House Appropriations Mark-Up Alarms HIV Advocates
On July 14th, the U.S House of Representatives Committee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) issued its fiscal year (FY) 2024 appropriations mark-up (Editor’s Note: the mark-up hearing can be viewed here). The bill passed out of committee on a party line vote, with Republicans voting in favor and Democrats voting against. The party split reflects what Democrats have framed as bad faith undermining of agreements on spending levels made in May’s debt limit ceiling deal and include policy provisions geared toward stoking a “culture” war. While the leading issue is incredibly steep cuts to public health programs, including entirely eliminating funding for the previous administration’s Ending the HIV Epidemic initiative (which the Biden Administration wished to continue), the policy riders at issue would also undermine best practices for achieving our public health goals by limiting the types of care, education, and support services communities accessing HIV services might be able to access.
Brass tax, Committee proposed:
Ending the HIV Epidemic eliminated (-$524M)
Ryan White HIV/AIDS Program reduced (-$74M, eliminates dental coverage and AIDS Education Training Centers [AETCs], as included in Part F)
Minority AIDS Initiative reduced (-$32M)
Substance Abuse Mental Services Administration – MAI eliminated (-$117M)
Flat funding for the Centers for Disease Control and Prevention’s HIV and HCV prevention programs
Flat funding for other parts of the Ryan White HIV/AIDS Program, particularly for AIDS Drug Assistance Programs (ADAPs)
Non-HIV related cuts seek to further defund public education and the National Institutes of Health and eliminate Title X and Teen Pregnancy Prevention Programs, the federal work-study program, among other things.
HIV advocates across the country decried the bill, including but not limited to The AIDS Institute, HIV + Hepatitis Institute, AIDS United, the National Association of State and Territorial AIDS Directors (NASTAD), and the National Minority AIDS Council. Southern AIDS Coalition (SAC) has organized a letter for individual advocates and organizations to sign-on. The letter is addressed to Senators Tammy Baldwin and Shelly Moore Capito. Astute observers already recognize this appropriation will not survive the Senate as drafted by the House.
Earlier this year, HIV media outlet The Body called these efforts out for what they are and by title “HIV is Being Swept Up in the Anti-Woke Agenda”. Mandisa Moore-ONeal, Executive Director of the Center for HIV Law and Policy (CHLP), drew a direct link between behavior seen earlier this year in Tennessee as a forebearer of federal moves, “Can’t help but think back to all those…who dismissed us when we said to notice these state funding cuts and to start moving against them but told us again and again ‘It’s just the South’.” The Centers for Disease Control & Prevention’s landing page for regional analysis on HIV identifies that 51% of new HIV diagnoses are among Southerners.
Politically, Southern states are often dismissed by politicians (and advocates) not from here because some of the country’s most conservative strategies are developed in the South. However, the racial diversity of the South is also the reason progressive advocates need to focus on the region. That same diversity is precisely why the nation’s civil rights battles started here and why the forefront of combatting the domestic HIV epidemic, be it advocacy, services, or policy, must be focused here.
The Community Access National Network has already joined our colleagues in signing-on and condemning these cuts which, if enacted would not only bring a halt toward our progress in combatting HIV and other public health concerns, but would signal a dramatic step back and make our goals impossible to achieve. The House’s appropriation amounts and the policy riders included are not only mean-spirited, political jockeying of resources the most vulnerable communities in the country rely upon, they are staggeringly dangerous.
New CDC Report; More than a Decade After a Cure, HepC Persists
Last year, the Centers for Disease Control and Prevention (CDC) published a Vital Signs report detailing how “too few people” are being “treated for Hepatitis C” (subtitled: “Reducing Barriers Can Increase Treatment and Save Lives”). Today, the CDC’s landing page reflects a finding from April 2020 that reads “dramatic increases in Hepatitis C” (subtitled: “CDC now recommends hepatitis C testing for all adults”). And in late June, the CDC published a new Morbidity and Mortality Weekly Report (MMWR) on a worryingly low rate of HCV clearance in the United States.
Our previous blog reviewed last year’s report under the lens of health disparities highlighted by researchers’ review of 48,000 patient charts that met the inclusion criteria for the analysis. Then, much like in this new report, identified that lack of curative treatment access was not uniform and was largely informed by the type of insurance patients qualified for. Those payer types (Medicaid, Medicare, and Commercial plans) also represent patients from different backgrounds – meaning different socio-economic statuses, different genders and racial backgrounds – with different outcomes. Overall, Medicaid recipients were only ever prescribed curative treatment about 23% of the time, whereas Commercial payer patients were able to see that rate increase to 35%. The CDC also recognized these payers, and the politicians who set the public policy of Medicaid, represent incredibly tangible barriers via administrative processes, like prior authorization, and policy barriers, like requiring sobriety, a high level of liver damage, or other restrictions to gaining access to curative treatments.
For this year’s report, researchers partnered with Quest Diagnostics to review the viral clearance (or cure) of approximately 1 million patients with an initial infection (Quest provided data for 1.7 million patients with evidence of a history of HCV during the direct acting agents era, or from January 1, 2013 – December 31, 2022). Based on an estimated 2.4 million people in the United States with HCV, this sample represents about 43% of those believed to have experienced an HCV infection in this time frame. This is noted as a limitation in the data, in part, because it only represents data from one commercial laboratory. Though, reasonable observers can make certain conclusions from this data.
