States Push PDABs Despite Warning Signs, Patient Concerns

The debate over how the U.S. tackles rising healthcare costs is as constant as the sun setting in east. Most Americans feel the financial pressures from the high cost of their healthcare, evidenced by individual households holding 27% of the nation’s $4.3 trillion health-related expenditure burden. Healthcare spending is fragmented and multifaceted, being comprised of expenses such as hospitals, residential and personal care facilities, medical providers, technology, and retail prescription drugs. Despite the complexities of the healthcare market, pharmaceutical expenditures are often the most simple target to attack, often accompanied by solutions that seem way too good to be true. The fact is, access to prescription drugs is a significant part of modern medicine but there is nothing simple about how prescription drugs are brought to market and sold to consumers. In 2022, $633.5 billion was spent in the U.S. on prescription drugs, yet overall prescription drug expenditures by the government, private insurers, and patients were less than $1 out of every $7 spent on healthcare.

In recent history, in an attempt to create a “simple” solution to the costs John and Jane Q. Public pay for prescription drugs, through legislation, several states have created PDABs. PDABs are Prescription Drug Affordability Boards, also called Prescription Drug Advisory Boards. In theory, a board created to lower the cost of drugs for patients sounds like a good thing. However, the manner in which PDABs are currently set to operate is more harmful than good. Patients are not included in the development of the PDABs' decisions when those decisions directly affect their lives.

That is why the Community Access National Network (CANN) entered this policy and advocacy space. The boards have the wrong focus and don’t have patients’ interests as the priority. There is a difference between access and affordability. Jen Laws, C.E.O. of CANN, states, “Ultimately, CANN's focus is 'access' - it's in our name. Cheap gimmicks often pose serious potential to disrupt access for patients because we're the interest group here with the least in the way of resources (time, money, manpower). It's why we do what we do, and it's why we're going to keep doing what we do."

The prevalent tool PDABs utilize to lower costs is Upper Price Limits, or UPLs. The myopic focus is the allowable maximum a plan might reimburse a pharmacy or provider for any particular medication. However, this focus is not on lowering the price of what patients pay. A UPL does not determine what drug manufacturers charge for their drugs. It only sets the maximum that insurance plans will reimburse for drugs. That does not directly benefit patients because there is no mandate to pass any “savings” back to patients, for plans to retain medications with lower reimbursements, or for patients to have lower cost-sharing related to these medications. In general, patients pay for medications through co-pays and patient assistance programs. Although UPLs lower drug prices for payors, they increase the price patients potentially pay in terms of access by threatening the financial stability of providers and pharmacies, incentivizing utilization management that prioritize certain medications over others (regardless of an individual patient’s needs), and disrupt the provider-patient relationship by inserting the interests of payors over that of patients.

CANN has created multifaceted resources to educate the public about PDABs, their challenges, and possible solutions. People engage and comprehend in different ways. As such, CANN created varied communications. Long-form blog posts were written to be detailed sources of education and advocacy. A white paper was created as a downloadable handout to empower patients and enable them to engage with local PDABs or legislatures that are considering them in states that do not have them yet. For visual learners, CANN created an animated video that gives an overview of PDABs and their challenges, which is digestible and easily shareable.

With UPLs, the price patients potentially pay by losing access is more damaging than the monetary price tag of a drug a payor considers. UPLs that are set too low can cause drug manufacturers to reduce the production of drugs or place drug purchasing groups in the position of discounting distribution to a particular state altogether if low reimbursement makes them too costly to sell in that state. No purchaser or re-seller can sell to a state at a cost. No pharmacy can distribute a medication that costs them more to provide than they get paid in return. This creates shortages or removal of life-saving medications from the market, resulting in delays in care or patients being forced to utilize medicines that aren’t as efficacious as they and their physicians’ desired prescriptions.

UPLs also damage patient access by adversely affecting the 340B Drug Pricing Program entities that use the revenues from discounts to provide medications and other healthcare services to vulnerable populations without recourse for care. Lower revenues mean fewer services and possibly closures of facilities or program restrictions. AIDS Drugs Assistance Programs are largely dependent on using their 340B savings to extend access to care to poorest people living with HIV. We’re already seeing providers discuss this concern relative to insulin price caps. In a recent 340B Report article, the issue is summed up as follows: “Before 2024, most insulins had list prices of $300-$500 or more and were 340B penny-priced, so 340B providers earned savings of $300-$500 per prescription, Meiman said. However, now that many insulin list prices are $35, the 340B savings could drop to around $8 per prescription, she said. Historically, 340B savings on insulin have accounted for around 10% of community health system 340B revenue, she said.” Colle Meiman, a national policy advisor for the State & Regional Associations of Community Health Centers, also acknowledged this problem is a bit “counterintuitive” to how most policymakers think about drug pricing and reimbursements.

