Webinar: ACA Under Threat: The Potential Impacts of Repealing the Affordable Care Act

What would happen to the health of millions of Americans if the Affordable Care Act were to go away? How would some of the most vulnerable populations and those on Medicaid be affected? In this webinar hosted by Public Health Law Watch and the Network for Public Health Law, experts on the ACA will consider the upcoming 5th U.S. Circuit Court of Appeals’ decision on the constitutionality of the ACA and the impacts were it to be repealed.

Register

By attending this webinar, you will:

• Hear a summary of the legal issues in the case, including the Department of Justice’s decision not to defend the individual mandate or any other provision of the ACA

• See how the current case relates to previous cases and judicial opinions on the ACA

• Learn how the ACA’s provisions have impacted health care access and coverage for women, racial minorities, and transgender individuals

• Learn how aspects of the ACA, including Section 1557, coverage of essential health benefits, elimination of gender rating, and Medicaid expansion have helped vulnerable populations

Moderator:

• Faith Khalik, Legal Fellow, Northeastern University School of Law

Presenters:

• Elizabeth Weeks, Associate Dean for Faculty Development & J. Alton Hosch Professor of Law, University of Georgia School of Law

• Sarah Somers, Managing Attorney, Network for Public Health Law and National Health Law Program

• Seema Mohapatra, Associate Professor of Law and Dean’s Fellow, Indiana University Robert H. McKinney School of Law

You may qualify for CLE credit. ASLME is an approved provider of continuing legal education credits in several states ASLME will also apply for CLE credits in other states upon request. An email from ASLME regarding CLE credits will be sent to attendees following the webinar.

Trump administration rule would undo healthcare protections for LGBTQ patients

By Emmarie Huetteman

A new Trump administration proposal would change the civil rights rules dictating whether providers must care for patients who are transgender or have had an abortion. Supporters of the approach say it protects the freedom of conscience, but opponents say it encourages discrimination.

The sweeping proposal has implications for all Americans, though, because the Department of Health and Human Services seeks to change how far civil rights protections extend and how those protections are enforced.

Roger Severino, the director of the HHS Office for Civil Rights, has been candid about his intentions to overturn an Obama-era rule that prohibited discrimination based on gender identity and termination of a pregnancy. In 2016, while at the conservative Heritage Foundation, he co-authored a paper arguing the restrictions threaten the independence of physicians to follow their religious or moral beliefs.

His office unveiled the proposed rule on May 24, when many people were focused on the start of the long Memorial Day holiday weekend.

The rule is the latest Trump administration proposal to strip protections for transgender Americans, coming the same week another directive was proposed by the Department of Housing and Urban Development that would allow homeless shelters to turn away people based on their gender identity.

The public was given 60 days to comment on the HHS proposal. Here’s a rundown of what you need to know about it.

What would this proposal do?

Fundamentally, the proposed rule would overturn a previous rule that forbids health care providers who receive federal funding from discriminating against patients on the basis of their gender identity or whether they have terminated a pregnancy.

The Trump administration proposal would eliminate those protections, enabling providers to deny these groups care or insurance coverage without having to pay a fine or suffer other federal consequences.

That may mean refusing a transgender patient mental health care or gender-confirming surgery. But it may also mean denying patients care that has nothing to do with gender identity, such as a regular office visit for a bad cold or ongoing treatment for chronic conditions like diabetes.

“What it does, from a very practical point of view, is that it empowers bad actors to be bad actors,” Mara Keisling, executive director of the National Center for Transgender Equality, told reporters.

The proposal would also eliminate protections based on sexual orientation and gender identity from several other health care regulations, like non-discrimination guidelines for the health care insurance marketplaces.

Does it affect only LGBTQ people?

The proposal goes beyond removing protections for the LGBTQ community and those who have had an abortion.

It appears to weaken other protections, such as those based on race or age, by limiting who must abide by the rules. The Trump proposal would scrap the Obama-era rule’s broad definition of which providers can be punished by federal health officials for discrimination, a complicated change critics have said could ease requirements for insurance companies, for instance, as well as the agency itself.

And the proposal erases many of the enforcement procedures outlined in the earlier rule, including its explicit ban on intimidation or retaliation. It also delegates to Severino, as the office’s director, full enforcement authority when it comes to things like opening investigations into complaints lodged under the non-discrimination rule.

Why did HHS decide to change the rule?

The Obama and Trump administrations have different opinions about whether a health care provider should be able to refuse service to patients because they are transgender or have had an abortion.

It all goes back to a section in the Affordable Care Act barring discrimination on the basis of race, color, national origin, age, disability or sex. President Barack Obama’s health officials said it is discrimination to treat someone differently based on gender identity or stereotypes.

