Gottlieb's threat of federal vaccine mandates: questionable legality, poor policy

By Wendy E. Parmet

As six outbreaks of measles raged in different parts of the country, Food and Drug Administration Commissioner Scott Gottlieb recently told reporters that the failure of some states to narrow vaccine exemptions was “going to force the hand of the federal health agencies.” Without offering many details, Gottlieb added that the federal government “could mandate certain rules about what is and isn’t permissible when it comes to allowing people to have exemptions.”

As someone who has researched and written about public health law, including vaccine mandates, for more than 30 years, I appreciate the sentiments behind Gottlieb’s comments. Vaccines have saved innumerable lives, and have led to the eradication or near eradication of once common scourges, such as smallpox and polio. Vaccine mandates have helped ensure that success by keeping vaccination rates high.

Religious and personal belief exemptions to vaccine laws have done the opposite. They are associated with decreased vaccination rates and increases in vaccine-preventable diseases.

With the number of measles cases rising, especially among unvaccinated children, it makes sense for states to narrow their exemptions, as a bill before the Washington state legislature would do, and as California did in 2015 following a measles outbreak linked to Disneyland. But that doesn’t mean federal health agencies should act as Gottlieb suggests. Doing so would likely violate the law. It could also worsen the problem of vaccination resistance.

First, the law. There is no question that states can require all children (except perhaps those with medical contraindications) to be vaccinated before entering school or day care. In 1905, in Jacobson v. Massachusetts, the U.S. Supreme Court upheld a Massachusetts law that compelled all individuals to be vaccinated against smallpox. In Zucht v. King, the court in 1922 relied on Jacobson to affirm a Texas law mandating vaccination for schoolchildren. Neither the Jacobson nor Zucht cases dealt with claims of religious liberty, since the court had not yet applied the First Amendment right of free exercise against the states, but in a 1944 in a case concerning child labor, the court proclaimed that religious freedom “does not include liberty to expose the community or the child to communicable disease.”

Courts today continue to uphold vaccine mandates, and rule that neither the religious exemptions that 47 states have nor the philosophical exemptions that exist in 17 states are constitutionally required. Paradoxically, state mandates have run afoul of the Constitution only when they contain religious, but not secular, exemptions, or when the religious exemptions favor one faith over another.

That the states are on firm constitutional ground in repealing personal belief or religious exemptions doesn’t mean the federal government can abolish such exemptions. In its 2012 ruling on the Affordable Care Act’s individual mandate, the U.S. Supreme Court said that the federal government’s authority over interstate commerce does not permit it to compel individual action. If Congress can’t require individuals to have health insurance, or eat broccoli, it can’t mandate vaccination either.

Perhaps Gottlieb was suggesting that the federal government could require the states to abolish religious or personal belief exemptions. That would also face significant constitutional problems. Under the 10th Amendment’s anti-commandeering doctrine, the federal government cannot force states to pass laws to its pleasing.

Congress could use its power of the purse to buy state compliance, perhaps by requiring states to get rid of philosophical and religious exemptions in order to receive federal public health funds. But any such conditional spending laws must give states a clear choice and can’t be coercive.

In addition, federal health agencies can’t act without congressional authority. Under current law, the FDA licenses vaccines. But it cannot regulate the practice of medicine, and it has no authority to mandate that individuals be vaccinated. Nor does the FDA have statutory authority to require states to enact specific vaccine laws. The CDC’s Advisory Committee on Immunization Practices (ACIP) is charged with making recommendations about vaccinations, but these are meant to advise, not dictate, state laws.

Nor should Congress give such authority to any federal health agency. Although mandates can save lives, they can also stoke backlashes. Conspiracy theorists already allege a nefarious relationship between vaccine makers and the federal government. These conspiracies have gained traction in part due to the fact that under the National Childhood Vaccine Injury Act, the federal government acts as the defendant in vaccine litigation. Federal mandates could enhance the perception of a conflict of interest, leading more parents to distrust federal officials and question vaccine safety.

The litigation that would almost certainly follow a federal mandate would add to the problem, providing anti-vaxxers with a new forum in which to question vaccine safety as well as the integrity of the federal regulatory process.

As we have seen in California and Washington, infectious disease outbreaks can lead parents and health professionals to work with their state legislatures to narrow or abolish vaccine exemptions. This democratic process, which can occur more organically in the states, helps debunk anti-vaccination misinformation and educates the public about the value and safety of vaccines, as well as the utility of strong state mandates. This process can also provide mandates with the political support and democratic legitimacy they need to succeed.

With measles cases on the rise, it’s no surprise that health officials want to shortcut the often slow and frequently unpredictable democratic process and instead take swift action to reduce exemptions — and increase vaccination rates. Unfortunately, there is no vaccine against vaccine resistance, and constitutionally dubious actions by federal officials can’t do the trick. But by working to improve public education around vaccines, enhancing transparency, educating and paying health professionals to talk to parents about vaccines, and ensuring vaccine safety, federal officials can help bolster trust in vaccines. Those efforts, more than anything, may lead to fewer exemptions.

