Steve Meister, Criminal Defense Attorney

Presents CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROFESSIONALS

Painkiller Law’s Purpose

To help providers and professionals verify, achieve and maintain compliance with the criminal laws of controlled substance prescribing, so that you (a) don’t get in trouble, (b) prevail if under investigation, and (c ) avoid criminal prosecution.

When I stop talking, you will know:

• What the law is

• Why you have to know the law

• Why you have to comply with the law

• What you can do to make sure you’re in compliance

Former Prosecutor

Defense Attorney – exclusively criminal defense

TV and Radio Commentator

Balanced and fair on air.

What is the crisis?

• Ready availability of highly powerful drugs, most notably, opioids

• Epidemic of prescription drug addiction - CDC

• Tens of thousands of patient deaths nationwide

• Shrinking enforcement budgets

• Increased scrutiny of providers, pharmacies, and healthcare enterprises and institutions

• Perilous penalties based on vague, murky laws

Why does this matter to a hospital?

Hospitals absorb medical groups and become direct employers of ever more doctors

Active federal enforcement of healthcare criminal laws – hospitals are subject to scrutiny if they accept federal funds or reimbursements

Corporate AND CRIMINAL liability for hospital

Who at the hospital is impacted?

Everyone. That’s all. Just everyone.

Don’t compartmentalize this potential problem; its impact will be felt throughout the facility and corporation.

A culture of compliance means everybody is in and it’s not just some other dept’s problem.

Snowball: An Example

Opioid related sentinel event leads to local and DEA investigation leads to record requests or subpoenas leads to grand jury investigation leads to search warrants leads to seizure of computers leads to discovery of other potential legal problems leads to widening net leads to indictment leads to arrestsleads to newsvans leads to PR crisis leads to firingsleads to giant expenditures to crawl out of the hole leads to reputational hit leads to fewer patients leads to increasing financial losses leads to existential threat. And conviction leads to Medicare exclusion leads to code blue.

What are opioids?

• A class of powerful drug, often used for pain, that includes morphine, heroin and brand names such as OxyCotinin, Vicodin, Percocet, Opana, Norco and others.

Who thought this would be good medicine?

How did we get here?

PART I:

Washington Post, January 2013:

“For years, doctors had been cautious about prescribing opioids to anyone except patients with cancer or in acute pain. But drug manufacturers and some pain specialists helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain – bad backs, arthritis, sore knees.

“Their studies reported minimal risks of addiction. These, in turn, were accepted by the FDA and the nation’s medical journals. State medical boards made their rules for prescribing opioids more liberal. Academic and industry articles dismissed the old fears as “opiophobia.”

“These reports reached doctors through marketing efforts and told them that there were few risks in using opioids to treat chronic pain.”

PART II:

At the same time, legislatures and medical schools recognized that pain was real, that patients in severe, chronic or debilitating pain needed relief, and that the medical profession generally was not adequately caring for patients in this kind of pain.

So medical school curriculum changed nationwide, and laws changed to permit and in some ways encourage this.

What No One Expected

But the Link is Undeniable

Maybe it’s not so good to be King.

“A Pain-Drug Champion Has Second Thoughts,”

Wall Street Journal, December 2012

-faulty research

-a near-religious movement at the time

-Pharma connections to studies and proponentsDr. Russell Portenoy, in a 2010 videotaped interview with another doctor:

“I gave innumerable lectures in the late 1980’s and 90’s about addiction that weren’t true…Clearly, if I had an inkling of what I know now then, I wouldn’t have spoken in the way that I spoke. It was clearly the wrong thing to do.”

Public Policy Choices

1. Take No Action

2. Ban Opioid Scrips Altogether, or Restrict Them in One Way or Another

3. Develop Abuse-Deterrent Drugs

4. Patient Outreach by ONDCP and others

5. Overdose Emergency Countermeasures

6. Increased Enforcement and Prosecution

Grasping at Straws

• ONDCP: Treatment and compassion for users

• FDA: Bal. b/w pain relief and addictive drugs

• DEA: Diversion; low-hanging fruit (Boast, Inc.)

• Medical Boards: Increased attention to providers

• Local Prosecutors: Eager, ignorant, and highly dangerous

Federal Law – the Controlled Substances Act, 21 USC 801 et seq.

Schedule II – high potential for abuse; currently accepted medical use in treatment, with severe restrictions; abuse may lead to severe psychological or physical dependence.

Oxycontin is a Schedule II drug; many other opioids are Schedule III. Tightly regulated, their manufacture and distribution are heavily controlled.

Federal Law – Code of Federal Regulations, Title 21 – Food and Drug

• FDA rules

– Drug approval

– Scientific Information

– Alerts

– Compliance/Regulatory Provisions

Federal Law and Healthcare Providers

While no one can prescribe without a DEA number, most aspects of medical practice, from licensing to prescription-writing, are not federal matters but rather are the subject of state law, in each of the 50 states.

What do the Feds do? Ask anyone busted by the DEA, prosecuted or sued by the DOJ, or fined by the FDA (that’s you, Purdue)

California State Law

Business and Professions Code:

Section 500 et seq – MD’s and DO’s

Section 3500 et seq, and CCR Title 16, Div 13.8 –Physicians’ Assistants

Prescriptions – Health and Safety Code sections 11150-11180

Laws governing writing of prescriptions by healthcare providers:

Federal: DEA’s Physician’s Manual

State (CA): B&P, H&S

Medical Board (CA):

• Guidebook to Laws Governing Practice of Medicine in California

• Guidelines for Prescribing Controlled Substances for Pain (mbc.ca.gov/pain_guidelines.html)

Authorization for Treating Pain - CA

Business and Professions Code section 2241.5(C ):

“No physician or surgeon shall be subject to disciplinary action by the Board for prescribing or administering controlled substances in the course of treatment for intractable pain.”