It was the first time Americans who are transgender were protected from discrimination in health care.

But President Donald Trump’s health officials said that definition of sex discrimination misinterprets civil rights laws, particularly a religious freedom law used to shield providers who object to performing certain procedures, such as abortions, or treating certain patients because they conflict with their religious convictions.

“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” Severino said in a statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives.”

Much of what the Office for Civil Rights has done under Severino’s leadership is to emphasize and strengthen so-called conscience protections for health care providers, many of which existed well before Trump was sworn in. Last year, Severino unveiled a Conscience and Religious Freedom Division, and his office recently finalized another rule detailing those protections and their enforcement.

The office also said the proposed rule would save about $3.6 billion over five years. Most of that would come from eliminating requirements for providers to post notices about discrimination, as well as other measures that cater to those with disabilities and limited English proficiency.

The rule would also save providers money that might instead be spent handling grievances from those no longer protected.

The office “considers this a benefit of the rule,” said Katie Keith, co-founder of Out2Enroll, an organization that helps the LGBTQ community obtain health insurance. “Organizations will have lower labor costs and lower litigation costs because they will no longer have to process grievances or defend against lawsuits brought by transgender people.”

Why does this matter?

Research shows the LGBTQ community faces greater health challenges and higher rates of illness than other groups, making access to equitable treatment in health care all the more important.

Discrimination, from the misuse of pronouns to denials of care, is “commonplace” for transgender patients, according to a 2011 report by advocacy groups. The report found that 28% of the 6,450 transgender and gender non-conforming people interviewed said they had experienced verbal harassment in a health care setting, while 19% said they had been refused care due to their gender identity.

The report said 28% had postponed seeking medical attention when they were sick or injured because of discrimination.

Critics fear the rule would muddy the waters, giving patients less clarity on what is and is not permissible and how to get help when they have been the victims of discrimination.

Jocelyn Samuels, the Obama administration official who oversaw the implementation of the Obama-era rule, said that for now, even though the Trump administration’s HHS will not pursue complaints against those providers, Americans still have the right to challenge this treatment in court. Multiple courts have said the prohibition on sex discrimination includes gender identity.

“The administration should be in the business of expanding access to health care and health coverage,” Samuels told reporters on a conference call after the rule’s release. “And my fear is that this rule does just the opposite.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Opioid litigation updates

Opioid Multi-District Litigation (MDL)

Over 1,500 federal court cases have been consolidated into the opiate multi-district litigation in the Northern District of Ohio. Cities, counties, tribes, hospitals, and others are suing opioid makers and distributors in the MDL overseen by Judge Dan Aaron Polster. During the MDL’s first hearing in January 2018, Judge Polster said he wanted a settlement within a year. The bellwether cases, Cuyahoga County, Ohio v. Purdue Pharma and Summit County, Ohio v. Purdue Pharma are slated to begin trial on October 21, 2019.

State Lawsuits

At least 39 states have filed lawsuits against Purdue Pharma, seeking to hold them responsible for their role in the opioid addiction and overdose crisis. A few notable cases:

• Oklahoma

  • In March 2019, Purdue Pharma settled its case with Oklahoma for $270 million. According to the settlement, $102.5 million will go to establish a national addiction treatment and research center at Oklahoma State University, with an additional $15 million per year for five years; $20 million will go to addiction treatment and overdose reversal medications; $12.5 million will go to help cities and counties with the opioid crisis.

  • On May 26, 2019, Teva announced a settlement with Oklahoma for $85 million.

  • On May 28, 2019, the nation’s first opioid trial began, as Oklahoma lawyers accused Johnson & Johnson of oversupplying its drugs and misrepresenting the safety of opioids.

• North Dakota

  • On May 10, 2019, a district judge dismissed North Dakota’s suit against Purdue Pharma, reasoning the company does not have control over the drug after it enters the market. The state has said they will appeal the dismissal.

PHLW files amicus brief in opiate MDL

By Faith Khalik, Legal Fellow at Public Health Law Watch at Northeastern Univ. School of Law

On May 3, 2019, Public Health Law Watch and six other amici filed an amicus brief in the national prescription opiate litigation in the northern district of Ohio.

During the case’s first hearing in January 2018, Judge Dan Aaron Polster told lawyers that he expected to see a settlement that would reduce the adverse public health impact of the opioid crisis, instead of just “moving money around.” The amicus brief submitted by PHLW et al. proposes just that: a settlement that includes a framework for addressing the opioid crisis and has a meaningful positive impact on public health.

