"Graham-Cassidy" Provides Zero Funding to Address the "Opioid Crisis"

By Elisabeth J. Ryan

One of the few positive provisions of the summer’s Senate “health care” bills was the inclusion of funding to states to “support substance use disorder treatment and recovery support services.”  With more than 30,000 people dying from heroin and painkiller overdoses in the United States every year, sufficient funding to address and effectively treat this issue is crucial.  Yet the latest Republican version of the “health care” bill has omitted this funding entirely.

The original Better Care Reconciliation Act included a $2B fund to distribute grants to states for fighting the “opioid crisis” and other substance use disorder issues; the “Cruz amendment” version significantly increased that amount to nearly $45B over nine years.  While even that amount would likely not have been sufficient to cover needs, the increase was hailed as a key provision aimed specifically at some Republican Senators still wavering in their support.  Yet the latest iteration – “Graham-Cassidy” – includes absolutely no such funding.  This glaring omission has received little attention, but it contributes to the bill’s overall potential to actually harm public health.  The bill would also make alarming cuts to Medicaid (which is one of the top insurers for substance use disorder services) and would also allow states to waive the current requirements that insurance companies not only cover substance use disorder treatment but also that they cover it without charging people higher premiums.  One analysis estimates that a person with "drug dependence" could face a premium surcharge of $20,000 per year.  

Without any funding added to the bill to offset those potentially devastating losses, treatment for substance use disorder will become either financially or practically impossible for the millions of people who may need it.  This lack of adequate, evidence-based, available treatment already constitutes a public health crisis - Congress may be poised to make it even worse.  

The Tanning Tax is a Public Health Success Story [from Health Affairs Blog]

Elisabeth Ryan wrote a piece about the "tanning tax," posted today on the Health Affairs Blog.

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Among the lesser known provisions in the now-rejected Republican House and Senate health care bills was a plan to eliminate an excise tax on tanning bed use. Tanning first became fashionable when Coco Chanel popularized the practice in the 1920s, making lounging outside in the sun a symbol of leisure, relaxation, and health. In the late 1970s, pioneering businesses began to offer ultraviolet (UV) radiation beds as a shortcut to fashionable tanned skin; by the 1990s, indoor UV tanning services were ubiquitous staples of the American beauty industry.

Despite its popularity, research has shown that exposure to UV radiation is the primary environmental cause of skin cancer and tanning beds are “the main source of deliberate exposure to artificial UV radiation.” Melanoma risk is particularly high among individuals who use tanning beds for the first time before age 35. The practice remains most common with female college students in the United States, with more than 50 percent reporting having used indoor tanning beds. Furthermore, despite their higher risk for melanoma, tanning companies aggressively target this demographic through the use of tailored marketing and advertising techniques.

Both the House and Senate health care bills would have repealed the Affordable Care Act’s so-called “tanning tax,” a 10 percent consumer-paid tax on non-medical, UV light indoor tanning services. When the tax was enacted in 2010, the non-partisan Congressional Joint Committee on Taxation estimated that it would bring in $2.7 billion in revenue over 10 years, and would offset some of the costs of the ACA overall. After four years, however, the tax had only brought in about $367 million, far less than the approximate $1 billion originally projected by that time. Some detractors then declared the tax a “failure” and blamed it for the loss of tens of thousands of jobs.

Yet these arguments discount the notion that the revenue was perhaps a secondary goal of the tax, behind its ability to deter people from engaging in the dangerous pursuit of indoor tanning. Per medical and public health groups, the creation of the tax was “a clear signal from the federal government that indoor tanning is a dangerous and potentially lethal activity that Americans should avoid.” The American Academy of Dermatology hailed it as helping to “reduce health costs by discouraging indoor tanning and thereby reducing the future costs of treating skin cancers.” From the public health perspective, a lower-than-expected revenue could be indicative of a significant victory.

Unsurprisingly, the indoor tanning industry criticized the tax from the beginning and now blames the tax for closing upwards of 10,000 salon businesses. Salons have the option of collecting the tax directly from consumers or absorbing the tax themselves; one survey of tanning salon owners in Illinois showed that about 80 percent chose the former, adding 10 percent to the consumer charge up front. The owners in that survey also reported that younger clients were more likely to “notice or care” about the price increase than older clients. Indeed, the Centers for Disease Control and Prevention reported that the number of high school students who reported having artificially tanned has decreased by more than half since the enactment of the ACA, from 15.6 percent in 2009 to 7.3 percent in 2015. While this may signify a downturn from a business perspective, deterring younger clients from beginning or continuing indoor tanning is a particularly desirable public health goal, as “young women under the age of 25 who engage in indoor tanning have been shown to be over 60 percent more likely to develop skin cancers such as basal or squamous cell carcinoma compared to those who have never engaged in the behavior.”