This article was originally posted on STAT News

Wendy E. Parmet, J.D., is professor of law and director of the Center for Health Policy and Law at Northeastern University School of Law and professor of public policy and urban affairs at Northeastern’s School of Public Policy and Urban Affairs.

Philadelphia’s City Council could have fought opioids by placing limits on pharma reps

By Robert I. Field, Ph.D., J.D., M.P.H.

Does the over-prescribing of opioids lie at the heart of the addiction crisis? Some members of Philadelphia City Council along with many public health experts think so. The Philadelphia City Council recently considered a bill to limit the activities of pharmaceutical sales representatives, also known as detailers, who promote prescription drugs to physicians.

The bill would have required detailers to register with the city for a fee of up to $250, wear identification badges, refrain from giving even small gifts like free lunches to doctors and their staffs, and submit the sales materials they use to the city for review.

Philadelphia is fertile ground for selling pharmaceuticals. It is home to several major academic health systems and physician organizations, and the region contains the headquarters of numerous pharmaceutical and biotechnology companies. It also plays host to a large number of medical conventions that generate business for local restaurants and hotels. Opponents of the bill warned it would have encouraged convention sponsors to look elsewhere, driving away the industry, and the jobs and tax revenue that go with it.

In the end, opponents carried the day, and the bill was defeated by a vote of 9-5.

Would the bill have worked? Recent research suggests that it could have.

A study published in 2017 by researchers at UCLA and Carnegie Mellon examined the effects of limits on drug detailing at 19 academic medical centers around the country. It found that the restrictions resulted in fewer prescriptions for brand-name drugs that detailers promoted. The reduction in prescriptions was modest, but clear.

There is every reason to believe that the proposed limits in Philadelphia would have had a similar effect. And fewer patients receiving prescriptions for opioids could have led to fewer becoming addicted. For a plague as serious as opioid addition, even a small reduction in the number of new victims would prevent a tremendous amount of human suffering, not to mention medical and law enforcement costs that go with it.

With the bill’s defeat, Philadelphia’s risk of losing convention business has faded. At the same time, the opioid epidemic continues unabated. The City is left to wonder which threat is the greatest.

This blog post first appeared in the Health Cents blog on Philly.com.

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About the author: Robert I. Field is a member of the Inquirer’s Health Advisory Panel, and nationally known expert in health care regulation and its role in implementing public policy. He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.

Fact checking Trump's drug pricing claims in the State of the Union

By Brook Baker

President Trump’s State of the Union Address contained a number of distortions, false claims and outright lies regarding drug pricing and access to medicines. Skyrocketing drug prices are a life and death issue for people with HIV in the U.S. and around the world. Here’s a side by side comparison of the facts versus what Trump said. Did we miss any lies? Let us know: admin@healthgap.org

What Trump said:
“The next major priority for me, and for all of us, should be to lower the cost of healthcare and prescription drugs — and to protect patients with pre-existing conditions. Already, as a result of my administration’s efforts, in 2018 drug prices experienced their single largest decline in 46 years.”

Here’s the truth:

Contrary to the President’s State of the Union Address, the list price of monopoly protected  medicines continued to escalate in 2017-2019, with the costs of some of the newest medicines costing hundreds of thousands of dollars a year.  The temporary, minor pause in inflating prices mid-2018 was a publicity stunt by Big Pharma and the President in what has been a relentless drive to maximize profits even if it means payers can’t pay and patients go without.

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What Trump said:
“But we must do more. It is unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong, unfair, and together we can stop it. And we will stop it fast.”

Here’s the truth: 

The U.S. pays more than other countries for medicines because the President and other policymakers do less to restrain excessive pricing than any other country in the world.  They obstruct prices negotiation efforts. They continue to pass laws and enter into trade agreements that strengthen, broaden, and lengthen monopolies on medicines. They don’t seek fair pricing returns on the public’s tax payer investments in pharmaceutical research and development.  What’s wrong and unfair is that the President lets drug companies get away with deadly high prices while he pretends that other countries are doing something wrong by trying to tame unbearable prices.

Low and middle income countries can’t afford the bloated prices that drug companies demand and shame on the President for suggesting that they should.  Those same countries can’t afford the trade agreements and trade threats of the U.S. and Big Pharma that seek to perpetuate and expand global monopolies on medicines.  Drug companies prefer to make high profits off a few rich people even when the vast majority of poor people in other countries are denied access to the fruits of scientific progress.

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What Trump said:
“I am asking the Congress to pass legislation that finally takes on the problem of global freeloading and delivers fairness and price transparency for American patients. Finally. We should also require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs down.”

Here’s the truth:  

Disclosing prices won’t accomplish anything if the untrammeled power to charge whatever the market will bear for life-saving medicines is not addressed.  The freeloading that the President should be concerned about is freeloading by drug companies that harvest innovation done in universities and at the National Institutes of Health and then monopolize the resulting products while they tweak their blockbusters to get new 20 year monopolies for minor tweaks.