Specifically, the brief proposes the creation of a nonprofit foundation to monitor the settlement’s implementation, participate in development and implementation of evidence-based programmatic initiatives, and administer funding for local treatment and prevention resources.

Amici believe that establishing such a foundation would result in better public health outcomes, as it would ensure that settlement funds go directly toward public health interventions and related initiatives, rather than being redirected toward non-health related priorities the plaintiffs may have. This was an important lesson learned from the 1998 tobacco Master Settlement Agreement (MSA). As discussed in the amicus brief, one of the major failings of the MSA was the fact that it mostly moved money from the defendants to the plaintiffs without any requirement for the funds to address public health issues resulting from tobacco use. Although the plaintiffs in the MSA initially stated their intent was to use the settlement funds for public health purposes, other budgetary needs competed for priority and won; in 2019, states will collect over $27 billion from MSA proceeds and tobacco taxes but allocate only 2.4% of that income to tobacco prevention and related efforts.

Despite this gap in the settlement’s design, the foundation created by the MSA (truth initiative, formerly American Legacy Foundation) is regarded as a public health success. Researchers have concluded that truth’s counter-marketing campaign accounted for a significant decline in youth smoking prevalence.

Based on combined decades of research, subject-matter expertise, and lessons learned from the MSA, amici proffer an outline for a similarly-structured foundation to combat the opioid crisis.

It could be argued that due to differences between tobacco and opioids, a specialized foundation is even more necessary for the opiate litigation than it was for the MSA. Differences include that a) tobacco use is always harmful, while opioid use constitutes an important health care tool; b) the harms from tobacco were caused mainly by defendant’s own products, while there is a large, uncontrolled market for illicit opioids; c) price increases in tobacco directly increased costs to individual users, reducing consumption, while price increases in opioids would likely increase costs to insurance companies, plaintiffs, and the federal government. Because of these differences, a more nuanced approach is necessary in this case.

To remediate the crisis, any approach must factor in four issues. First, it must improve access to evidence-based addiction and overdose treatment, including medication-assisted treatment and overdose reversal drugs. Second, it must improve access to effective pain management. Third, it must address the root causes of substance use and overdose, and refer back to them when constructing and implementing its plan. Finally, it should publicize defendants’ internal documents. The approach should allow for adaptability as further evidence on approach efficacy accumulates.

Poorly calibrated responses that have slashed access to prescription opioids have in some cases exacerbated the problem they were attempting to fix. A nonprofit foundation developed and led by those with public health expertise, specifically opioid use disorder expertise, would be best positioned to navigate these and other issues.

 (Amici include The Center for Public Health Law Research at Temple University, ChangeLab Solutions, Health in Justice Action Lab, The Network for Public Health Law, Northeastern University’s Center for Health Policy and Law, and The Public Health Advocacy Institute)

______________________________

Faith is the Legal Fellow responsible for overseeing the Public Health Law Watch, a collaborative initiative between the Center for Health Policy and Law and the George Consortium, a network of academics, scholars, and practitioners in the field of public health law. 

Experts discuss mitochondrial replacement therapy and the future of U.S. policy

By Nirban Bhatia

Last month, The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School organized a panel of academics from around the globe to present their research and perspectives on mitochondrial replacement therapy (MRT), a highly controversial treatment that is currently prohibited in the United States.

The MRT process takes healthy mitochondria from a donor’s egg and then replaces its nucleus with the mother’s nucleus. This procedure is primarily done so women with mutant mitochondrial DNA can have biological children without any mitochondrial disease. Mitochondrial disease is known to cause serious issues such as oxygen deprivation, which can leave people bed-ridden or in a wheelchair with severe impairments. While this treatment serves as a great solution for a number of women, experts are not entirely sold on its benefits.  

Each individual panelist was allotted a brief amount of time to highlight the major findings from their work. While the content during the first half of the presentations revolved around the in-depth biology of MRT and the various techniques used, the conversation steadily transitioned into a more interdisciplinary realm, ultimately concluding with a social and bioethical lens on the issue.

Currently, MRT is banned in the United States due to unresolved debates about the value of the procedure versus the ethical issues it presents. In terms of public opinion, a study conducted by medical faculty at Columbia University found that 90% of women interested in having children would undergo MRT to have a child. Although there is public support, the relatively niche use of MRT seems to explain why it has not been a significant priority for our nation.

Multiple panelists made references to the United Kingdom, which unlike the United States, allows MRT if a given clinic has a special license and a patient is approved by a review board.