Now, we should also note, only about 88% of the 1.7 million patients identified as having evidence of HCV infection ever had received testing and, of those, 69% were identified as having an initial infection. This means the majority of patients identified were newly diagnosed and not facing a chronic HCV infection. Of those, about 7% of patients showed evidence of viral persistence.
Authors note “These findings reveal substantial missed opportunities to diagnose, treat, and prevent Hepatitis C in the United States.”
Coverage was highest among those enrolled in commercial insurance (50%) and lowest in Medicare and Medicaid (8% and 9%, respectively). Particularly startling in the differences between payer types was the prevalence of viral testing; those with an unspecified payor type were screened at about 79% and those with commercial insurance or Medicare had a testing prevalence of about 91%.
Patients with “other”, “unspecified”, or Medicaid as their insurance or payer had showed a lower viral clearance rate (23%, 33% and 31% respectively) than their counterparts enrolled in Medicare or commercial plans (40% and 45%, respectively). Overall, the cure rate was about 34%.
The age range with the highest rate of HCV diagnoses was 40-59 years, representing about 43% of the patient records reviewed. 60% were identified in their charts as male. However, the highest rate of viral clearance was among those aged over 60 and the lowest was for those aged between 20-29 years.
Other limitations to the data include a lack of uniformity in the follow-up period between testing, which might lead to some difference in rates. Similarly, patients might use or be referred to a different lab for follow-ups. Though, the data also does not follow patients and would not capture any representation of subsequent reinfection and cannot make any assumptions as to clearance or viral persistence among those who did not have RNA testing (and referral for treatment) – meaning the data likely underestimates the patients in each of these categories.
Advocates can look toward these data and findings to inform necessary policy changes, particularly by payer type and in seeking appropriate provider activation on screening and treatment. The sheer reality is HCV is both preventable and curable and policymakers and payers need to work more efficiently in order to prevent the approximate 14,000 HCV related deaths this country faces annually.
Analysis: Biden’s Budget Request Emphasizes HIV, HCV Goals
On March 9th, President Joe Biden released his proposed budget. As with all Presidents, in all years, and in all sorts of political climates, it outlines what can generously be called a “wish list”. Rarely, even under unified control of the government, does a President’s budget request get a full match. Most often, the budget Congress passes and the budget a President proposes are dramatically different. In 2022 (and in decades past), Biden attributed a quote to his father: “Don’t tell me what you value. Show me your budget – and I’ll show you what you value.” To that end, Biden’s budget proposal has a few notable areas of interest with regard to HIV, hepatitis C, public health in general, and with regard to priorities that might affect various stakeholders along the chain from manufacturing medications to patients.
In a call to advocates, just prior to the full court press release of the President’s budget, White House staff touted a proposed expansion of the Inflation Reduction Act’s (IRA) drug price negotiation provisions to include more medications up for government control of list prices as part of a “savings” counterbalance to expenditures in the proposed budget. It’s important to note no specific medications have yet been proposed under the IRA, any proposed “savings” the government expects to see have not been tested, and, yet again, these potential “savings” are not required to be passed down to patients or even back to the government as a public sponsor of affected plans. Similarly, on the call, officials said the proposed budget would stop “subsidizing” pharmaceutical manufacturers and, immediately thereafter, stated a priority in the budget would be to incentivize innovation as part of the administration’s “Cancer Moonshot”.
There are several HIV-related provisions in the budget request as well. First up, the proposal seeks to expand funding for the Ending the HIV Epidemic initiative started under the previous administration by about $313 million. These dollars would be bolstered by a $90 million increase for HIV prevention activities at the Centers for Disease Control and Prevention (CDC) and a $15 million increase for associated CDC programming around pre-exposure prophylaxis (PrEP) for the prevention of HIV. Notably, these same funds are a portion of dollars Tennessee will be rejecting later this year. Right along with these increases, Biden’s budget seeks to increase Ryan White HIV/AIDS Program funding by $125 million in order to better ensure those already living with HIV have better access to care and treatment.
One of the crowning jewels of the request includes funding for a national PrEP program to the tune of $9.7 billion over 10 years. That particular request may get passed and have some funding, but it is not likely to be funded at this level…or anywhere near sufficiently to meet the need. As it stands, relatively few people who would benefit from PrEP are taking the medication and that number, based on preliminary data for 2022, might be falling again. Largely, PrEP is being used by white men who have sex with men, who are already highly activated, while fewer Black Women and Black men who have sex with men are accessing the medication. A national program may help on this front, but only if it’s handled correctly and carefully. To that end, the CDC has been making a concerted effort to urge primary care providers to adjust their comfort level with prescribing PrEP and having conversations with patients about their sexual activities.
The proposal, however, did not include an increase in funding for Housing Opportunities for People with AIDS (HOPWA), a particular priority of advocates.
Biden’s proposal also includes an increase in funding for the Indian Health Service to better address HIV and Hepatitis C by about $5 million.