Given Congressional Republicans’ failure to repeal the Affordable Care Act, the elimination of the tanning tax appears to be off the table, at least for now. But the industry may well push for repeal again, possibly through the tax reform initiative Congress seems poised to address. Before Congress acts, however, it should recall that although the revenues raised by the tax may be relatively small, its true goal should be to reduce indoor tanning, especially among young people. Although far more research is needed to establish causation, the apparent reduction in rates of tanning that has occurred since the tax’s enactment suggests that the tax may well be doing its job.

FDA Reboots Tobacco Regulation with Harm Reduction

By the Public Health Advocacy Institute

On Friday, July 28, 2017, U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb unveiled a revamped approach to tobacco product regulation in an announcement that surprised tobacco companies, investors, and the public health community in equal measure.  The goal, as articulated by Gottlieb, will be to regulate products so as to encourage migrating existing consumers from the most lethal combustible tobacco products (i.e., cigarettes) to non-combustible products lower on the continuum of risk. This approach is known as “harm reduction.”  The keystone will be to promulgate product standards so that cigarettes deliver insufficient nicotine to users to create or sustain addiction so that current nonsmokers never start and current smokers either quit or switch to non-combustible tobacco product that present a lower health risk.

This idea, while somewhat radical, is not new.  It had been a topic of discussion at the American Medical Association in the mid-1990s. Congress gave the FDA regulatory authority over tobacco in 2009 with the Family Smoking Prevention and Tobacco Control Act of 2009 (“Tobacco Control Act”).  It prohibited the agency from banning cigarettes or from banning nicotine.  The law does, however, explicitly allow for the potential reduction of nicotine in cigarettes to any level above zero.  The Public Health Advocacy Institute at Northeastern University School of Law produced a white paper on this approach in 2009 and proposed further research on the policy, but enthusiasm at the agency and the Executive Branch was lacking. Northeastern University Distinguished Professor, Richard A. Daynard, characterized non-addictive cigarettes in the New York Times as one of two important strategies that could end the cycle of addiction, disease, and death from tobacco products.

Research to date, including a $50 million research project funded by the National Institute on Drug Abuse, have produced preliminary results supporting the notion that very low nicotine cigarettes will lead to fewer cigarettes smoked and reduced toxic exposure to consumers.  So long as the nicotine levels are very low, compensatory smoking behaviors such as inhaling more deeply and smoking greater numbers of cigarettes do not seem to generally occur.  Some of these preliminary results were presented at Northeastern University School of Law in 2014 by a Principal Investigator of the grant, Dorothy Hatsukami, at PHAI’s conference, “Accelerating Tobacco Endgame Strategies in the United States.”

Another important tool that the FDA can use is to issue rules pertaining to the use of flavors in tobacco products.  While the Tobacco Control Act banned the use of characterizing flavors other than mint or menthol in cigarettes, concerns around the role of flavors in tobacco initiation have intensified in recent years.  “Little cigars,” which closely resemble cigarettes, are available in a range of child-friendly flavors.  E-cigarettes, likewise, have been criticized for offering fruit and candy flavors that would seem to appeal to children.

The question of exempting menthol flavored cigarettes from the flavor ban has been extremely controversial.  The Tobacco Control Act, it was thought, would not have garnered the votes needed to pass Congress were a menthol cigarette ban included.  Rather, the law specified that an expert committee must be convened by FDA to study the issue and issue a report on the health impact of menthol as a characterizing flavor in tobacco products. 

The resulting reports concluded that although menthol itself did not contribute to the toxicity of tobacco products, it tended to anesthetize the lungs in a way that facilitates smoking initiation by youth and frustrated cessation efforts.  Further, mentholated cigarettes have been historically marketed in a way that targets African Americans.  Almost 90% of African American smokers prefer menthol cigarettes, which is the most robust sector of the cigarette industry in the United States.  The company that produces the menthol market leader, Newport, was recently acquired by R.J. Reynolds which, in turn, was acquired by British American Tobacco this year. Reportedly, much of the value sought in these acquisitions derived from the Newport brand and the value of menthol cigarettes.

To date, the FDA has taken no action on mentholated tobacco products.  Chicago and San Francisco have passed ordinances restricting sales of menthol tobacco products.  San Francisco’s ordinance, which passed in July of 2017, is a total ban on all flavored tobacco product sales, including menthol.

The FDA announced that it will soon release three Preliminary Notice of Proposed Rulemakings seeking public and stakeholder comment on: 1) pros and cons of nicotine reduction strategies; 2) role of characterizing flavors, including menthol, in youth initiation and as a means to attract smokers to non-combustible tobacco products with less risk; and 3) potential health risks and use patterns of premium cigars. 

