Mid-Year Public Health Policy Update

Ya’ll…the last 4 months have been wild.

Let’s start with the “win”, shall we?

Last week, the Supreme Court of the United States (SOCTUS) issued its ruling in Talevski, authored by Justice Jackson and siding 7-2 in favor of patients’ private right of action to initiate lawsuits when their rights issued by law or regulation relative to a federally funded program are violated by an entity paid under that program. Now, the Taleski family still has to go back to district court to fight the Health and Hospital Corporation of Marion County (HHC) – SCOTUS just denied the effort by HHC to claim patients didn’t have a right to seek remedy when the payor was the government. As we described in January, this idea that patients couldn’t initiate lawsuits when federally funded programs weren’t administered fairly or didn’t comport with the statutory language or regulatory definitions is pretty bonkers. Indeed, for most actions regarding any kind of federally funded programming, the government typically comes in after the fact and those injured have to initiate the court processes themselves. Some advocates, particularly disability and Medicaid advocates, called the potential of the court to rule restrictively in Talevski “the Dobbs of Medicaid”, and urged the parties to consider settling ahead of a ruling. However, the potential crisis was averted because, as Justice Jackson put it, “Hewing to [the relevant statute]’s text and history (not to mention our precedent and constitutional role), we reject HHC’s request, and reaffirm that ‘laws’ in [the statute’s text] means what it says.”

Fancy that, laws meaning what they say.

Speaking of laws and problematic folks tryna skirt them, the 5th Circuit Court of Appeals heard oral arguments as to the stay – not the whole merits of the case – of Judge Reed O’Connor’s effort to strip the Affordable Care Act’s (ACA) preventative coverage mandate by way of extraordinary bigotry – targeting HIV prevention medication because “ewww, the gays”. As our friend, Chris Geidner, over at Law Dork covered those arguments and boy howdy! I wouldn’t wanna be Jonathan Mitchell – well for a lot of reasons but this one is pretty good, too. Mitchell’s name should look familiar as he’s arguing for book bans, helped author Texas’ head-hunting abortion law known as SB8, and is, in general, a deeply rotten human being. During thee oral arguments Mitchell fell more than a little flat, in no small part because the Department of Justice’s attorney, Alisa Klein, was gracious in asking “what’s the harm in putting in a stay?” In essence, she argued the physicians that Mitchell represented – who have themselves claimed to have never personally administered to an abortion or anyone needing HIV-related services but might, maybe, one day have to help a patient who experienced adverse events as a result of these extremely safe medications on the off chance they respond poorly to them – don’t actually have a tangible harm in putting off implementing O’Connor’s “universal remedies”, while some 2 million health plans as an industry and millions of patients across the country certainly will experience an impact if the ruling were to go into effect while being appealed. Mitchell kinda fell flat footed and basically asked the court to speculate what would happen if the stay wasn’t implemented. Hint: Courts aren’t actually supposed to pull conclusions out of thin air, “facts” must be presented inside of defined rules. So Mitchell then hedges cuz everybody suddenly seems real skeptical in how this might relate to standing and he asks of he can maybe meet with the DOJ to come up with some settlement agreement between the parties on the stay.

Now for the not so good news and there’s two bits to this one we’re gonna need to watch for quite some time; 1. Medicaid unwinding and 2. public health funding claw backs in the debt ceiling deal.

Last week, CANN hosted it’s third and final Community Roundtable in a series on COVID-19 impacts on public health and all the bad news is related to that intersection.

Because the House and the Senate voted to end the COVID-19 public health emergency a month early, Medicaid’s continuous coverage unwinding began pretty chaotically. To literally no one’s surprise, millions of folks are already losing their Medicaid coverage and not necessarily because they don’t qualify. The administrative or procedural disenrollments happen not because of a person or family no longer being qualified for Medicaid, but because a program administrator has not received necessary document responses. But the thing about that is, not a whole lot of folks who gained coverage for the first time during COVId-19 actually know a whole lot about the process, according to a Kaiser Family Foundation survey. And not every state is making it easy. Indeed, Arkansas and Florida are in a massive rush to get folks off Medicaid rolls – so fast that advocates are begging those states’ governors to slow down the process in order to reduce the risks of losing people to care who might otherwise qualify. Those states’ governors aren’t likely to respond to these pleas, despite guidance from the Centers for Medicare and Medicaid (CMS) to “not rush” the process. Those disproportionately at risk for being thrown off Medicaid are also those who are most at risk for acquiring HIV or already living with HIV and being covered by Medicaid. Again, about 40% of people living with HIV are covered by Medicaid, it stands to reason our patient population is at risk of potentially falling out of care if these processes are rushed.