Originally posted on the Health Gap blog.

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About the author: Brook Baker is a senior policy analyst for Health GAP (Global Access Project) and is actively engaged in campaigns for universal access to treatment, prevention, and care for people living with HIV/AIDS, especially expanded and improved medical treatment. He is also a professor of law at Northeastern University and an honorary research fellow at the University of KwaZulu Natal in Durban, South Africa.

A caravan of migrants carrying smallpox? We’ve seen that before

by Robert I. Field , professor of law and public health at Drexel University.

              You’ve heard the warnings. Supporters of President Trump’s strict immigration policies are spreading alarm about a caravan of Spanish-speaking migrants bringing deadly diseases to our borders. There are even claims that some of them are carrying smallpox.

             If that were true, it wouldn’t be the first time. Caravans of disease-carrying migrants have reached our borders before, and the devastating effects for public health are well known. They spread measles, typhus, cholera and a host of other lethal infectious conditions in addition to smallpox, causing misery and death for countless native-born Americans.

             The first caravan, this one composed of ships, arrived in 1492 from Spain. Its successful voyage led many others to follow from England, France and other countries in Europe, bringing waves of disease-carrying migrants. Within a few decades, the illnesses they carried had sickened or killed thousands of people.

             The early migrants didn’t know they harbored deadly germs. Most of them had developed immunity from early exposure at home. However, they were highly infectious to those who had never been exposed, like the people who lived in America before they arrived.

             But, there is a big difference between the public health consequences of the migrant caravans of past centuries and the one that recently arrived at the Mexican border. We know with certainty that none of the newcomers has smallpox, because that disease was completely eradicated almost 40 years ago. And there is no evidence that they present any serious disease risk. We also have tools for screening and treating them, if they do.

             Border controls today are, of course, essential for protection against countless risks that open borders could present. But debates over immigration policy should focus on real risks and benefits of immigration, not imaginary ones. The health threats from today’s migrants are nothing compared to those brought by the early European newcomers, some of whom are the forebears of those warning about the risks of immigration today.

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This blog post first appeared in the Health Cents blog on Philly.com.

The Texas ACA ruling is an assault on logic

by Robert I. Field , professor of law and public health at Drexel University.

  ACA opponents have a new approach to attacking the law – incoherence.

 On Friday, a federal judge in Texas accepted the argument of 20 Republican attorney generals that the ACA’s mandate requiring everyone to have insurance is unconstitutional because the tax penalty enforcing it has been repealed. In other words, he struck it down because it no longer has any practical effect. Logic was in for a rough ride in this decision.

 Judge Reed O’Connor relied on the Supreme Court’s 2012 ruling that the mandate’s penalty is constitutional as a tax on those who choose to remain uninsured. But, as part of the 2017 tax bill, Republicans voted to set the amount of the tax at zero. Judge O’Connor concluded that the mandate and the tax penalty are separate, so if the mandate stands on its own and doesn’t trigger the tax, it has lost its constitutional foundation.

 But without the tax, the mandate doesn’t trigger anything. It persists as a directive that everyone have health insurance (with a few exceptions) but with no penalty for failing to comply. It has become a “mandate” in name only.

 Why bother arguing about a now meaningless provision in a much larger law? Because it gave Judge O’Connell a pretext to strike down everything else in the law. He claimed that the mandate, even in its denuded form, remains central to the ACA’s entire legislative scheme - not just to the provisions regulating insurance markets to which it directly relates, but to everything. In legal terms, he found that it is not severable.

 Whether a single provision that is struck down by a court can be severed from the law that contains it is a decision for Congress to make when is enacts legislation. In this case, Congress spoke loud and clear. It repealed the mandate penalty as part of the 2017 tax bill after considering numerous proposals to repeal everything else and enacting none of them. If Congress found the mandate to be as central as Judge O’Connor claims, why would it have approved a proposal to repeal it in isolation?

 The consequences of this bizarre ruling could be devastating. If the entire ACA were to fall, millions of people who obtain coverage through the exchanges would lose it, and those with preexisting medical conditions might never be able to get it back. Millions more who gained coverage through the expansion of Medicaid would lose coverage, as well.

 But that is just the start. The ACA contains hundreds of provisions that have nothing to do with insurance and affect almost every other aspect of the health care system. As a few examples, it enables drug companies to develop and market generic copies of expensive biotechnology drugs known as biosimilars; it rewards hospitals and physicians for forming accountable care organizations that coordinate care to improve efficiency and quality; it improves Medicare drug coverage; and it implements numerous prevention initiatives, like calorie counts on chain restaurant menus.

 By what contortion of logic could the mandate, even if it still had practical effect, be considered central to provisions like these? Clearly, Congress didn’t think so.

 Fortunately, the chaos that would accompany full ACA invalidation is not imminent. Judge O’Connor’s decision will be appealed, and he declined to issue an injunction, at least for now, against enforcement of the law while those proceedings are pending. The Trump administration has said that it considers the law still to be in effect.