Moreover, lowering the price insurers are allowed to pay for medications is a double-edged sword. While on the surface, it seems like it would save payors money, it potentially only benefits PBMs in the short term and is an additional barrier to patient access. PBMs make their money from the profits they get via drug rebate revenues. Low UPLs will result in drug manufacturers lowering rebate levels and therefore lowering how much PBM’s might make on a particular medication. This means that PBMs could potentially increase the occurrence of benefit designs that restrict drug formularies to steer towards medications that result in more profit, not what is best for patients’ health. This already happens and is a concern many providers are beginning to voice. Additionally, they could enforce more utilization management, which again is a barrier to access but a way to increase their profitability.

CANN is energized to shine the light on PDABs and offer better solutions. Jen Laws explains, "Instead of nonsensical quick fixes, which aren't fixes to anything other than next quarter profits for payors, legislators should be focused on addressing the self-dealing nature of 'vertical integration', shoring up incentives for innovation, and meaningfully fixing benefit design that currently disadvantages patient access." Instead of a PDAB, states should consider a board focused on the patient perspective to evaluate benefit plan designs and offer recommendations to each state legislature about policy actions that will benefit patients as the priority stakeholder group.

In partnership with HealthHIV and The AIDS Institute, CANN will continue this work. It's crucial to stay abreast of the inner workings of policy and to advocate for the public proactively. Digging into the weeds with a patient focus enables advocacy groups to sound the alarm to the public as well as take the patient's perspective to those in power. Those in power are detached from the humanity behind the dollars and cents on their financial ledgers.

Eye on 2024: Federal Action on PBMs, 340B, and Telehealth

2024 stands as a pivotal year in federal healthcare policy, potentially overshadowed by a highly contentious and partisan political landscape during an election year. The backdrop includes ongoing budget fights, looming cuts threatening vital healthcare programs, and a shifting balance of power in Congress thanks to at least one member being removed from office and a couple of high-profile resignations, further complicating the path to meaningful bipartisan legislation. Amidst this chaos, key focus areas such as reforms related to Pharmacy Benefit Managers (PBMs) and the 340B Drug Pricing Program, as well as telehealth expansion are at the forefront of potentially significant policy shifts, all while renewed attacks on the Affordable Care Act (ACA) add to the uncertainty of healthcare reform in an election year.

Pharmacy Benefit Managers: Pushing for Transparency and Market Reform

PBMs have come under increasing scrutiny in the U.S. healthcare system, particularly regarding their role in prescription drug pricing. Dominated by just three key players, PBMs face criticism for opaque pricing models and practices that may contribute to rising drug costs. The Lower Costs More Transparency Act of 2023 represents a bipartisan effort to enhance transparency in PBM operations, requiring detailed disclosure of pricing and costs. The future of this legislation depends on whether the Senate will adopt the House version or introduce its own bill, with several Senate committees recently advancing similar proposals.

Experts, including those from the Brookings Institution, caution that while increased transparency is a positive step, it may only modestly impact overall drug costs. The effectiveness of these reforms hinges on addressing the complex relationships among PBMs, drug manufacturers, insurers, and healthcare providers.

The current PBM model, often criticized for incentivizing high drug list prices through 'spread pricing,' is under review. Proposed reforms, like those in the Pharmacy Benefit Manager Reform Act, aim to eliminate spread pricing and ensure that rebates and savings directly benefit plan sponsors and patients.

Additionally, the PBM market's consolidation and “vertical integration” (or self-dealing by another name) raises concerns about market power and its influence on drug pricing. With a few firms controlling a significant market share, PBMs' market power could lead to disproportionate profits, underscoring the need for regulatory measures to ensure fair pricing and competition.

As the healthcare community navigates these reforms, the focus remains on ensuring that changes in PBM operations directly benefit patients, especially those in underserved communities disproportionately affected by high drug costs.