In line with these efforts, the Administration unveiled the financial cost of a national Hepatitis Elimination Program (HEP): $11 billion (over 10 years). Now, effort has been in the works for a while, benefitting from a boost of interest from advisor Francis Collins. Biden’s team is already working hard blunt the shock of the request, arguing that making the investment now would, in that same timeframe, actually only amount to about $5.2 billion, thanks to savings realized by a reduction of costs associated with treating long-term impacts of Hepatitis C, including certain cancers. The program would aim to save 100,000 lives by 2050, if goals are achieved.
Of these ideas, HEP likely has the best chance of getting closer to its goal (though, not nearly as close as the Administration or advocates might like), in part, because the idea is largely modeled after cost savings realized in Louisiana and Washington after implementing a “subscription” model of drug purchasing for public programs. While these programs have indeed saved monies for those states, and would do so for the country at large, and increased the number of people accessing curative direct acting agents, they have also stagnated in reaching their goals. That lack of progress after making a giant leap can be attributed to several factors, of which both Ending the HIV Epidemic and a national Hepatitis Elimination Program will face.
Let’s break those factors down real quick by highlighting the Hepatitis C program, which focuses on medication cost and access among at-risk communities near exclusively.
A report from the CDC released last year found just 1 in 3 insured patients who need access to curative treatment for Hepatitis C received it. These are patients whose coverage is already guaranteed. Barriers included payer administrative burdens, including prior authorization requirements, and, likely most importantly, providers just not…providing; not screening, not referring patients for diagnostic testing, not prescribing curative medications for patients (hoping the virus will clear on its own), and not following up to ensure sustained virologic response. And that’s for well connected and engaged patients. Hepatitis C thrives among populations which are routinely hardly reached – people who use drugs, poorer populations, imprisoned people, persons experiencing homelessness, a whole host of folks who need a whole awful lot of help. While the Administration’s proposals would look at encouraging using local pharmacies as points of access and investing in innovative screening tools, like rapid tests, none of those things speak to identifying and treating people most affected by Hepatitis C and HIV. And none of those things would incentivize private providers to increase their frequency of screening for and treating Hepatitis C and HIV.
These lofty goals are admirable. And frankly, they’re achievable. We would also need these tools already mentioned, certainly. But without baseline investments in making HIV and Hepatitis C screening a standard of care, a mandatory inclusion in annual wellness checks, requiring prisons and jails to screen, report to state health departments, and provide curative care on both intake and release, without ensuring clinics are sufficiently funded to have staff to do street outreach, we’re gonna keep missing the mark. Reaching communities that are hardly reached means spending more money per patient in order to reach each patient, not less.
So yes, this is a great start. Yes, these investments need to be made. Yes, this is a great starting point. No, it’s not enough.
Advocates would be well-served to fine tune messaging that thanks allies in power for supporting these tools while also emphasizing that we haven’t yet used all of the tools still in our toolbox. We need to continually re-invest in the foundation of this work while also growing and innovating. Medication is but one tool and without the support for patients to even get to a provider who is willing to screen and treat them, all the medication in the world won’t help.
We need to invest in our own “Yes, and…show me your values…” as we meet with each other, our partners, law makers, policy makers, and the Administration.
HCV ‘Netflix’ Model Reveals Price Isn’t the Biggest Problem
A recent article published to STAT News offers a detailed view on how in 2019, Louisiana and Washington State invested in the headline making, flashy deal of the century. It involved an unlimited supply of direct acting agents (DAAs) known to cure Hepatitis C (HCV) for the price of a standard “subscription” fee. Now, it wasn’t a $9.99 per month, endless video watching gig, but rather thousands of prescription fills per month meant to address the needs of each state’s Medicaid program and correctional facilities. However, such penned deals are estimated to have already saved the two states hundreds of millions of dollars. The subscription model is exciting, STAT reports the Biden Administration wants to build a similar program on the federal level. So that should solve the problem, right?
Not so fast! The data, and the experts, offer a more cautious tone.
A heady launch led to incarcerated people, who had previously sued for access to these curative treatments, finally received them. The states moved to reduce the “utilization” restrictions, like prior authorizations or requirements to have a specialist supervise the care. But that steady progress slowed to a trickle, and signs exist that the progress is already being lost.
2020 brought well-known disruptions in care, including reductions in screenings in hospital settings, and strained prison and jail staffing. And while the COVID-19 pandemic’s crisis phase may provide somewhat of a pass, it doesn’t explain all of the losses and slow return to focus on each state’s plan to eliminate HCV.
What’s at the core of the elimination efforts missing their mark? The planning and implementation of the program hinged on the idea that drug cost was the primary issue as to why people weren’t accessing this curative treatment. Turns out, even if the drug is free to patients and affordable for states, there’s more to care than cost, especially in public health. Despite hundreds of millions in saved dollars, neither state set aside enough (or any) of those projected savings to bolster provider education, invest in the human capital necessary in health care entities serving the most affected public (like federally qualified health centers), or reimbursement for “street medicine”, or innovative program designs, or – as especially is the case in Louisiana – ensuring state health departments have the staff dedicated toward HCV elimination.