 Ultimately, the appeals will likely reach the Supreme Court, which has upheld the ACA twice before. This time, it will have to decide whether a mandate that has been rendered meaningless can be unconstitutional and whether completely unrelated provisions of the law that contains it should be struck down against the clear intent of Congress.

 These are issues more suited to Alice in Wonderland than a legitimate lawsuit. The latest case against the ACA is not just an assault on American health care. It is an assault on logic.

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This blog post first appeared in the Health Cents blog on Philly.com.

Staying in Their Lane: Health Professionals Must Address Gun Violence [from the Hastings Bioethics Forum]

by Patricia Illingworth and Matthew Wynia

In the wake of the recent Twitter fight between the National Rifle Association and U.S. physician groups over whether doctors should speak out about firearm policy issues, we argue that professionalism actually requires that doctors take a leadership role in gun policy debates, even if (in fact, especially if) doing so is politically fraught and financially harmful to them.

The recent publication of a position paper, Reducing Firearm Injuries and Deaths in the United States, by the American College of Physicians prompted the NRA to assert that physician groups should “stay in their lane” and not talk about gun policy issues. So far, the push-back against this admonition has been mostly to emphasize the terrible medical consequences of gun violence, which is appropriate. But medical groups have been mostly silent on the basics of medical ethics and what is required of them as professionals, and that’s an oversight.

Why professions matter today

Translated from Latin, the word “profession” literally means “to speak forth.” So a profession is a group of people who have come together to publicly declare – sometimes even out loud in the form of a creed or an oath – the standards and values that guide their work. This is why new doctors often recite the Hippocratic Oath, and it’s why every profession has a code of ethics. Oaths and codes are ways of speaking forth – professing – what members of the public can expect in terms of skills and attitudes from members of the group. They make up one side of a social contract, in which the members of the profession seek the trust of the public, and all the perks that come with that, in exchange for keeping the promises made in their codes and oaths.

For physicians, their main professional promise is to look out for their patients’ best interests, including putting the health of their patients before their own self-interest. That’s critical for patients, because without the assurance that physicians will always put them first, patients could not, and probably should not, rely on physicians for care when they are at their most vulnerable. For the sick, injured, or dying to place their lives in the hands of a physician, sometimes a stranger, they need to be completely confident that physicians are devoted to patients’ health and well-being and not just looking to enrich themselves.

But there’s more. Upholding professional values isn’t just necessary for strong patient-doctor relationships. It also can help sustain a healthy democracy. Professional values can actually serve as a morally stabilizing force in communities. Truth, trust, the willingness to put the interests of others ahead of one’s own, the impartial treatment of all people without regard to race, culture or income – these are the moral values on which the profession of medicine is grounded, and they happen to be the same moral values necessary to sustain a well-functioning democracy.

Today these values are at risk. Mistrust, xenophobia, hate, bias, partiality, and selfishness sometimes feel like they are becoming new moral norms. Since 2017, trust in government “to do what is right” dropped by 14 percentage points among the general U.S. population. Businesses, NGOs, and the media are experiencing similarly dismal levels of trust, and the Edelmen Trust Barometer is warning of an impending “trust crash.”

Physicians continue to score quite high in public trust, with 65% of U.S. adults saying physicians have “high /very high honesty and ethical standards.” Physicians rank fourth among the most trusted professions, following only nurses, military officers, and grade school teachers. Given the crisis of mistrust all around us today, it is more essential than ever that medical professionals uphold their promises and step up to safeguard the moral norms that our society needs to thrive.

Professionalism demands that doctors speak out

If a profession is a group seeking to earn the public’s trust by openly speaking forth on a set of shared promises, then professionalism is best understood as the belief system (the –ism) underlying these promises. In medicine, professionalism is the notion that society can and should trust medical groups to set and enforce standards of practice and ethical norms, based on their promise that they will always use these prerogatives to help improve the health of the community. In other words, professionalism means that with the privilege of self-regulation comes the responsibility to use medical skills and knowledge to promote public health, even when doing so is politically uncomfortable or financially harmful to doctors.

Obviously, speaking out against the NRA can be politically uncomfortable. But what’s rarely said is this: just as gun manufacturers make money from selling guns, physicians make money from treating the victims of gun violence. Bluntly speaking, that means reducing gun violence would actually be financially harmful for doctors, so the self-serving path would be for medical groups to stay silent and for doctors to just keep getting paid to patch up the people injured and killed in gun violence.

Of course, the idea that physicians would stay silent to prop up high levels of gun violence is ridiculous. After all, doctors would never urge people to keep smoking, drinking, or eating fast food, even though those are good for business too.

But why are these ideas ridiculous? They are ridiculous because we all, deep down, actually believe in physician professionalism, which demands that doctors tackle these issues. If physicians were to remain silent in the face of an epidemic – whether of gun violence or from any other source – it would rightly be interpreted as opportunistic, uncaring, and professionally incompetent. Worse, it would be a blatant breach of doctors’ collective promise to always seek to improve the health of the public, even when it’s not easy and even when it might cost doctors some revenue.

