Prescription Monitoring Programs: HIPAA, Cybersecurity and Privacy

By Stephen P. Wood

Privacy, especially as it relates to healthcare and protecting sensitive medical information, is an important issue. The Health Insurance Portability and Accountability Act, better know as HIPAA, is a legislative action that helps to safeguard personal medical information. This protection is afforded to individuals by the Privacy Rule, which dictates who can access an individual’s medical records, and the Security Rule, which ensures that electronic medical records are protected.

Access to someone’s healthcare records by a medical provider typically requires a direct health care-related relationship with the patient in question. For example, if you have a regular doctor, that doctor can access your medical records. Similarly, if you call your doctor’s office off-hours, the covering doctor, whom may have no prior relationship with you, may similarly access these records. The same holds true if you go to the emergency department or see a specialist. No provider should be accessing protected information however, without a medical need.

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What is the Role of the Judiciary in Tackling the Opioid Epidemic?

By Ryan J. Duplechin

The Judicial Panel on Multidistrict Litigation has centralized suits in the Northern District of Ohio.

As waves of opioid lawsuits have mounted in the federal courts, one district court was chosen to shepherd all the cases, and one judge is motivated to step up to stem the tide of the epidemic.

In the Northern District of Ohio, Judge Dan A. Polster was chosen by the Judicial Panel on Multidistrict Litigation, which centralized hundreds of suits, and created the Opioid MDL.

“The federal court is probably the least likely branch of government to try and tackle [the opioid epidemic], but candidly, the other branches of government, federal and state, have punted,” said Judge Polster during the first hearing of the MDL in January. “My objective is to do something meaningful to abate this crisis and to do it in 2018.”

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Hepatitis C Virus Infection: Another Consequence of the Opioid Epidemic

By Stephen P. Wood

And increase in diagnosis of the hepatitis C virus increase goes hand in hand with the opioid epidemic. (Zerbor/Thinkstock)

The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration.

There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact of the epidemic, but this is only the tip of the iceberg. Hepatitis C is another epidemic that goes increasingly hand-in-hand with the opioid crisis, and is likely to take a long-term toll on American lives as well. Intravenous drug use accounts for approximately 80 percent of new cases of hepatitis C virus (HCV) infection in the United States, and without intervention these numbers could continue to climb. Continue reading

As opioid overdose numbers rise, so does the cost of naloxone 

naloxone overdose reversal kit

Photo via bcgovphotos/Flickr

By Stephen P. Wood

Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.

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Taking a Humanitarian Approach to the Opioid Epidemic

By Stephen P. Wood 

The opioid epidemic has been declared a public health emergency, allowing for access to public health funding, in an effort to raise awareness and deploy public health initiatives. This declaration was in response to the growing numbers of overdoses and overdose deaths in the United States.

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Insurers are making it harder for me to treat my opioid-addicted patients

By Brian Barnett, via the Washington Post

Brian Barnett is an addiction psychiatry fellow at Massachusetts General Hospital/McLean Hospital and Harvard Medical School. On February 28, 2018, he was participated in the panel discussion Addiction, Neuroscience, and the Criminal Law: Commonwealth vs. Julie Eldred” at Harvard Law School. 

I’m an addiction specialist, and my voice-mail inbox is always nearly full. Some messages are from desperate individuals looking for outpatient treatment or help finding a detoxification program. Others are from patients needing a letter confirming their treatment for a child-custody dispute or care providers informing me that my patients have been hospitalized.

It’s hard to know what to expect, but invariably one type of message awaits: voice mails from pharmacies informing me that a patient’s insurance provider will not approve payment for the medication to treat their opioid addiction unless I obtain prior authorization from the insurer.  Continue reading

The Opioid Crisis Requires Evidence-Based Solutions, Part III: How the President’s Commission on Combating Drug Addiction Dismissed Harm Reduction Strategies

By Mason Marks

Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated 91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).

In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Continue reading

Civil Commitment and the Opioid Epidemic: A Call for Research

By Scott Burris, JD

There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.

With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.

The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Continue reading

The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading

Recovery Navigators: How an Overlooked ACA Program Could Be a Tool in Addressing the Opioid Crisis

By Matthew J.B. Lawrence

benefits

Research indicates that one of many challenges in addressing the opioid epidemic is getting people who are theoretically eligible for government-funded drug abuse treatment through CHIP or Medicaid to actually make use of those programs when their sickness or circumstances give them a window of opportunity to try to get help. The hassle of actually enrolling in these programs—knowing they are there, filling out the paperwork, having access to available information, and having the patience to navigate the process—is one impediment. The ACA’s sometimes-overlooked “Navigator” program could help. The ACA provision creating the program is broad enough for HHS to use it to award grants to community groups to serve as recovery navigators, enrolling addicts in Medicaid, CHIP, or Exchange coverage for substance abuse treatment.

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Fight The Urge To Criminalize Opioid Addiction Behaviors

This new post by Rebecca Haffajee appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

It’s well known that the U.S. is in the midst of a prescription opioid overdose and abuse epidemic. Adverse outcomes from prescription opioid abuse have dramatically escalated over the past decade and a half, with fatal prescription opioid overdoses roughly quadrupling and emergency department visitsinvolving prescription drugs (mostly opioids) more than doubling.