Let us take a second to consider that last point. Louisiana’s STI, HIV, and Hepatitis Program is in pretty desperate shape. A long list of job openings reflects the fact that much of the program’s staff are subcontractors with those contracts spread across three different entities, a result supposedly of former Governor Bobby Jindal’s efforts to gut the program entirely, the program can’t attract or retain talent because wages remain ridiculously uncompetitive and, in instances where staff is offered promotions, they have to consider the trade off of losing their health benefits and accrued vacation days for a short period of time if that position is being held under one of the other three contracts. With that kind of tangled web to navigate, no wonder the state is falling behind. On social media, some state legislators have openly mocked the Louisiana Department of Health asking for budget increases. None of that touches the lack of physical access points of care patients need in more rural parts of the state – sometimes driving hours to find a provider to treat their HCV – or the failure of jails and hospitals to universally implement the screening elements of a successful elimination plan.
With the Biden Administration already struggling to get Congress to fund similar subscription plans for COVID-19 testing and treatment and flat out refusal from certain Senators to fund the Centers for Disease Control and Prevention’s sexually transmitted infections work despite data showing that under no uncertain terms the need exists, is there any real hope an appetite exists for similar funding to eliminate HCV in the United States?
One thing is clear, the cost of medication a payer sees (public or private) is not the biggest barrier to care for patients. Indeed, few patients care very much at all about what a payer’s costs are – patients care what their costs are and that includes costs not readily recognized by payers (like costs associated with time off work due to narrowed provider networks), or the time it takes providers to build trust in highly affected, highly marginalized communities. In fact, if policymakers wish to make the great investments necessary to eliminating HCV, they can start with sensible steps like requiring and enforcing hospitals to implement opt-out screening activities by way of rule making or legislation directing HCV screening to be a standard of care and integrated into the state’s essential health benefits benchmarks. Similarly, those same policymakers could require and enforce implementation of universal screening in all carceral settings or introduce legislation which requires departments of corrections to provide DAA to all incarcerated people diagnosed with HCV, regardless of cirrhosis status. States could require commercial health plans to cover DAAs at no cost sharing or require that all covered entities in that state charge a flat dispensing fee for DAAs (recognizing abusive dispensing fees for DAAs necessarily reduce the dollars available to support public health programming). States could dig into consolidation of access points to care to the exclusion of entire geographies hard hit by disparities.
There’s so much more to “access” to care than what a payer negotiates with a drug manufacturer and focusing exclusively on the issue of drug pricing. Without robust planning, reinvestment of “savings” into the logistical supports – including competitive wages and benefits packages for labor needs – necessary to feed the roots of this tree, all we’ll be left with is the low hanging fruit and rotten wood. And if we’re not careful, efforts at Ending the HIV Epidemic might end up looking much the same.
Blame Payers for Only 1:3 Patients Receiving HCV Cure
On August 9th, the Centers for Disease Control and Prevention (CDC) provided an early release of a Morbidity and Mortality Weekly Report (MMWR), detailing the massive inequity between insured patients in need of curative Hepatitis C (HCV) treatment. By evaluating the HealthVerity claims and encounters database, researchers were able to identify particular patient characteristics, including payer type (private, Medicaid, and Medicare), sex, race, and age. Of particular note, assessment included recognition of various restrictions some state Medicaid programs impose on patients.
Importantly, the CDC notes that about 2.2 million people in the United States are living with an HCV diagnosis and 14,000 people die of HCV-related conditions annually. These deaths are largely preventable thanks to the development of curative treatments through direct acting agents (DAA)s. The analysis also cites previous research finding that providing timely, curative HCV care reduces costs to payers (and their sponsors) compared to costs of denying care. This remains true even when patients experience reinfection or treatment interruptions. Essentially, a cornerstone of public health is affirmed in curing patients of HCV, patient quality of life and health, engagement in society, and the economic benefits thereof are well-served when patients have ready access to life-saving treatment. This all emphasizes why the disparities displayed in the findings of this report are unacceptable and must be addressed with urgency.
Generally, for inclusion in the analysis, patients needed to be enrolled in health insurance coverage consistently just before and during the time period used in the paper. Of the unique patient files evaluated, just under 48,000 qualified for inclusion in this analysis. Medicaid and patients with private insurance saw about the same number of HCV screenings performed, however, Medicaid patients were more than twice as likely to receive an HCV RNA test whereas Medicare patients were most likely to receive an HCV RNA test than the other two payer types with rate of HCV positivity was highest among Medicaid patients. Of Medicaid patients qualified, more patients lived in states with treatment restrictions (47%) than in states without restrictions (38.8%). Overall, patients enrolled in private care were most likely to initiate DAA treatment inside of the following year (35%) and Medicaid patients were the least likely (23%). Treatment initiation was most likely to occur within 6 months of diagnosis. Critically, there did not seem to be a massive racial disparity within a particular payer type, except those patients who selected “other” or were missing racial information in their claim. For Medicaid patients, the drop was significant (19% and 20% respectively). Patients enrolled in Medicaid in states with program restrictions were 23% less likely to initiate treatment than Medicaid patients in states without restrictions.
The authors urge some caution because the qualification for inclusion required a long period of continuous insurance enrollment and did not include uninsured, incarcerated people, or people who receive coverage through other public payers (Veterans Administration or AIDS Drug Assistance Programs). The CDC expects treatment initiation for people who experience disruption in insurance coverage are less likely to initiate curative HCV treatment, in general. And the data provided has no ability to inform the “why” behind delays in initiation or failure to initiate curative treatment.