Exception: Allegation of gross negligence, reported negligent acts, or incompetence. Does the exception swallow the rule?

*Addiction Treatment

*To treat patients for substance abuse, a different set of requirements is set forth elsewhere in the B&P and H&S and practice codes.

Beauty is in the eye of the beholder…

And interpretation of the following phrases is in the province of law enforcement agents who don’t have medical training or work in healthcare:

What do these words mean?

• “legitimate medical purpose”

• “inappropriate prescribing”

• “excessive prescribing”

• “illegitimate prescription”

• “prescribing outside of or beyond the scope of accepted medical practice”

• “insufficient subsequent patient monitoring”

What is the MBC’s response to the crisis?

• Seeking funding – CURES, for example

• Legislation – coroner reporting to MBC; a good idea unless it turns coroners into cappers for the Medical Board

• Aggressive Investigation

• Aggressive Enforcement

Guidelines for MBC Investigation

• “INVESTIGATING PRESCRIBING OF CONTROLLED SUBSTANCES FOR PAIN POLICY

• In 1994, the Medical Board of California (MBC) formally adopted a policy statement entitled "Prescribing Controlled Substances for Pain," and "Guidelines for Prescribing Controlled Substances for Intractable Pain." Pursuant to section 2241.6 of the California Business and Professions Code, effective January 1, 2002, revised guidelines, "Guidelines for Prescribing Controlled Substances for Pain," were adopted by the MBC on August 1, 2003. These revised guidelines will provide better guidance to physicians and surgeons and to the MBC's Enforcement Program, as to whether or not allegations of inappropriate prescribing are supported by evidence.

• Investigations that involve prescribing controlled substances for acute or persistent pain shall be conducted in accordance with physician guidelines adopted by the MBC (attached). These guidelines establish standard procedures for physicians to follow when prescribing controlled substances for pain.”

When in doubt, look at primary sources

The investigative guidelines say they’re based on what healthcare providers are supposed to do; in other words, to figure out if something is wrong, compare it against what’s known to be right. So,

Mbc.ca.gov/pain_guidelines.html

…Which says, in a nutshell:

Well, actually, let’s read it together.

Hint: It doesn’t do much to clarify anything, beyond saying that examination, treatment, and monitoring all have to be within the standard of care.

What might impact the MBC’s determination of whether a violation has occurred?

“Terry Smith Collapsed Face-Down in a Pool of His Own Vomit.” –LA Times, November 11, 2012

“Dr/ Carlos Estiandan Was Up to No Good, and the Medical Board of California Was On To Him.” – LA Times, December 9, 2012

“Kamala Harris Has a Powerful Tool for Identifying Reckless Doctors, But She Doesn’t Use It.” –LA Times, December 30, 2012

The answer, in a word: THE PRESSURE TO “DO SOMETHING.”

Possible Results of a pain-med MBC investigation:

• License Proceedings; subsequent penalties

• Civil liability

• And now, more than ever before, Criminal Prosecution

– Because of the crisis

– Because of the pressure put on the MBC

– Because prosecutors smell blood in the water

What could someone be prosecuted for?

• Murder (Implied Malice; Watson)

• Manslaughter (gross negligence)

• Drug Trafficking

These are the charging results of applying the standard of care to the facts of a patient’s case. But while the facts may be clear, the standard is open to dangerously broad and varying interpretation.

What to do in response?

Compliance, compliance, compliance. Just like with everything else in your practice or group.

Compliance Checklist – what you have to be in compliance with:

• Statutes – federal and state laws and regulations

• Guidelines – governmental, industry

• Protocols – governmental, industry, group

• Definitions – of all key words in the law

• Competing Intrepretations – today’s interpretation is only as good as yesterday’s news

• Impressions and Gut Reaction – perception is reality, as obnoxious as that sounds

If you’re out of compliance and something terrible happens, here’s what you’ll want:

What the CDC Now Says

• The role of prescription painkillers

• Although many types of prescription drugs are abused, there is currently a growing, deadly epidemic of prescription painkiller abuse. Nearly three out of four prescription drug overdoses are caused by prescription painkillers—also called opioid pain relievers. The unprecedented rise in overdose deaths in the US parallels a 300% increase since 1999 in the sale of these strong painkillers.4 These drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined.4

What the FDA Now Says

• FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics

• The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses…

• Not recommended for as-needed pain.

New Johns Hopkins Study

• A new study led by the Johns Hopkins Bloomberg School of Public Health finds that during a decade when prescription opioid use has skyrocketed, the identification and treatment of pain has failed to improve, and the use of non-opioid analgesics has plateaued, or even declined

To Which Purdue Pharma Says:

• Lowering the dose doesn’t necessarily decrease risk of overdose; overdose risk depends on external factors unrelated to the drug itself

• (Presented during Pain Week convention in Las Vegas, Sept. 2013)

Comply, and you and your patients and practitioners will sleep better

How is this done?

The Painkiller Law Comprehensive Compliance Checkup. Attorney-client privileged.

• I will help you verify, achieve and maintain full compliance.

Steve Meister, Criminal Defense Attorney

Office: 213.293.3737 Cell: 213.840.4311

Email: steve@meisterlawoffices.com;

meister@painkillerlaw.com

Sites: www.meisterlawoffices.com

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Blogs: www.painkillerlaw.commeisterlawoffices.wordpress.com

Twitter: @painkillerlaw