While a UK-based model would be difficult to emulate due to the fragmented health care system in the United States, there are also significant philosophical roadblocks in the U.S. As discussed by Dr. César Palacios-González, a Fellow at The Oxford Uehiro Centre for Practical Ethics, many are concerned that MRTs will pave the way for the increased use of other gene-editing technologies such as CRISPR. Additionally, some critics believe the approval of the unborn child would be necessary to ethically use MRT.

In contrast, supporters believe that barring MRT in the United States infringes upon reproductive freedom, an issue that is consistently brought up in health policy discussions. Many claim their moral and fundamental right to undergo whatever procedures they desire, especially if the procedure can improve health outcomes for many children annually.

Although this panel discussion did not result in any decisions or outcomes, it laid out a highly informative and thorough landscape of the MRT dispute currently troubling policymakers in the United States. You can watch the full discussion here.

EDGI: EPA didn't provide enough information for true public comment on WOTUS rule

On February 14th, the EPA and Engineers Corps published a new rule changing the definition of “waters of the United States.” The public could comment on the new rule until April 15th. However, it’s unclear whether the public had access to enough information to make a truly informed comment.

In its public comment, the Environmental Data & Governance Initiative (EDGI) argued the EPA did not provide sufficient resources to allow for authentic public comment on the new rule.

According to EDGI, resources previously available on the EPA website containing information on the relevant underlying science were later removed. “The EPA’s website is intended to be a trusted and easily accessible resource,” EDGI wrote. “However, beginning in May 2017, resources that the EPA formerly posted about aquatic ecosystems and the Clean Water Act itself were made less accessible, and in many cases, removed entirely.” Removed resources included introductory materials on aquatic systems, links to research reviews that support the current Rule, and pages in Spanish.

The Clean Water Act only protects waters designated “waters of the United States” (WOTUS). Under the new rule, many wetlands would not be included as WOTUS, and thus not subject to Clean Water Act protections. According to the U.S. Geological Survey, an estimated 18% of streams and 51% of wetlands would not be protected under the new rule.

“The two most important things the public needs in order to provide informed comments about the proposed WOTUS redefinition are a clear comparison of which streams and wetlands are protected under the 2015 Clean Water Rule versus which would be protected under the new Rule, and the scientific evidence supporting that change,” EDGI wrote. “Neither of these needed resources are provided.”

You can read EDGI’s full comment here.

Join us this week at NUSL's Annual Health Law Conference!

We’ve really been looking forward to this timely and relevant conference at Northeastern’s Center for Health Policy and Law. We hope to see you there!

From the NUSL website:

PROMISES AND PERILS OF EMERGING HEALTH INNOVATIONS

Thursday, April 11 and Friday, April 12, 2019
Northeastern University 

Health care is rapidly changing. Over the last decade, striking innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, have been developed as new entities and modes of delivery, from accountable care organizations (ACOs) to retail minute-clinics, have entered the market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

>> Download the flyer

Throughout the two-day conference, interdisciplinary experts, policymakers, academics, and providers will attempt to answer myriad questions, including:

What are the legal, policy, and ethical considerations regarding new health technologies? New forms of organization?
What safety and privacy issues will arise from new health technologies? How will this change over time?
What protections can we put into place to protect privacy as the market changes and technologies evolve?
Who is ultimately accountable for the development, use, and oversight of emerging health technologies and innovations?
What legal mechanisms exist for promoting access to and serving underserved populations?
Should new innovations focus on clinical health care, population health, public health, or some combination?
Whom do these new technologies and entities ultimately serve (providers, patients, private companies) and how does that lens impact how we incorporate them into the health care system?

The conference is free and open to the public! 

Trump returns Obamacare to the crosshairs and we are all in peril

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

The Trump administration has returned with renewed vigor to its war against the Affordable Care Act. If the attack succeeds, the damage would touch almost all of us.

The latest line of attack is to side with the plaintiffs in a lawsuit challenging the law, who are urging an appeals court to strike down the entire ACA as unconstitutional. Originally, the administration had argued that only the protections for individuals with preexisting medical conditions should be tossed out.

This latest step is highly unusual. It ignores the time-honored bipartisan practice of presidential administrations to defend federal laws against legal challenges, even laws with which they disagree. It is rarer still for an administration to actively side with a challenge. And it is extraordinary for one to harden its position while a challenge is proceeding.

If the administration’s new stance prevails, almost everyone would feel the catastrophic effects. Its original position was destructive enough in pulling health insurance from millions of people who are sick. Its new position would wreak havoc throughout most of American health care.

Among the biggest losers would be millions of adult children kicked off their parents’ coverage, hundreds of hospital partnerships known as accountable care organizations forced to close, millions of seniors again facing the infamous doughnut hole in Medicare prescription coverage, and thousands of patients unable to buy cheaper generic versions of expensive specialty drugs. And, of course, millions of poor and disabled patients who would lose access to health care in states that expanded Medicaid.