The data did not mention how the COVID-19 pandemic may have affected claims, treatment initiation, screening and testing, or even insurance enrollment during the period of time included in the assessment.
The Center for Health Law and Policy Innovation at Harvard and the National Viral Hepatitis Roundtable issued a lengthy statement urging policymakers to take note of the report. The groups highlighted their annual report on barriers to care in state Medicaid programs, Hepatitis C: State of Medicaid Access, pointing toward to work as a guidepost for reducing barriers to care and increasing patient access. The report has recently undergone an update in metrics assessed as progress has been made on fronts regarding issues raised in previous reports. Notably, the updated metrics include an “other restrictions” category to include restrictions on treating reinfections, requirements in on medication adherence (including adherence to medications not used to treat HCV), and refusal to cover lost o stolen medications. That last piece needs note because the state of Florida is one of those (9 in total) programs which limit coverage for lost and stolen medications and these barriers, under issues of natural disasters, institute yet one more barrier to care and burden when patients can afford disruption the least – such disruptions also impact adherence, creating what can amount to an unwinnable situation for many Medicaid patients.
Significantly, the CDC’s report opens with noting that all of this is preventable. Advocates should consider pressing this report with their federal and state electeds and policymakers, emphasizing these findings represent the “best” of circumstances, in terms of coverage, and many of their constituents (and ours) do not enjoy the best circumstances.
Treatment Restrictions Hampering Hep C Harm Reduction Efforts
In January, Harvard’s Center for Health Law and Policy Innovation (CHLPI) and the National Viral Hepatitis Roundtable (NVHR) issued their 7th update to the Hepatitis C: State of Medicaid Access report. Originally published in 2017, the report seeks to evaluate and document the nuances of Hepatitis C treatment access in state Medicaid programs and was borne out of the payer originated barriers instituted after curative direct acting agents (DAAs) came to market as concerns over cost rose, especially in light of the fact that a patient being cured does not mean they cannot be re-infected and the most at-risk population for contracting HCV are drug users. The combination of moralized policy making and fiscal fears set the stage for Medicaid to offer curative HCV treatments as a “yes, but…” situation.
Medicaid coverage of treatment came with layers of restrictions on patients and providers alike. From more common utilization management practices, like prior authorizations, to restrictions in who can access treatments (sobriety and fibrosis requirements) and requiring patients to visit a specialist in order to receive coverage (when a primary care physician should be able to manage the necessary care), barriers abound. Harm reduction advocates rightly pointed out refusing treatment coverage worked against best practices in interrupting HCV chains of transmission. Indeed, the American Association for the Study of Liver Diseases has strongly discouraged sobriety requirements because doing so artificially inserts barriers to care and harms public health efforts to eliminate HCV, stating:
… there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, miss an opportunity to decrease HCV transmission, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Instead, scaling up HCV treatment in PWID is necessary to positively impact the HCV epidemic in the US and globally.
The pushback against the moralized argument, which frames drug users as “unworthy” of receiving potentially life-saving care, is that people who use drugs are still patients and we don’t get to tell patients how to prioritize their care based on a payer or provider’s biases. Just as providing gender affirming care results in improved health outcomes in transgender people living with HIV, providing people who use drugs with the medical care they need to cure HCV improve the behavioral health factors that contributed to drug use in the first place.
CHLPI and NVHR’s work has contributed to awareness of these policy issues, with the updated report being used as an effective tool in advocacy for removing these unethical restrictions on accessing HCV treatments. Since the 2017 report, 33 states have eliminated or reduced their fibrosis requirements, 29 states have eliminated or significantly relaxed their sobriety requirements, and 28 states have reduced their qualifying prescriber requirements.
Similar qualitative evaluation of other “harm reduction” policies, should be done to consider how these policies may potentially work against the goals of why they were instituted in the first place; including but not limited to Good Samaritan laws (where carve outs for those reporting over doses may result in the reporter being charged with a crime, rather than protected for seeking help) and “lock-in” laws and policies (where a patient may not be allowed to seek a different pharmacy or provider). In each of the two examples, people who use drugs are discouraged from engaging with public service personnel by disempowerment and threat of criminalization, risking either losing a patient in care or losing a life.
The mark of quality policy making, much like the mark of good science, is being willing and able to consider changing things when the facts of a given situation change or the available information changes. If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what’s working and what’s not. And we have to learn not to repeat our mistakes in the coverage restrictions finally falling out of favor.
Jen’s Half Cents: Supporting Patients by Supporting Families and Survivors of Intimate Partner Abuse
I’m a family man. I always have been. I tend to write in the evenings or at night and I like to do so sitting in bed. As I write this, my partner has dozed off next to me and her children are sleeping down the hall after a busy day of school and family time. I’m thinking about one colleague who had a health scare over the last couple of days (he’ll be ok) and the depth of emotion between worry and love is something that I can near physically feel. My sense of family is strong and the relationships I consider familial extend to a very select group of colleagues in the space of patient advocacy. I’ve often cited that sense of family as part of what keeps me happy in this work. That love is one I am fortunate to have and it’s something I like to remind folks of from time to time, in part, because this work is hard and paying witness to struggles comes with its own emotional toll and reminding colleagues we are driven to this work from a sense of justice and love is often…refreshing, reinvigorating.