And guns are like smoking, drinking to excess, and eating junk food in more ways than one. For each of these products there are self-serving constituencies, uninterested in the health of the public, who wish doctors would just stop talking about the role of their products in hurting people.

But doctors won’t stop, because speaking out when it is difficult and costly is exactly what makes the profession of medicine worthy of the public’s trust, and thank goodness for that. The willingness of physician groups to speak out on gun policy is critical for public trust in medicine, and today it might also be reinforcing the values that are at the heart of our democracy. It proves that professional norms of truth, trust, impartiality, and placing the interests of others before self are more resilient in the medical profession than some might have realized – and maybe seeing physician groups uphold these values  will help preserve these values among the general population, too.

So, while it might be inconceivable to the leadership of the NRA that  the American College of Physicians and the American Medical Association—which perhaps it regards as mere trade groups — could act against the financial best interests of their constituents, for these medical groups it’s actually business as usual when it comes to public health issues. After all, speaking out on issues like gun violence is what proves medicine really is a profession and not just a trade.

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Patricia Illingworth, JD, PhD, is a professor at Northeastern University and a senior fellow at the Carr Center for Human Rights Policy at the Harvard Kennedy School.

 Matthew Wynia, MD, MPH, is a professor of medicine and director of the Center for Bioethics and Humanities at the University of Colorado, Anschultz Medical Campus. Twitter: @matthewwynia.

This blog post was originally published in the Hastings Bioethics Forum on December 17, 2018.

The Health Impact Of The Proposed Public Charge Rules [from Health Affairs Blog]

by Wendy E. Parmet, Matthews Distinguished University Professor of Law and Faculty Director, Center for Health Policy and Law at Northeastern University School of Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs 

This post was originally published on the Health Affairs blog (Sept. 27, 2018).

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On September 22, the Trump Administration announced it would soon publish in the Federal Register proposed new regulations defining when lawfully present immigrants should be considered a “public charge.” Although the draft regulations posted by the Department of Homeland Security (DHS) were not as far-sweeping as a version that was leaked last winter, if promulgated they would still have a dramatic impact on public health and the health care system.

For over a century, the Immigration and Nationalization Act has required most immigrants (not including refugees, asylees and certain other exempt groups) who seek to enter the United States, and most non-citizens within the United States who want to obtain permanent residency status, to show that they are “not likely to become a public charge.” The Act does not define “public charge,” but under a 1999 guidance, the term has only been applied to non-citizens who rely on cash benefits for most of their income, or to those who require public assistance for long-term care or institutionalization. The receipt of non-cash benefits, including publicly-funded health insurance, does not make one a public charge.

The Administration’s proposed regulations would end those exemptions and redefine “public charge” as including non-citizens who receive an amount greater than 15 % of the Federal Poverty Level (for a household of one) of certain listed monetizable benefits, including Supplemental Security Income (SSI), Temporary Assistance for Needy Families (TANF), the Supplemental Nutrition Assistance Program (SNAP) and federal housing support. In addition, except in limited circumstances, a non-citizen could be considered a public charge for receiving Medicaid or premium and cost-sharing subsidies under Medicare Part D for 12 out of 36 months. Immigrants who use these benefits for fewer months could also be found to be a public charge if they also receive monetizable benefits. The proposal posted by DHS also seeks comments as to whether participation in the Children’s Health Insurance Program (CHIP) could also cause a non-citizen to be found to be a “public charge.”

The draft regulations explain that the public charge determination is one that is future-oriented. The key question is whether the individual, looking at the totality of circumstances, is likely to use any of the covered benefits in the specified amounts in the future. However, use of any of the listed benefits within 36 months of filing for an adjustment of status (though not reaching back before the regulations go into effect) will be treated as heavily weighted negative factors in determining whether an individual is likely to become a public charge by using such benefits in the future.  As a result, an immigrant who was on Medicaid for several years as a child may find that that coverage is held against her if she seeks a green card once she becomes of age, even though her circumstances may have changed dramatically. DHS also proposes to consider whether an immigrant has “private insurance or the financial resources to pay for reasonably foreseeable medical costs related to a medical condition that is likely to require extensive medical treatment or institutionalization “ or will interfere with the immigrant’s ability to care for him or herself or work or attend school.

Negative Health Impacts

If promulgated these changes will almost certainly harm the health of immigrants and their families. Most obviously, the changes will create a significant disincentive for immigrants to enroll in publicly-funded health insurance programs. In its comments, DHS estimates that 2.5 % of the eligible population of immigrants and their family members who are otherwise eligible for Medicaid or Medicare Part D subsidies will either dis-enroll or forego participation in the programs. In reality, many more immigrants, including many who are not actually subject to the public charge requirement because they  have an exempt status, are likely to avoid coverage due to fear of negative immigration consequences. Even before the proposed regulations were posted by DHS, many immigrants chose not to enroll either themselves or their children in public programs because of fear of possible adverse immigration consequences.

