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: 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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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: “That’s DOCTOR Po-Po to You!”

Doctor – a physician or surgeon.

Po-Po – slang for “police.”    

 

Generally speaking, law enforcement agents haven’t gone to medical school, and healthcare providers don’t raid your house.  But today across the country,  worlds are colliding.  With law enforcement agencies from the DEA to Medical Boards to local departments nationwide feeling the heat to “crack down” on practitioners who write painkiller prescriptions, we’re seeing medical judgment scrutinized and applied by agents and police officers with no medical training.  This is a very dangerous development.  The current investigative and enforcement environment should worry any healthcare provider who writes for Schedule II through V pain medication, no matter how ethical and scrupulous and appropriate the provider and the prescriptions may be.

In California, for example, you can be investigated for and accused of “overprescribing” opioids.  The thing is, there’s no definition – statutory, case law, regulatory, even clinical – of “overprescribing.”  How to determine what constitutes it, and whether it’s occurred?  That’s a work in progress, and in a “crack down” setting, you’d better hope that your practice and career aren’t the guinea pig on which Doctor Po-Po, the badge wielding agent who thinks he or she knows medicine as well as you, is experimenting.

The investigative, accusatory and discipline processes do not provide the slightest reassurance about fairness, due process, or lack of bias.  Who gets to decide whether to investigate?  The Medical Board.  Who decides whether to formally accuse?  The Medical Board.  Who initiates the disciplinary hearing?  The Medical Board.  Who presents evidence at the hearing, in other words, who’s effectively the prosecutor?  The Medical Board.  And who determines whether a practitioner suffers discipline, including licensing sanctions – in other words, who’s the judge?  You guessed it – the Medical Board.  If you’re not scared yet, then respectfully, it’s time for B-12 injection or at least a double espresso.

Were you a common [accused] criminal, you’d be constitutionally entitled to the separation of powers that comes with a criminal prosecution.  One person prosecutes, another defends, and a court or jury judges.  Not so with your medical license and career.  Your fate could be in the hands of the same people who’ve invested the time to go after you, who are under pressure to “do something,” who know they will look like idiots if they rule against themselves at a hearing, and who will be excoriated by a legislative budget or oversight committee for being too “soft” on disciplinary targets.

There are ways to help prevent yourself and your practice from becoming trapped in this swirling vortex of bureaucratic persecution.  First, make sure you are in compliance with the laws and standards, both written and unwritten, both objective and subjective, both mandatory and discretionary, of prescribing painkillers.  There are lots of ways to do this, but you need expert help to cover them all and incorporate them wisely into your practice, your office procedures, and your staff directives.

Second, if you ever find yourself under investigation, if a subpoena arrives, or if someone carrying a badge shows up at your office and asks to have a friendly conversation about how you supposedly screwed up, do the following four things, in order:

1)   Be smart.    2)   Be courteous.    3)   Be quiet.    4)   Call Painkiller Law right away, for guidance, reassurance, advice and help.

Painkiller Law:  Criminal Law Compliance for Healthcare Providers, is a service of the Meister Law Offices.  Call us today for a free consultation on verifying, achieving and maintaining compliance with the federal and state criminal laws which govern controlled substance pain medication.  It’s good preventative medicine.

213.293.3737     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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