A few years ago, at one of ADAP Advocacy Association’s first Fireside Chats, one of my most favorite industry partners, and one of the most brilliant people I’ve had the pleasure of knowing, raised the issue of intersections between the dual epidemics of HIV and substance use. Particularly, she focused on needing to raise awareness of long-term risks for those experiencing non-fatal overdoses, those intersections with infectious disease, and how public health programming would be better served with a more holistic approach to patient care, rather than the often-segmented or siloed environment we still have today. While more syringe services programs are adopting HIV and Hepatitis C testing and linkage to care activities and more HIV programs are offering more competent care for substance users, especially around medication assisted treatment, outside of these activities, there’s little being done to ease the high burden on patients to coordinate their own care across multiple providers or entities. National strategies and funding certainly prioritize referrals, but referrals aren’t the same as successful linkage, successful linkage isn’t the same as retention in care, and at the point of patient experience and meeting public health goals, those distinctions are important. I am of the somewhat unpopular opinion among some recipients and subrecipients that program metrics and grant awards should reflect these differences but that’s for another discussion.
My friend would move the discussion forward by talking about how powerful and moving testimony and advocacy from affected mothers and families, targeting these voices for education on the intersection of infectious disease and substance use, building coalitions would serve to advance the interests of both of these patient communities and especially so for patients living at the intersection of these conditions. As I was meeting with her in December of this year, I had to tell her, “I think about this conversation a lot.” And I do. Years later, this conversation pops up in my mind as I think about patient stories and priorities, different data about isolation as a predictor of substance use or how social supports are clear indicators in successful retention in care and viral suppression. We dedicate a massive chunk of behavioral health resources to ensuring patients have social supports precisely because having those supports is such a strong indicator of successful care. I often find myself thinking about the role families play in being a primary source of social support for many people, how ever we define family for ourselves. I think about this role of family when I assess intimate partner abuse data or read about how mothers experience legal abuse as a form of coercive control in custody situations. I think about it anytime we approach the issue of caregiver supports. I certainly thought about it last year when I wrote about how family courts and child welfare agencies are missed opportunities for linkage to care. I thought about the role of family and that conversation when a former co-worker was being stalked by the father of child at work and the employer failed to support or protect her. I thought about that conversation when recently asked to provide input on an academic institution’s midwifery committee and when a couple we’re friends with announced they’re going to start working to have another baby. I think about that conversation at every headline involving COVID and kids and how the financial supports extended in 2020 and 2021 reduced child poverty. I thought about that conversation while listening to a constituent impact panel on HIV criminalization in the state of Louisiana, how much patients rely on their families to advocate, navigate, support, and love them through what ever health challenges they may be facing. I think about that conversation when considering my own end of life planning and what I want for my family.
I found myself thinking again about that conversation and the need to better support families through public policy as one of many vehicles necessary for addressing the needs of people living with HIV, eliminating Hepatitis C, and tackling the substance use epidemic. I thought about that conversation last week as a bipartisan group of Senators introduced the Violence Against Women Reauthorization Act of 2022, after 3 years of failing to advance a reauthorization. As I read through the bill, I was happy to see funding for marginalized populations, including at-risk populations in Alaska and LGBTQI+ communities. I was happy to see Senators invest funding in directing a federal study on how parents alleging intimate partner violence are likely to lose primary custody over their children, already knowing how abusers leverage family court processes as a means of post-separation abuse is well-documented. I was happy to find a similar study on the association between intimate partner violence and substance use, specifically, how intimate partner violence increases the risk of substance use. I was disappointed to see a failure to more directly require family courts to be educated as to these issues because regardless of those study outcomes, families are weakened when abusers are able to leverage divorce proceedings as a means of further abusing their victims.
I think about all of these things when I think about what our advocate partners and funders are willing to take up as an issue worthy of their labor and dollars. While “mission creep” and maximizing our limited resources are certainly issues patient advocates and our funders must balance, we also have a moral and ethical calling to consider how those whose interests we seek to represent must also be represented holistically in the actions we take. More directly, those providers, patient advocates, and our funders should work to support public policies aimed at strengthening families and ending intimate partner violence on national and state levels. Today, we can do so by vocally supporting the long-overdue reauthorization of VAWA.
Where Public and Private Payers Fail, Patient Assistance Programs Step In
During Community Access National Network’s Co-Infection Annual Monitoring Report, hosted during this year’s SYNC Conference, in reviewing Hepatitis C (HCV) treatment coverages offered by state Medicaid and State AIDS Drug Assistance Programs (ADAPs), I stated “ADAPs play a critical role even in Medicaid expansion states. With the cost of medications for both HIV and HCV, even making just about the Medicaid threshold can create a catastrophic gap in patient financial stability. Given the distinct exposure risks shared for both disease states, ADAP advocates should consider the advantages of their programs to fill this need.” And…
Earlier this year, I wrote a guest blog for ADAP Advocacy Association regarding the funding situation for Georgia’s AIDS Drug Assistance Program in light of shortfalls due to COVID-19. While Georgia has since enjoyed the benefit of astounding state advocates’ work, a hole in the program remains. At the bottom of Georgia’s most recent ADAP formulary a notice reads as follows: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.” Georgia wasn’t the only state to consider ceasing coverage of HCV medications, Texas did as well, though Texas has since added a single direct acting agent back into their ADAP formulary. In discussing the state’s funding shortfalls earlier this year, state representatives mentioned to providers referral to patient assistance programs in order to meet patients’ needs.