Outrageous statistics—such as that opioids were involved in almost 29,000 drug overdose deaths in 2014, or that 46 people die from a prescription opioid overdose every day—have less “shock” value now than they did several years ago. Moreover, the opioid crisis has become personal: many (including presidential candidates) have experienced a close friend or family member struggle with addiction. […]

Read the full article here.

Expanding Coercive Treatment Is The Wrong Solution For The Opioid Crisis

By Leo BeletskyWendy Parmet, and Ameet Sarpatwari

Cross posted from Health Affairs Blog

Amidst a surging crisis of opioid abuse and overdoses, many policymakers have called for expanded use of coercive treatment. Many states, including Massachusetts, already allow physicians, police, and court officers to seek a court order authorizing involuntary addiction treatment (formally referred to as substance use disorder (SUD)). But new legislation, The Act Relative to Substance Use Treatment, Education, and Prevention (STEP) currently before the Massachusetts state legislature (H.3944) could expand the scope of involuntary treatment and reduce judicial oversight.

This proposal is an ill-considered response to a public health crisis. To be sure, policymakers face an understandable pressure to take decisive action. But this approach fails to balance that imperative for speed and public confidence with sound scientific, legal, and ethical principles.

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Widespread Use of Prescription Drug Monitoring Programs to Reduce Opioid Abuse and Overdoses

By Rebecca Haffajee

It’s established that the U.S. is in the midst of a prescription opioid overdose and abuse epidemic. From 1999 to 2011, the rate of fatal prescription drug overdoses involving opioids quadrupled from 1.4 deaths/100,000 people to 5.4 deaths/100,000 people. The rate of emergency department visits attributable to prescription drug misuse (mostly involving opioids) more than doubled from 214 visits/100,000 people in 2004 to 5.4 deaths/100,000 people in 2011. Although many factors contributed to the escalation of illicit prescription painkiller use, the trend is clearly correlated with the increasing supply of opioids. A heightened focus on pain management starting in the late 1990s liberalized opioid prescribing. But in responding to the public health problem of under-treatment of pain, prescribers paradoxically have facilitated growth in prescription drug abuse. In 2012 alone, over 259 million opioid prescriptions were dispensed by retail pharmacies in the U.S. – enough prescriptions for every adult to have their own bottle of pills. Moreover, physician overprescribing has been identified as a key contributor to the opioid crisis, particularly in sourcing drugs to chronic abusers.

Prescribers, who are uniquely situated to distinguish between appropriate use and abuse of opioids and prescribe accordingly, are a natural target for regulation. Several prominent regulatory interventions recognize prescribers as opioid gatekeepers, such as the establishment of prescription drug monitoring programs (PDMPs), pain clinic laws, and mandatory opioid prescriber guidelines. Many believe that PDMPs, or state-based electronic systems that store controlled substance dispensing information and make the data available to prescribers, pharmacies, and sometimes law enforcement officials, represent a promising tool to combat opioid abuse and overdoses. And all states except Missouri have a PDMP. But prescriber awareness and use of these systems is necessary for them to have an appreciable effect. A recent Health Affairs study, Rutkow et al. used a nationally representative sample of primary care physicians and found that while 72% of physicians were aware of the their state PDMP, only 53% reported having ever used it. A number of barriers to use were identified, including the time-consuming nature of retrieving information, and the lack of intuitive format for the data provided. The authors conclude that PDMP legal mandates may increase prescriber use of the programs. Continue reading

Another Legislative Win for Opioid Death Prevention

By Scott Burris

The rising public and legislative awareness of opioid overdose has been a case study in the twists and turns of culture, risk perception and the role of evidence in policy making. An interesting case study, which does not mean I understand what happened or why.

I first got involved in overdose through Dan Abrahamson, the Legal Director at the Drug Policy Alliance. This was back in 1999 or 2000, and a group of drug researchers and drug policy people convened a meeting in Seattle to discuss the chronic, neglected problem of overdose among heroin users.  There were a few health people who were highly aware of the human and economic costs, and the scale of the problem. Karl Sporer, a San Francisco ER doc, was one of the few publishing on the problem. One of the interesting ideas discussed at the meeting was distributing naloxone, the standard antidote for opioid overdose, directly to heroin users. New Mexico, which had the nation’s highest OD death rates, was trying it as a way to deal with the great distances that divided rural heroin users from EMS assistance. With Joanna Norland and Brian Edlin, I ended up writing an analysis of the legality of distributing this prescription drug to drug users.

In the next few years, led by people like Dan Bigg of the Chicago Recovery Alliance, needle exchange programs in urban areas began naloxone programs. They were spurred in 2006 when several US cities experienced an epidemic of overdose tied to the adulteration of the heroin supply with a synthetic opioid, fentanyl. By May, 2009, 57 naloxone programs were operating in 17 U.S. states.  That year, DPA funded a group of scientists and practitioners to brainstorm on how to increase drug users’ access to this life-saving intervention.  Continue reading