The emphasis that DHS seeks to place on immigrants’ medical condition is likely to exacerbate the problem, creating a type of “pre-existing condition” bar for non-citizens. Under the proposal, the absence of private health insurance alongside the existence of a serious medical condition makes an individual more likely to be found to be a public charge. Hence immigrants, especially those without private health insurance, will have a strong incentive to avoid medical examinations and tests, even when offered free of charge, lest a potential health problem be discovered. As a result, treatable medical conditions will remain undiagnosed and untreated until they become emergencies. Ironically, the proposed regulations deal with that by not considering the receipt of so-called emergency Medicaid, which pays for emergency care, in determining whether an individual is a public charge. The regulations thus create a strong incentive for non-citizens to wait until their health problems become emergent.

The impact of the proposed regulations on health, however, extends far beyond the negative consequences that will follow from patients losing their health insurance or avoiding medical care. The inclusion of SNAP and housing subsidies in the list of benefits that can render one a public charge means that many immigrants will avoid critical programs that can improve the social determinants of health. Importantly, the loss of these benefits will inevitably extend beyond non-citizen immigrants to their entire family, including their citizen children. After all, a child will lose access to housing if her immigrant mother avoids housing support.

The proposal’s ripple effects will undoubtedly extend even wider. As DHS notes in its comments, the regulations may increase the financial woes of health care providers who serve immigrant communities, as their patients avoid public insurance and even, potentially, primary care. This financial hardship could well cause some providers to cut back on vital services for their entire community, not simply the non-citizens.

The False Promise Of Universal Self-Sufficiency

Indeed, what is perhaps the most striking about the proposed regulations is the fact DHS recognizes their potential harmful impact. In its comments, the department states that its proposal may lead to:

• Worse health outcomes, including increased prevalence of obesity and malnutrition, especially for pregnant or breastfeeding women, infants, or children, and reduced prescription adherence;

• Increased use of emergency rooms and emergent care as a method of primary health care due to delayed treatment;

• Increased prevalence of communicable diseases, including among members of the U.S. citizen population who are not vaccinated;

• Increases in uncompensated care in which a treatment or service is not paid for by an insurer or patient; and

• Increased rates of poverty and housing instability; and

• Reduced productivity and educational attainment.

Despite acknowledging these drawbacks, DHS claims that the regulations are, nevertheless, necessary to ensure “self-sufficiency” among immigrants. Yet, when it comes to health, the goal of complete self-sufficiency is unrealistic and quixotic. Look across the life span, and it’s easy to recognize that none of us is self-sufficient during our childhood, and few of us will be in the future if we live long enough. And that does not consider the fact that our health is significantly affected by social and environmental factors outside of our control. None of us can be self-sufficient in the face of a widespread epidemic, an environmental catastrophe, or even a motor vehicle accident caused by others. That is just as true for non-citizen immigrants as everyone else. As DHS notes, almost 20 % of American citizens rely on the programs affected.  The demand that immigrants achieve self-sufficiency is implausible. It is also cruelly demeaning to all Americans who rely on the programs that are targeted.

Fortunately, it isn’t too late to prevent the alarming prospects that DHS cites from coming to pass. Once the Regulations are published in the Federal Register, the public will have 60 days to comment. During this period, health care providers, health policy experts, and the public health community will have an opportunity to weigh in. The nation’s health may depend upon their doing so.  

A lethal game of chicken: the next trade war with China could be a matter of life and death

by Robert I. Field , professor of law and public health at Drexel University and founder and editor of the Health Cents blog.

The most important trade war to come may have nothing to do with cars, steel or soybeans. It may involve a virus.

 The vast agricultural enterprise in southern China is the source of most new flu strains. Under rules established by the World Health Organization in 2011, China has routinely shared samples of them with researchers in the United States and other countries where vaccines are developed. But recent trade tensions may be leading it to change course.

             Influenza is a serious disease. The seasonal variety kills thousands of people worldwide each year. But its impact pales in comparison with pandemic flu. That is the kind that emerges every few years and spreads like wildfire around the globe, sometimes killing millions – as it did in 1918.

 Public health officials fear that a new flu pandemic may be on its way. A strain of bird flu known as H7N9 originated among poultry in China in 2013 and evolved into a form that can infect humans. It reportedly kills 40% of those who become ill. It has not yet spread beyond China and is not yet contagious from human to humans, with only about 1,600 reported cases so far. However, should it mutate into a form that can be spread between people, the threat could be worldwide.

 A vaccine against H7N9 could save thousands of lives – maybe millions. However, China is refusing to share virus samples despite repeated requests. It has even refused to share clinical data on infected patients. Information flowed freely soon after the strain first emerged, but it has slowed to a stop. Researchers have obtained a few samples from Taiwan and Hong Kong, but those may not be enough to develop a vaccine.

 China claims that it has almost eradicated the virus with a single poultry vaccination campaign, so further vaccine development is not needed. But public health experts are not reassured, since mutations are always possible.

 This is not the first time China has been secretive about a pandemic threat. In 2002, it hid information on SARS, and in 2005, it hoarded samples of a previous bird flu strain, H5N1. But until recently, it had been cooperating with the World Health Organization’s more recent rules on sharing flu strain samples.