The summation here is publicly funded programs are not always aptly designed to meet the needs of vulnerable populations. Indeed, Harvard’s Center for Health Law and Policy outlines barriers to care instituted by public payers, like ADAPs and Medicaid programs, in an annual report. These barriers largely mirror the barriers to care instituted by private payers, wherein private payers argue these are necessary “cost containment” measures (otherwise referred to as “utilization management”). However, for patients, these “cost containment” measures largely amount to “care containment” measures and, frankly, do little more than push patients out of care through administrative burdens, commonly manifested as lengthy appeals processes or requirements for sobriety.
When public and private payers fail patients by refusing coverage of HCV treatments, they also fail our public health goals, perpetuating preventable illness and death. In the space where payers deny coverage and where people cannot afford coverage due to premiums or deductibles or being too high or where patients simply can’t afford insurance coverage and can’t access public programs, patient assistance programs step in. Patient assistance programs may be run and funded by medication manufacturers or by community-based funding programs and navigation information tools.
CANN’s quarterly Co-Infection Watch monitors HCV specific patient assistance programs for status and limits, in order to make identifying resources easy for patients and advocates reviewing the report.
While these tools are excellent tools of last-resort, they are limited and cannot be used as a substitute to sufficient public funding, regulation or legislation ensuring non-discriminatory plan designs, and adequate patient protections. Public payers have come a long way in abandoning caustic programmatic barriers for patients to jump through in order to access care and medication and private players have much farther to go. Regardless of circumstance, neglecting this critical medical intersection by way of foregoing HCV medication coverage is a public health and public payer program failure. All it does is kick a snowball down a hill. We’re already set to fail meeting our 2030 goals toward HCV elimination. We must do better to ensure this problem, at the very least, doesn’t grow.
HIV & Covid-19: A Story of Concurrent Pandemics
On September 20th, Johns Hopkins’ COVID data tracker totaled the “confirmed” (note: not “official”) number of deaths from COVID-19 in the United States to surpass 675,000 – or the estimated number of deaths in the US due to the 1918-1919 H1N1 influenza pandemic (colloquially called the “Spanish flu” because Spanish media were more willing to discuss the pandemic than most other countries). Forbes, STAT, and other large news outlets ran headlines like “Covid-19 overtakes 1918 Spanish flu as deadliest disease in American history” or included statements in their articles like “It was the most deadly pandemic in U.S. history until Monday, when confirmed coronavirus deaths overtook the death toll for the Spanish Flu.”
Which, as Peter Staley pointed out, isn’t factually accurate.
Image: Twitter.com - @peterstaley (Sep 20, 2021) “Um, HIV/AIDS? 700,000 U.S. deaths (and counting), according to the http://HIV.gov https://hiv.gov/federal-response/ending-the-hiv-epidemic/overview”
Staley would quickly admit COVID-19 would or already has likely overcome the death toll of HIV in the United States. While I agree with this analysis, I would add “for now”.
The very nature of HIV has made finding a “cure” or vaccine for the virus an oft sought after “holy grail” in pharmaceutical development. While that grail may have been snatched away by the attention COVID-19 is justly generating, this isn’t the first concurrent pandemic HIV has run alongside. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) both refer to the H1N1 influenza outbreak of the 2009-2010 flue season a “pandemic”. The problem of course isn’t just how deadly COVID-19 is, its’ how botched the domestic and global responses have been to the disease.
Viruses, after all, are opportunistic. They have a singular purpose: reproduce. As such, viruses thrive in environments – ecosystems, if you will – that are sorely neglected, lack coordinated responses, and are largely inequitable. But we knew that. We’ve known that with regard to global and domestic health disparities data for decades. As with personal health, emerging, urgent issues in public health reduce our capacity to address existing issues effectively.
As I mentioned in previous blogs, and has been recently noted by the Global Fund, COVID-19 has drastically reduced the efficacy of existing HIV, HCV, STI, and SUD programs. Even still, Global Fund’s report proves a rather interesting point – when meeting the demands of advocates for programs to provide patients with multi-month supplies of medications, meeting people in their own neighborhoods rather than in clinics, and providing at-home testing kits, communities can be activated in care at an exceptional level. Despite the COVID-19 pandemic raging, the needs of the HIV pandemic didn’t stop. And while meeting those needs faltered some (with 4.5% fewer mothers receiving vertical transmission prevention medications, an 11% drop in prevention programming, and a 22% reduction in testing services), in some areas meeting those needs thrived. Global Fund’s report found South Africa was able to increase the number of people receiving antiretroviral therapies by more than three times the baseline, even while fighting on two fronts.
Dr. Sioban Crowley, Head of HIV at the Global Fund, pointed out these program designs are not exclusive to HIV, “If we can keep 21.9 million people on treatment, we can probably deliver them a COVID test and a vaccine.”