Back in April, CANN reviewed annual sexually transmitted infection (STI) surveillance data released by the Centers for Disease Control and Prevention (CDC). In doing so, we pointed out the potential hazards of the Biden Administration failing to uphold its promise to reinvest in public health programming, specifically million dedicated to replenishing the workforce via disease intervention specialists (DIS). Those dollars were promised under the American Rescue Plan (ARP) but, as with all federal programs, take time to disburse. In the case of workforce development in state health departments, that means identifying an appropriate vendor to contract with to provide training, then contracting them to develop a curriculum, then giving guidance as to qualifying certification, then disbursing dollars to contract provider entities, then actually hiring people (in which there’s serious churn), training them, and so on. It takes time. But states weren’t quick to use those dollars and many of them remained unspent as the debt ceiling approached. A late-minute deal was struck between the White House and House Republicans in which certain public health funding allocated under the ARP are being clawed back. How this impacts our nation’s ability to provide meaningful public health services and address rising crises like STIs, we’ll find out in the worst possible way. For what it’s worth, our friends over at the National Coalition of STD Directors has called on the Administration to protect the public health workforce in light of the country’s first STI National Strategic Plan and how cutting those dollars risks any tangible ability to respond.

Advocates have tons more to pay attention to as the Biden Administration begins responding to this state legislative session’s “Hate Slate”, targeting LGBTQ people and our care. And because Congress is working to address things like reforming pharmacy benefit managers and 340B.

In all, advocates should work to focus on their strengths, strengthening relationships with service providers and legislators – sharing the human costs of these moves – and taking care themselves. With so much going on all of the time, we have to celebrate our wins while fighting for a fairer system serving patients. In order to do that, we have to also take care of ourselves.

SCOTUS Sets Dangerous Precedent for Incarcerated People Needing Care

The 8th Amendment to the United States Constitution reads as follows:

“Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”

Long standing precedent, Estelle v. Gamble, sets one standard of “cruel and unusual punishment” as “deliberate indifference” to the medical needs of incarcerated people. Additional precedents include an affirmative need to evaluate these medical needs on an individual basis, cannot be excused as mere neglect when an incarcerated person is at “substantial risk of harm” if that need is not met, and that providing care that is “grossly inadequate as well as by a decision to take an easier but less efficacious course of treatment” are also considered measures of “deliberate indifference”.

In August 2020, the US Court of Appeals for the 6th Circuit added an asterisk: “…if the state decides it can afford to…” provide the care required under the 8th amendment [paraphrasing].

Last month, the Supreme Court of the United States refused to hear the appeal of Atkins v. Parker, where a group of incarcerated people alleged their 8th amendment rights were violated because the state was rationing their HCV related care. In the 6th Circuit appeal, the state argued, successfully, that rationing care was “reasonable” due to budgetary constraints supposedly outside the control of the prison system.

Coverage of both appeals referred to a 2018 settlement in Michigan, wherein the state’s Medicaid program, after suit, expanded coverage to include direct acting agents. However, in a lone descent, Judge Gilman drew more direct parallels in other SCOTUS and 11th Circuit rulings regarding prison overcrowding and access to AZT (case was in 1991) for incarcerated people, ruling in part “The fast moving status of research and medical advances in AIDS treatment is continually redefining what constitutes reasonable treatment.”, respectively. Indeed, in Atkins, the state’s position boils down to “new drugs are too expensive” to be “reasonable” for incarcerated people to have access to. The majority argued because Tennessee’s Department of Corrections Medical Director, Dr. Williams, had only recently restructured the state’s rationing of DAAs and individual assessments, the state had fulfilled its obligations, within budgetary constraints. Judge Gilman correctly argued the state’s medical administrator for the prisons was obligated to request appropriate funding to meet these needs in order to fulfill the state’s 8th amendment requirements – of which, no evidence was presented to prove Dr. Williams did make such a request. Judge Gilman closes the descent with well-established citation that treating HCV early reduces overall costs of care compared to delayed or denied care.

That said, with SCOTUS refusing to hear the appeal, affected people in prisons are facing a dangerous precedent of state officials shirking their Constitutional responsibilities to provide a basic standard of care to the people in their custody. Legislatures merely need to neglect increasing a budget, as we’ve seen in other state-run health care programs, in order to avoid meeting their Constitutional duties.

Interestingly, also in April, the Department of Justice filed a statement of interest in a case in the Georgia, where an incarcerated transgender woman has been subject to violent attacks and refusal of care. The Biden administration’s position here is denying incarcerated people gender affirming medical care is a violation of the 8th amendment’s protections and is thus “deliberate indifference” to the person’s medical needs.

