance with laws governing prescription of Schedule II painkillers and pain medication, you don’t need to stop anything. You need to prevail in the end, and the best chance you have is to be in compliance before the inquiry ever starts.

From patient intake to prescription practice, use of electronic databases to protect against doctor-shopping, from internal controls to ongoing government-sponsored training for you and your staff, we will tell you how you are in compliance, what areas might deserve additional attention, and how to maintain a compliant practice that serves your patients safely, ethically and properly within the meaning of the applicable criminal law.

Call the Meister Law Offices today at 213.293.3737 for a free consultation.

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