 Why the sudden secretiveness? One possibility is that China is trying to avoid harm to its poultry industry. Another is that it is looking for a head-start over the U.S. and other countries in developing a vaccine on its own.

 However, the is also a strong possibility that it is responding to the brewing trade war with the U.S.

 Among the Chinese experts on which the U.S. has threatened to impose tariffs are pharmaceutical products, including vaccines, and other medical supplies. Virus samples seem to be part of the mix of products over which we are negotiating, even though no one actually owns them so tariffs should not apply. China may be waiting for the outcome of those talks before allowing virus samples out of the country.

 While the United States and China trade tariff threats, the risk grows that we will be unprepared if a pandemic arrives. The fight over bird flu samples is a game of chicken in more ways than one, and it could have lethal consequences.

             International trade is more than just an economic issue, as important as that is. It is also a matter of public health. Unless our trade policy recognizes that as a priority, a lot more may be at stake than the prices we pay for imported goods.

This blog first appeared in the Health Cents blog on Philly.com.

(Image: AP File/Charlie Neibergall)

Public Comment: HHS Proposed Revisions to Title X Funding Regulations

Yesterday, along with the George Consortium and in collaboration with the Center for Health Policy and Law at Northeastern University School of Law, we submitted public comments to the Dept. of Health and Human Services (HHS) regarding proposed revisions to Title X Regulations. We offer a reprint of the comments we submitted. 

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Office of the Assistant Secretary for Health
Office of Population Affairs
Attention: Family Planning
U.S. Department of Health and Human Services
Hubert H. Humphrey Building, Room 716G
200 Independence Avenue SW
Washington, DC 20201

Re: Docket Number: HHS-OS-2018-0008, RIN: 0937-ZA00

Public Comment on Proposal to Revise Title X Regulations, Compliance with Statutory Program Integrity Requirements

Dear Assistant Secretary ADM Brett Giroir, MD:

The Center for Health Policy and Law at Northeastern University School of Law[1] and the Public Health Law Watch (PHLW)[2] appreciate the opportunity to make comments on the proposed Department of Health and Human Services (HHS) revisions to 45 CFR Part 59, “Compliance With Statutory Program Integrity Requirements.” The Center for Health Policy and Law is a university center of excellence focused on providing a rich context for students and researchers interested in myriad health-related topics, including public health law, health and human rights, health governance, bioethics, and drug policy. PHLW is a project of the George Consortium, a nationwide network of public health law scholars, academics, experts, and practitioners. It should be noted that these comments have been prepared by the Center for Health Policy and Law and PHLW, but do not represent the view of Northeastern University School of Law, Northeastern University, or individuals affiliated with either the Center or PHLW.

We offer comments on the proposed regulations’ failure to provide for exemptions or protections for providers whose conscience dictates that they counsel and provide medically-appropriate information about abortion and abortion-related services.

These proposed regulations seek, among other things, to eliminate the current requirement that Title X grantees “offer pregnant women the opportunity to be provided information and counseling regarding… pregnancy termination.”[3] On page 25506,[4] the “supplementary information” section invokes “conscience protections” as one justification for eliminating that provision. Specifically, it reasons that this provision conflicts with statutory “conscience protections” shielding health care personnel from engaging in practices conflicting with their moral and religious values. The commentary posits that eliminating the requirement to give women the opportunity to get information about abortion would solve any potential clashes between that provision and conscience provisions.

This reasoning, however, assumes that moral and religious conviction protections only apply when invoked against abortion. But that is simply not true. Dr. Willie Parker, for example, describes his mission to provide women with abortions as a Christian imperative.[5] Refusing to do so, he reasons, would be akin to the biblical Samaritan who refused to help a fallen traveler. An interfaith coalition blesses clinics that provide abortion for upholding the values of autonomy.[6] The late Dr. George Tiller, who was murdered in his church by an anti-abortion extremist, described his work of providing abortions as “a ministry.”[7] Others view providing abortions as a moral duty[8] to provide needed care to women who need help.[9] Some providers and health care workers believe their conscience requires adherence to professional and medical ethics, which require health professionals to provide all relevant, medically-appropriate information to patients, including when patients ask for a full range of family planning and/or abortion-related options and referrals, and when medically-appropriate even in the absence of explicit requests for such information or referrals by the patient.[10]

These proposed regulations change not only disregard the interests and rights of providers and patients whose consciences support ensuring transparency around and access to information related to abortion and abortion-related services, referrals, and counseling, they also ignore the fact that federal law protects the conscience of such providers. On page 25512,[11] the supplementary information section invokes the Church Amendments (codified at 42 U.S.C. 300a-7)[12] by describing its discrimination protections for health care professionals who refuse to perform abortions.  The notice for proposed rulemaking, however, fails to include, even in its footnoted quote of the law,[13] the provisions in the Church Amendments that explicitly also protect the professionals who do perform abortions, as well as those who counsel and/or refer patients to abortion services.[14] The law equally protects those with “reluctance or willingness to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to or consistent with the applicant’s religious beliefs or moral convictions.”[15] The law recognizes that “religious beliefs or moral convictions” are not homogenous and do not operate solely in one direction. To be consistent with this provision of the law, as well as with the Department’s proposed conscience regulations[16], the Proposed Title X regulations should allow for health care providers whose conscience compels them to provide patients with full and medically-relevant information about their reproductive health options, including by providing them with clear and useful referrals to abortion services and providers, even in instances when patients do not explicitly request such referrals.