There’s an intersection between Diamond and Atkins that cannot be missed. While the timing of Atkins didn’t favor intervention by the current administration, this administration must also recognize the precedent set forth by Atkins, fight for appropriate funding measures to meet the medical needs of incarcerated people, and update Federal Bureau of Prisons HCV guidance to with regard to prioritization not justifying rationing of care. As with nearly every infectious disease, prisons are both a “canary in the coal mine” of the local community and the ideal environment for manifesting new diagnoses.

The most startling statistic in Atkins is even after DAAs were available, at least 109 incarcerated people had died due to HCV complications. Death by neglect, by rationing is still a death sentence.

Even as I write this, President Biden argued “health care should be a right, not a privilege.”

As it turns out, according to the 6th Circuit, it’s a right, with a large asterisk.

To ensure this injustice is answered for, advocates must remember the courts do not always find justice and our advocacy must reach every level of government. If we don’t, the asterisks will continue to add up.

Novel Developments: Merck & Gilead Partner on New ARVs

On March 15th, 2021, Merck and Gilead Sciences announced a partnership in development of their novel products, Islatravir and Lenacapavir – both currently in clinical trial phases. The partnership isn’t limited to these investigative products – both, if successful, would establish new classes of antiretrovirals each. The agreement allows an option by either manufacturer to investigate potential combination therapies with the other’s already established products. Additionally, while current trials for these medications are focused on oral administration and injectable application, Merck is investigating the potential for Islatravir as PrEP via an annual implant.

Let’s take a moment to acknowledge the remarkable nature of these proposed products. Gilead’s Lenacapavir is aimed at addressing those with multidrug resistance and – here’s the kicker – with a potential to be effective for as long as 6 months via subcutaneous injections. While Merck’s Islatravir has been described as “potent”, it’s so strong that in order for it to be taken once daily, it must be “lightly sprayed” onto a doravirine tablet (the partner medication for Islatrvir in current studies). Which is great for that aim at being a once weekly therapy.

With these two potential first-in-class medications inching closer to the finish line of approval, this partnership also stands to benefit advocates in a another direct way. Merck has been an exceptionally strong advocacy partner, edging into nuanced regulatory territories and working hard to ensure patients lead those discussions and the company’s positions. Gilead is savvy in their marketing, contracting, and programming; from flashy commercials on targeted tv platforms and innovative radio campaigns to the ease in which their products become “preferred” on some formularies to providing 10-day “sample” bottles – which some providers have used to initiate same day treatment for newly diagnosed people living with HIV without ever having to leave the provider’s office.

Merck and Gilead’s partnership here is…interesting to say the least. Prior to January 19, 2021, when the Supreme Court of the United States refused to hear Merck’s appeal, these two pharmaceutical behemoths were engaged in a legal fight over patent rights to hepatitis C medications, Harvoni and Sovaldi, since 2016.

When you work in HIV and Hepatitis patient advocacy, these kinds of things are our soap operas in their own way. We love our contacts within these companies and often share a great deal of our personal lives with them. That type of relationship is tinged, like most familial relationships, when we have conflicts of interest with our friends – where our priorities diverge from those of the corporation’s. The issue of patents and anti-competitive contracting are some of these hot button issues. All of that said, despite the faux-shock theatrics some advocates have used to enjoy the spotlight, our friends in pharmaceutical manufacturing are also some of the strongest supporters of our work (read: the largest share of corporate funding supporting advocacy).

Thankfully, the vast majority of these relationships are dynamic. Advocates enjoy space to call-out practices we find detrimental, direct funding to programs and priorities in alignment with our values, and provide feedback on nuanced areas like clinical designs and regulatory structures. One might say our greatest allies pay us to argue with them. And there’s good logic to such a scheme; a team grows stronger when the weaknesses are evaluated, addressed, and turned into strengths.

Indeed, this partnership, with its expansive nature to include development, manufacturing, and marketing, holds both great promise and great concern for our communities. Gilead is already learning from its failure with Descovy trials to include people assigned female at birth (AFAB) – including cisgender women in clinical trials for Lenacapavir as a long acting injectable (for both treatment and prevention) to begin later this year; though Gilead should note: “people of trans experience” won’t all fit neatly into the clinical trial including cisgender men. To be fair, Merck’s Gardasil commercials still refer to “males and females” rather than the simpler “everyone”.

Sincerely, the trans guy writing this blog.

Taken as a whole, this team poses the potential to be “The Dream Team” in both treatment and prevention and as partners to advocates. We’ll need to see the best of them, not the worst and we’ll need to keep a close eye on how those relationships we’ve come to rely upon may change in light of this new partnership.

In the meantime, (I’m going to say this for the first time a year with a humorous intent rather than a morbid one) pass the popcorn. This season is going to be fantastic!