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.
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
By Rebecca Haffajee
In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.
State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.
Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.
By Rebecca Haffajee
Sure enough, last Friday the American Beverage Association and others, represented by Latham & Watkins, sued to block Mayor Bloomberg’s ban on the sale of sugar-sweetened beverages larger than 16 oz at certain NYC vendors. The suit, filed in the NY Supreme Court, asserts that the Mayor bypassed the proper legislative process for governing NYC, instead imposing the ban by executive fiat. The petition cites the many proposals considered and rejected by the NY City Council and NY State Legislature with respect to sugar-sweetened beverage (e.g., excise taxes, restrictions on the use of food stamps, warning labels, and product placement rules) as evidence that the legislature has chosen not to act to restrict sales in this sphere. The petition also claims that the scope of the Dept. of Health (DOH) action here is unprecedented, despite the fact that the DOH banned the use of trans fats in foods and required calorie postings at enumerated food service establishments.
Several specific causes of action are alleged by the soda industry, including:
- that the New York City Charter, in it’s general language, does not delegate the necessary enumerated powers to the DOH to implement such a ban;
- that even if authority to enact the ban has been delegated by the legislative branch to the executive branch, such delegation is unconstitutional as in violation of the separation-of-powers doctrine (i.e., the legislature cannot cede its fundamental policy-making responsibility to an administrative agency); and
- that the ban fails to pass rational basis review given it’s arbitrary features that are unrelated to it’s stated purpose (e.g., cutoff at 16 oz size, exclusion of alcohol, and application to certain food establishments but not grocery or conveniences stores).
The plaintiffs request that the court enjoin and permanently restrain the ban. They also want a decision by Dec. 15, 2012, so that affected businesses can avoid expending funds to comply with the law (set to take effect March 12, 2013). A response from the DOH will be forthcoming before an eagerly awaited court decision. A Cleveland Judge recently sided with the city when it sued the State of Ohio for trying to preempt its regulation of trans fats. Cleveland, the Judge ruled, was within its powers under the State constitution. But this most recent soda ban challenge applies to a different state’s legislative scheme, and a finding in favor of the plaintiffs could render Major Bloomberg’s “War on Fat” via other initiatives also susceptible to challenge.
By Rebecca Haffajee
As many are aware, the New York City Board of Health recently approved Major Michael Bloomberg’s proposed ban on sugar-sweetened beverages (SSBs) over 16 ounces in size sold at city restaurants, delis, sports venues, movie theaters, and street carts. This “soda ban” is set to go into effect on March 12, 2013. It has been justified on the grounds that it will make headway in combating obesity in NYC. It piggybacks on a number of other anti-obesity policies enacted in the City, including a transfat ban in restaurants, a requirement that chain restaurants post calorie information, initiatives to help low income residents buy fresh produce, and nutritional standards in schools. In this Blog, Katie Booth conducted a thorough legal analysis of whether the ban could be overturned, concluding that a plaintiff’s chances of waging a successful lawsuit are slim. Meanwhile, robust commentary in the media and health journals has debated the legitimacy of the ban and government’s role in regulating SSBs and combating obesity.
So what do we know about obesity in the U.S. as a phenomenon, its causes, and possible interventions that work to combat its spread? Although the problem is far from simple, it’s useful to briefly compile the current evidence.
by Rebecca Haffajee
Earlier this week, the Boston Globe reported that medical debt is still a problem in Massachusetts, with scant change since the implementation of health reform legislation in 2006. Specifically, the article reports that of approximately 3,000 adults surveyed in 2010, 17.5% had trouble paying medical bills in the past year and 20% were carrying medical debt and paying it over time, statistically insignificant changes since 2006. The source of this finding is the Massachusetts Health Reform Survey (MHRS) funded by Blue Cross Blue Shield of MA Foundation, whose latest results published in January 2012 track annual trends from 2006 – 2010. The Globe story seems to suggest that in the absence of reductions in medical debt, health reform is failing to achieve one of its goals. The survey findings, however, don’t present a story of causal inference; they (at best) identify a loose association.
Just to recap some basics of MA health reform: the law required most residents to obtain insurance. It established Commonwealth Care through the Health Connector – an exchange of sorts – so that low income residents not eligible for Medicaid could qualify for a subsidized plan. The Connector also offers Commonwealth Choice non-subsidized plans for individuals and employers. Since passage of the law, insurance coverage among MA residents has increased from 94% to 98%.
The MHRS study design consists of 1 “pre” measurement, or the survey fielded in 2006 just before reform implementation, and 4 “post” measurements (2007-2010). This design fails to provide a reliable counterfactual that reveals what would have happened in the absence of the health reform “treatment”. A slightly better design would have administered survey questions for many years before health reform implementation. But even this design would be considered somewhat weak for causal inference given the presence of other factors that could have happened concurrently with the policy change that could explain outcomes. For instance, the recession could dramatically impact how much medical debt is incurred or not paid off, even with health insurance — especially with the proliferation of high deductible health plans in recent years.
We’re excited to introduce and welcome Rebecca Haffajee to our blogging community as a regular contributor (probably with a bit of a hiatus around November).