Sincerely,

Center for Health Policy and Law
Northeastern University School of Law
lawhealth@northeastern.edu  

Public Health Law Watch
phlawwatch@northeastern.edu  

[1] Center for Health Policy and Law, https://www.northeastern.edu/law/health.

[2] Public Health Law Watch, https://www.publichealthlawwatch.org/.

[3] 42 CFR § 59.5(a)(5)(C) (2017).

[4] Compliance with Statutory Program Integrity Requirements, 83 Fed. Reg. 25502 (proposed June 1, 2018) (to be codified at 42 C.F.R. pt. 59).

[5] Stephanie Russell-Kraft, Reclaiming the Moral Imperative for Reproductive Choice. A Q&A with Dr. Willie Parker., The Progressive (Apr. 11, 2017), http://progressive.org/dispatches/reclaiming-the-moral-imperative-for-reproductive-choice.

[6] Caroline Kent, The Religious Coalition Blessing Abortion Clinics Across America, Broadly (May 10, 2018, 10:15 AM), https://broadly.vice.com/en_us/article/a3azz4/religious-coalition-reproductive-choice-abortion-clinic-blessing.

[7] Carole Joffe, Working with Dr. Tiller: Staff Recollections of Women’s Health Care Services of Wichita, 43 Persp. On Sexual And Reprod. Health 199-204 (2011).

[8] Elizabeth Reiner Platt, Many Doctors are Motivated by Their Moral and Religious Beliefs to Provide Abortions. Why Doesn’t HHS Care About Their Consciences?, Public Rights/Private Conscience Project Blog (Mar. 29, 2018), , http://blogs.law.columbia.edu/publicrightsprivateconscience/2018/03/29/hhsconscience/.

[9] Holly Fernandez Lynch & Ronit Y. Stahl, Protecting Conscientious Providers of Health Care, N.Y. Times, (Jan. 26, 2018), https://www.nytimes.com/2018/01/26/opinion/protecting-conscientious-providers-of-health-care.html.

[10] See American Medical Association, Physician Exercise of Conscience, AMA Principles of Medical Ethics, I, II, IV, VI, VIII, IX (2016), https://www.ama-assn.org/delivering-care/ama-principles-medical-ethics. See also American Academy of Physician Assistants, Guidelines for Ethical Conduct for the PA Profession (2013), https://www.aapa.org/wp-content/uploads/2017/02/16-EthicalConduct.pdf .

[11] Compliance with Statutory Program Integrity Requirements, supra note 4.

[12] See 42 U.S.C. §300a-7 (2016).

[13] Compliance with Statutory Program Integrity Requirements, supra note 4.

[14] See 42 U.S.C. §300a-7(c) and (e). See supra note 12.

[15] Id.

[16] Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, 83 Fed. Reg. 3880 (proposed Jan. 26, 2018) (to be codified at 45 C.F.R. pt. 88).

Reports on the Opioid Crisis are Full of Misidentified Problems and Poorly Calibrated Solutions [from Bill of Health]

In April, our Center for Health Policy and Law hosted a two-day conference entitled "Diseases of Despair: The Role of Policy and Law." Our friends at Harvard Law School's Petrie-Flom Center is now hosting a blog symposium from that conference on Bill of Health. 

The third piece is from Professor Nicolas P. Terry.  For the full post, please visit Bill of Health.  

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The epidemic associated with Opioid Use Disorder (OUD) has birthed a proliferation of reports, many with notable provenance. They include the Surgeon General’s Report(2016), the President’s Commission on Combating Drug Addiction and the Opioid Crisis(2017),  and the National Governors Association Recommendations for Federal Action to End the Nation’s Opioid Crisis (2018). We can add innumerable regional and statereports to that list.

Placed next to each other, their recommendations are broadly similar. While they may differ somewhat to the extent that they emphasize criminalization versus medicalization, overall, they tend to coalesce around harm reduction (such as broad naloxone availability and syringe exchanges), upstream opioid reduction strategies (such as prescription limits and prescription drug monitoring programs), and increased public health surveillance based on improved data collection and analysis.

Most reports endorse healthcare and public health initiatives such as broader availability of all three types of FDA-approved medication-assisted treatment (MAT) in multiple treatment settings, including jails, as well as the provision of wrap-around services, and tackling social determinants of health.

However, these proposals often are more diffuse, the strategies unclear, and the funding (if any) of dubious sustainability.  

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Please visit Bill of Health for the remaining full article