Indeed, with the United States’ (and the world’s) response relying heavily on expertise gained in the fight against HIV, one can reasonably ask “If we know how to beat this, why aren’t we…just doing that?”
“That” being what advocates have long asked for: a more dedicated, equitable landscape and adequate support of our public health systems. As with COVID-19, a vaccine won’t “cure” us of HIV if the rest of the world cannot access it. As with HIV, if preventative services, adequate testing, and necessary education are not readily made available to people where they are, we will continue to fail in both fights. If we don’t wish to repeat the losses we’ve already experienced in the fight against HIV, then we cannot keep making the same mistakes of kicking the costs of these investments down the road and maybe, eventually “getting to it”.
As has been said many times through the latest pandemic, “the best time to do the right thing was yesterday. The next best time to do the right thing is today.” It’s time for us to do the right thing and stop allowing backbone public health programs to fall by the wayside in the face of the next emergency. Today, for the next few years, it’s COVID. We don’t need to “wait” for that to end. There’s two pandemics occurring, it’s time we act like it.
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.
Covid-19: How Far We’ve Come & How Far We Have to Go
Unraveling a tangle of yarn can be maddening. Pull here, threads get tighter. Pull there, you’ve created another knot. Now, imagine having to weave with the same tangle – “undo” a well-organized mess and make it something functional, beautiful even. The fragile public health system in United States during the Covid-19 pandemic is much like that tangled yarn.
This dual task is very much an oversimplified explanation of where the American health care landscape exists in this moment. Like most collective traumas, this stage isn’t the “undoing” stage, it’s the stop the damage stage. In writing the first blog of the year, tracking site Worldometers reported 20 million confirmed COVID-19 cases in the United states and about 345,000 COVID-19 deaths. As of the time of this writing, the same site is reporting more than 30 million confirmed COVID-19 cases in the US and about 550,000 COVID-19 deaths. Daily case counts continue to remain high at around 50 thousand confirmed cases a day and around 1,100 deaths per day on average. While the introduction of 3 vaccine products has brought hope and another tool to our COVID toolkit, and daily new cases and deaths are far below their height, the pandemic still rages on.
Which is…concerning for the entirety of the health care spectrum and especially so for those spaces that have been historically underserved or needing additional protection or funding. From the Centers for Disease Control report at the Conference on Retroviruses and Opportunistic Infections (CROI) the United States performed at least 700,000 fewer HIV screenings and 5,000 fewer new diagnoses in the first 6 months of the pandemic (compared to the same time in 2019) to the extraordinary implications of COVID among vulnerable populations to Senators Grassley and Klobuchar introducing legislation to allow drug importation (despite very clear warnings about why this is not a great idea) to the Biden Administration issuing a formal disapproval of Medicaid work requirements, to say information is coming at “break neck speed” may well be as much of an understatement as a tangled ball of yarn.
With an emerging “surveillance gap” for both HIV and HCV, a startling HIV outbreak in West Virginia, overdoses increasing as a result of COVID, some of greatest tools gained in combating this pandemic, even those advocated for by the CDC, have already started to go away as states begin to “open up”. Indeed, Congress has already begun taking up old questions regarding telehealth restrictions and payment systems designs, this time with an eye for permanency.
While President Joseph R. Biden’s American Rescue Plan, recently passed by Congress and signed into law, offers a great deal of funding to address the needs of certain entities and programs to tackle COVID and even offers the most meaningful adjustments to the Affordable Care Act by expanding subsidies, the existing needs of the health care ecosystem have largely been neglected for the last year. Well…far longer…but I digress. Like any trauma, our need to strengthen patient protections and access, incentivize quality of care over quantity of services, and meaningfully reduce health disparities have been the ends of thread tightening around the knot of COVID. This pandemic did not create these disparities and the needs outlined above – but not having a plan for a pandemic, not addressing structural inequities and these burning policy needs with the urgency they so deserve absolutely made us more vulnerable to the most devastating impacts of any pandemic.
This isn’t “the end”, certainly. For advocates, this has always been our “normal”. We need those who have hung on our every word and insight through this emergency to stay at the table – we’re not done yet. Everything you were outraged by (and may still be enraged by thanks to vaccine access scarcity) remains and will continue to loom just over our shoulders, waiting to be exploited by an opportunistic disaster.
Indeed, the ghost of Scott County may well continue to haunt us for some time to come. This is, after all, a very big ball of very tangled yarn.
Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona
[Editor’s Note: This blog is, in part, a replication of a blog hosted by the ADAP Advocacy Association. Supplementary policy analysis on hepatitis treatments continues in this blog]
It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted here, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.
However, like all health care policy, the details matter.
In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers.
In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.
For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.
In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”
To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.
“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”
The state’s ADAP and Medicaid formularies also present a similar situation for medications used to treat Hepatitis C, leaving a critical gap in available health care services and treatment for those at risk of contracting Hepatitis C. While the state’s ADAP coverage includes most direct acting agents, Arizona’s Medicaid formulary only covers Epclusa, Mavyret, Ribovirin, and Peginterferon.
Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs, tackle the absolutely critical inclusion of treatment and retention in prevention efforts, and to eliminate viral hepatitis, the details matter and advocates will need to adapt old fights to new environments.