340B Program: Addressing Challenges for Future Reforms

The 340B Drug Pricing Program, essential for providing discounted drugs to healthcare providers serving underserved communities, is at a critical juncture. Facing legal challenges and calls for reform, 340B is under scrutiny, particularly regarding its operational complexities and the definition of a 340B-eligible patient. This definition, crucial in determining who accesses discounted drugs, has been a point of contention, with legal interpretations suggesting a need for broader inclusivity, as noted in Bloomberg Law's analysis.

Advocates, including those supporting people living with HIV, recognize the program's significant impact but seek more direct patient benefits, a sentiment echoed in CANN's blog. The current model's effectiveness in providing direct patient benefits, such as reduced drug prices, is being questioned.

Efforts for greater transparency and accountability are intensifying, with state-level initiatives aiming to ensure that program savings directly benefit patients, especially those with financial barriers to medication access, as highlighted in Avalere's insights. State authority to regulate 340B, however, is still in question as Arkansas and Louisiana face lawsuits around recently passed legislation.

Amidst these challenges, 340B's commitment to aiding underserved communities remains paramount. Collaborative efforts among lawmakers, healthcare providers, and patient advocacy groups are crucial to reform the program, ensuring it continues to provide equitable access to care and addresses key issues like medical debt.

Telehealth: A Defining Year in 2024

2024 is set to be a defining year for telehealth, a sector transformed by the COVID-19 pandemic. This year will witness crucial legislative decisions that could shape the future of access to telehealth services.

At the forefront are policy decisions regarding Medicare reimbursement flexibilities for telehealth, as noted in Modern Healthcare's article. Set to expire in 2024, these flexibilities are vital for the continued viability of telehealth, particularly benefiting small practices and those in rural or underserved areas.

Another key development is the anticipated update to remote prescribing rules for controlled substances. The decisions made will crucially balance the need for accessible care with the regulation of controlled substances, impacting how telehealth can be used for medication prescribing.

As 2024 unfolds, the healthcare community faces the challenge of navigating these legislative and policy changes to maximize the benefits of telehealth in patient care and access.

Budget Battles: Critical Healthcare Advocacy Amid Congressional Challenges

The intense budget battles in Congress, underscored by proposed cuts in the House L-HHS Appropriations Bill (H.R. 5894), are central to healthcare advocacy. These cuts, amounting to $767 million, pose a significant threat to essential HIV/AIDS programs, risking the reversal of years of progress in treatment and care. These programs are not just healthcare initiatives; they are vital lifelines providing necessary medications and support to individuals living with HIV.

The Coalition on Human Needs has expressed grave concerns about potential severe cuts to non-defense discretionary appropriations (NDD) for fiscal year 2024, which could drastically impact a range of vital services. In their sign-on letter to Congressional leaders, they warn that these cuts, potentially up to 9% according to the Center on Budget and Policy Priorities, would significantly harm programs essential for public health, education, environmental protection, and more, affecting diverse communities across America. The Coalition advocates for completing the FY24 appropriations process with a bipartisan approach, emphasizing the need to protect these crucial investments that support the nation's most vulnerable populations and uphold the commitment to public health and welfare.

Any major legislative changes will be at the mercy of presidential election year politics, and the congressional balance of power will only make it harder. Issues like PBM reform, or 340B reform, and Telehealth expansion will probably receive a lot of attention via hearings and news clippings, but legislative action remains in doubt.

Upholding Our Ethical, Moral, and Bipartisan Commitment to HIV/AIDS

"Where your treasure is, there your heart will be also."

These words from Jesus found in Matthew 6:21 resonate profoundly as we examine the current legislative actions on HIV/AIDS funding in the U.S. Congress. It is hard to imagine forty years into the epidemic that we’d be witnessing a systemic attack on numerous HIV-related programs, especially ones with proven track records of success. The House L-HHS Appropriations Bill (H.R. 5894), proposing a staggering $767 million in cuts to domestic HIV programs, starkly contradicts the values of compassion and faith professed by certain lawmakers. These cuts, detailed by the AIDS Budget and Appropriations Coalition (ABAC), threaten to dismantle decades of public health progress, disproportionately impacting marginalized communities, minorities, and the LGBTQIA+ community. The appropriations bill is only the tip of the iceberg.