All of this comes after the ACA has achieved remarkable success in reducing the number of uninsured, its popularity is at near record levels, and it has strengthened much of the health care industry.

The administration’s action doesn’t even have a coherent legal rationale. Its new argument defies both law and logic.

The argument goes that because the Supreme Court upheld the law’s mandate to obtain insurance as a tax, repeal of the tax by Congress in 2017 eliminated its constitutional basis. And because the mandate is central to the law’s overall scheme, it cannot be severed from the other provisions and everything must go.

This argument makes little sense. The Supreme Court ruled that as a tax, individuals are in full compliance whether they choose to pay the tax or to obtain coverage. With the amount of the tax now set at zero, everyone has automatically complied. In other words, the mandate as a compulsion to obtain coverage has disappeared. How can it be unconstitutional if it no longer exists?

Even if the now nonexistent mandate were found to be unconstitutional, Congress has expressed a clear desire to retain the rest of the law without it. Just a few months before voting to eliminate the tax, it rejected proposals to repeal the law in its entirety. If it had wanted all of the law to fall, it would have voted in favor of full repeal, not against it. In fact, the ACA’s insurance exchanges are continuing to function quite well without the mandate, providing coverage to millions of people.

Even if the mandate were found to be essential to the insurance coverage provisions, it is clearly not central to many of the law’s other elements that have nothing to do with insurance. How, for example, is it central to requiring calorie counts on restaurant menus?

Might anyone benefit from the new assault on the ACA? It’s hard to image who they would be.

Certainly not the millions of patients who would lose access to health coverage and pay higher prices for drugs. And certainly not the hospitals whose partnerships to improve the quality and efficiency of care would dissolve, the insurance companies that would see markets for individual policies disappear, or the drug companies whose generic specialty drugs could no longer be sold.

And probably not Trump’s fellow Republicans, who could face voters next year as the anti-health care party.

Trump can’t seem to keep the ACA out of his crosshairs, and his scorched earth policy could burn everyone. He might not care, but millions of Americans should.

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

_______________________________

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.

PHLW hosts comment writing party at Northeastern Law

Last week, Public Health Law Watch hosted a comment writing party at Northeastern Law, with help from the Center for Health Policy and Law and How To Get It Done.

Eighteen students showed up to write comments regarding the USDA’s proposed SNAP rule that will likely take food stamps away from over 700,000 people.

We provided students with fact sheets, comment templates, copies of the proposed rule, and of course, snacks.

After the success of this event, PHLW is considering hosting multi-campus comment writing parties in the future. Contact us if your law school or organization would be interested in participating!

New SNAP rule further limits food benefits for unemployed and underemployed people

By Faith Khalik

On February 1, 2019, the USDA published its proposed rule to further limit food benefits for unemployed and underemployed people.

Typically, an able-bodied adult without dependents (ABAWD) can receive Supplemental Nutrition Assistance Program (SNAP) benefits for only 3 months every 3 years, unless they are working, volunteering, or in job training at least 80 hours per month.

States can receive waivers to extend SNAP eligibility for ABAWDs living in areas with high unemployment rates, or with a “lack of sufficient jobs.” Currently, an area qualifies as having a “lack of sufficient jobs” if the unemployment rate is at least 20% higher than the national average. States can combine contiguous areas together and use the average to qualify for a waiver.

The proposed rule creates stricter standards for what constitutes an area having “lack of sufficient jobs,” with the goal of reducing the number of ABAWDs able to receive SNAP waivers. It prohibits waivers for areas with unemployment below 7% and also limits states’ flexibility to combine areas.

Currently, 56% of ABAWDs are subject to the 3 month limit. With the 7% floor in place, 89% of ABAWDs would need to find sufficient work or lose their benefits.

According to the USDA, the rule would take SNAP benefits away from 755,000 people. However, that number assumes the rule would boost work compliance rates from 26% to 33%. If work rates stayed the same, 850,000 people would lose food stamps.

Madison Hardee, a policy analyst and attorney at CLASP, is concerned about the disproportionate effect the rule will have on communities of color. Hardee says discrimination and structural barriers to employment drive higher rates of food insecurity in Black and Latino households. “The most effective way to help people thrive is by addressing existing disparities, not reducing waivers,” she said.

The USDA admits the rule has the potential to harm minority groups, but has not yet stated any mitigation strategies to lessen the impact.

________________________________

Click here to submit a formal comment on the rule.

Comment templates can be found here, here and here.