Non-combustible products such as electronic nicotine delivery systems including e-cigarettes and emerging “heat-not-burn” products would be likely alternatives to non-addictive cigarettes as would nicotine replacement therapies such as the gum and patch.  While this harm reduction approach has many supporters in the public health community, it would have the likely effect of perpetuating the commercialized recreational use of nicotine long into the future. 

Since the FDA began regulating tobacco products in 2009, almost every substantive regulatory effort has been met with litigation. This includes 2 lawsuits challenging a host of the law’s provisions; challenges to the legal legitimacy of the report FDA issued about menthol; a successful First Amendment challenge to regulations for graphic cigarette warning labels; and a dozen or so lawsuits challenging the agency’s regulation of e-cigarettes and cigars. 

This litany of litigation has, to this point, slowed or partially derailed the agency’s regulatory agenda and has drawn the criticism of many in the public health community. The FDA’s announcement marks a new and more aggressive regulatory vision for tobacco. Many questions remain. Is the scientific evidence base sufficient to justify this new approach?  What will be the effect of inevitable legal challenges from manufacturers and smokers? What are the health impact of non-combustible tobacco products to users and non-users?  How did the political environment in the Executive Branch change to allow for this new strategy to emerge and will it last?

With so many questions remaining and so many potential rules to enact, the timeline for the FDA to implement its new regulatory approach is uncertain.  Based on past experience, it would be reasonable to expect that it may be a decade or more until cigarettes are non-addictive.  Until then, there will be an effort by the tobacco industry to attract millions of consumers to new, less dangerous, but still addictive tobacco products. 

Republicans Failed Because They Have No Idea What Kind of Health Care They Actually Want

by Robert I. Field

Not so long ago, much of the Republican Party stood united in a vision for health care. For 20 years, Party leaders from across the political spectrum coalesced around elements of a plan that would use the private market to broadly expand coverage.

The plan looked something like this. All Americans would be subject to a mandate to obtain health insurance for themselves and their families or pay a penalty along with their taxes. Most employers would be mandated to offer insurance to their workers. Those without access to employer-sponsored coverage would buy policies on an exchange directly from insurance companies, and insurers would be required to offer coverage regardless of an applicant’s health status. Subsidies would be available for those with low incomes, and those who were very poor would receive coverage under an expanded Medicaid program.

Sound familiar? It is the essence of Romneycare, the health reform plan enacted in Massachusetts in 2006 with the support of Republican governor Mitt Romney.

Romneycare emerged after more than 15 years of Republican efforts to implement such a system. It was originally devised by the Heritage Foundation, a conservative think-tank, in 1989. The concept was supported by 21 Republican senators in 1993, including many moderates, when it formed the basis of the Health Equity and Access Reform Today Act, an alternative to the Clinton plan that was then being debated in Congress.

Heritage encouraged the enactment of Romneycare in 2006 and subsequently touted the plan as a workable solution that should be implemented across the country.

And the concept formed the basis of a plan proposed in 2009 by two conservative Republicans, Representative Paul Ryan and Senator Tom Coburn, the Patients’ Choice Act.

Of course, the Republican market-based plan is also the core of the Affordable Care Act.

What happened when Democrats signed on to the approach? The Republican consensus immediately evaporated. Even Heritage turned against its own handiwork. As soon as the ACA was enacted in 2010, Republicans in Congress announced unbending opposition and began an unrelenting effort to “repeal and replace.”

But seven years later, that promise remains little more than a slogan. Republicans voted more than 60 times to repeal all or part of the ACA while Obama was president, knowing their votes were merely symbolic, since he was certain to veto any legislation that emerged.

And now that they control of both houses of Congress and the White House and have the chance to actually bring a plan to fruition, they can’t figure out what they want.

Republican conservatives want to eliminate any trace of the ACA, even if it means denying lifesaving health care to tens of millions of Americans. Moderates want to insure that whatever form a replacement takes, the ACA’s coverage gains are largely maintained. The Republican health care bill that failed in the Senate this week, the Better Care Reconciliation Act, meets the goals of neither wing.

President Trump can’t seem to decide what he wants, either.  He promised at the start of the presidential campaign that he would not reduce Medicaid spending, but his budget proposal includes major cuts.

The only unifying theme in Republican positions today is a desire to dismantle anything created by President Obama and his Democratic colleagues, even programs based largely on their own principles. That is hardly a vision for constructive public policy.

Crafting a complex government program requires painstaking work, including the arduous task of consensus building. It is not accomplished by hatching a plan through the secret deliberations of 13 senators, as Senate Republicans did in crafting the BCRA, and then rushing it to a vote.

But the laborious work of building programs and forging consensus is the essence of governing. That’s a lesson members of the Republican leadership do not seem to have learned. With their failure, at least so far, to either repeal or replace the ACA, they are now seeing the results.

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Previously posted on the Health Cents blog on Philly.com.