The irony of these legislative actions is both profound and deeply troubling. Lawmakers, often vocal about their 'pro-life' stance, are endorsing policies that will cause significant harm to millions of Americans dependent on HIV services. This bill represents more than just fiscal adjustments; it's a direct attack on the services and supports afforded to people living with HIV (PLWH), reflecting a worldview that stigmatizes and punishes rather than supports and heals. This approach starkly betrays the bipartisan legacy of the HIV/AIDS fight, which brought together the ideological opposites of the late Senators Orrin Hatch (R-UT) and Edward Kennedy (D-MA).

The bill's proposed eliminations include funding for the bipartisan Trump-era Ending the HIV Epidemic Initiative, the Ryan White HIV/AIDS Program, and the Community Health Centers Program. Alarmingly, it suggests completely eliminating Part F of the Ryan White HIV/AIDS Program (RWHAP), which supports critical components like Dental Programs and AIDS Education and Training Centers. Additionally, the bill proposes a 53% cut in the Minority HIV/AIDS Fund and the total elimination of Minority AIDS Initiative funding within the Substance Abuse and Mental Health Services Administration.

But the attack isn’t exclusive to domestic programs combating HIV/AIDS.

The stalemate over the reauthorization of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), as highlighted in a recent POLITICO article, further exemplifies the moral failure of the Freedom Caucus – which is driving most of the vitroil behind these proposed cuts. Disputes over abortion and a blatantly bigoted reluctance to aid Africa have jeopardized the most successful global health initiatives of our time.

“I’m disappointed,” Rep. Michael McCaul (R-Texas) told POLITICO. “Honestly, I was looking forward to marking up a five-year reauthorization, and now I’m in this abortion debate.” Additionally, he said, “a lot of the Freedom Caucus guys would not want to give aid to Africa.”

Jen Laws (he/him/his), President & CEO of the Community Access National Network (CANN), poignantly captures this duplicity in a tweet: “HIV is a bipartisan issue and always has been. May those who wish to insert their culture war politics onto this historical space enjoy their moral rot for as long as the spotlight lasts because the sense of power certainly won't.”

We stand at a critical crossroads, not merely facing a policy challenge but a profound moral crisis. The battle against HIV/AIDS reflects our societal values of empathy, compassion, and collective responsibility. The proposed cuts and the deadlock over PEPFAR reauthorization challenge the very foundations of equity and justice, calling for a decisive response to maintain the fragile progress made in HIV/AIDS care and prevention. These cuts are not distant policy changes; they are immediate threats to lives and well-being, demanding our urgent attention and action.

Critical Juncture

RWHAP and PEPFAR stand at a critical juncture, pivotal to the global and domestic response to HIV/AIDS. The Ryan White Program, a testament to America's commitment to combating HIV/AIDS, is under threat from the proposed House L-HHS Appropriations Bill (H.R. 5894), which includes significant funding cuts. Concurrently, PEPFAR, a global beacon in the fight against HIV/AIDS and the largest commitment by any nation to address a single disease, faces legislative hurdles that could impede its future effectiveness.

The Ryan White Program has been a cornerstone in achieving a 90% viral suppression rate among its clients, as reported by the Health Resources and Services Administration (HRSA). PEPFAR, on the other hand, has been instrumental in saving 25 million lives and supporting over 5 million infants born HIV-free, providing antiretroviral treatment to over 20 million people across 55 countries. This program has played a crucial role in significantly reducing new HIV infections worldwide.

The potential funding cuts under H.R. 5894 pose a severe risk to the Ryan White Program's continued success in the United States, especially in light of the 12% decline in new HIV infections from 2017 to 2021. The reauthorization stalemate of PEPFAR underscores the moral failure of certain lawmakers, who, despite their 'pro-life' claims, are obstructing a program that has been a lifeline for millions globally.

Comprehensive Strategy is Key

The achievements made over the last four decades in the fight against HIV/AIDS underline the necessity of a comprehensive strategy. The increase in PrEP prescriptions in the United States and the high rate of viral suppression achieved through treatment as prevention exemplify the effectiveness of a holistic approach, encompassing treatment, prevention, care, and support services. It is crucial that policymakers and the public recognize the importance of these programs and advocate for their continued support, ensuring the progress in combating HIV/AIDS is not only maintained but also advanced. Time is of the essence to embrace and implement a comprehensive HIV/AIDS strategy that goes beyond mere treatment to encompass prevention, care, and support.

Challenging Extremism and Fostering Advocacy

The battle against H.R. 5894 transcends mere policy disagreements. It represents a stand against a form of political extremism that poses a grave threat to marginalized populations, including people living with HIV/AIDS. These proposed cuts, in stark contrast to the proclaimed pro-life stance of the very lawmakers pushing them, unveil a troubling hypocrisy reminiscent of the words of Jesus in Matthew 23:27-28: "Woe to you, teachers of the law and Pharisees, you hypocrites! You are like whitewashed tombs, which look beautiful on the outside but on the inside are full of the bones of the dead and everything unclean."

Just as Jesus admonished the outwardly righteous but inwardly corrupt, these policies, under the guise of fiscal prudence, risk causing significant harm to the most vulnerable, particularly PLWH, minorities, and the LGBTQIA+ community. The stark contrast between the proclaimed values and the actual legislative actions of these lawmakers echoes the biblical warning against such duplicity. The time to stand against this political extremism is now. We cannot afford to be bystanders as these policies threaten to unravel decades of progress.

A Resounding Call to Action:

This critical juncture calls for a united, nonpartisan response from all who value public health, health equity, and human dignity. Health and human dignity are not political weapons to be wielded in service of talking points when lives hang in the balance. We urge individuals and organizations across the political spectrum to join the Southern AIDS Coalition in their efforts to push back against these cuts by signing their letter. Your voice and actions are crucial in shaping the future of HIV/AIDS policy and ensuring our continued progress towards Ending The Epidemic.

There are easy to use tools to contact your congressional representation in Congress. Not sure of your congressional district or who your member of the U.S. House of Representatives is? This service will assist you by matching your ZIP code to your congressional district, with links to your member's website and contact page. Or complete this online form to find your two U.S. Senators.

Now is the time to reaffirm our bipartisan commitment to fighting HIV/AIDS. This battle is not just about preserving past achievements; it is about resolutely advancing our collective efforts against HIV/AIDS. Your involvement is not just beneficial; it is essential. By standing together, regardless of political affiliation, we can overcome these challenges and continue our journey towards a world free from HIV/AIDS. Act now, for this fight is about life, justice, and human dignity. Your voice and action are indispensable in this crucial hour.

Underprepared: Opioid Settlement Dollars are Coming

Past public health crises have led to significant settlements. The 1998 Tobacco Master Settlement Agreement, for instance, was heralded as a landmark deal. Major tobacco companies agreed to pay billions to 46 U.S. states, funds that were ostensibly earmarked for anti-smoking campaigns and health programs. Yet, as research from RAND later revealed, a significant portion of these funds were diverted to unrelated projects. The promise of a healthier future was overshadowed by the allure of immediate fiscal relief, a misstep that has had lasting implications and begs the question. Will the opioid settlement reach the same result or have states learned their lesson?

Recent Concerns

Probably not, as the misuse of settlement funds remains a concern:

•COVID Funds Misdirection: In a move that sparked controversy, some states opted to use COVID relief funds for prisons, diverting resources from pandemic relief efforts. This decision underscores the tension between immediate fiscal needs and long-term public health goals.

•Mendocino County's Opioid Funds Dilemma: In a decision that drew sharp criticism, especially from those directly affected by the opioid crisis, Mendocino County used over $63,000 of opioid settlement funds to address a budget shortfall, despite having the highest rate of overdose deaths in California.

•New York's Opioid Funds Controversy: Raising eyebrows and questions about the state's priorities, funds intended for opioid crisis mitigation in New York were instead used for overtime expenses related to narcotics investigations.

The Current Landscape

While the anticipated $50 billion from opioid lawsuits offers hope, the lack of standardization and oversight in fund distribution is concerning. The primary objective of these funds is to bolster prevention, treatment, and recovery infrastructure, but it is feared that the absence of clear guidelines and reporting mechanisms will lead to misallocation and abuse. Only 12 states have committed to detailed reporting, emphasizing the need for transparency.

The Profit-Driven Rehab Industry's Ethical Crisis

Challenges posed by the profit-driven rehab industry in the U.S. include aggressive sales techniques, overcharging, and substandard care. The system often pushes vulnerable individuals into treatments that may not be in their best interest. The Affordable Care Act, while praised for mandating private insurance programs to cover addiction treatments, inadvertently led to a surge in for-profit rehab clinics, some of which prioritize profit over patient care, further emphasizing the need for rigorous oversight and quality standards. Few state officials are familiar with these market and health landscape dynamics, meaning few officials are ready to offer the necessary oversight of these dollars and the programs they’ll be going to support. That includes drug court programs.

A recent investigation by Spotlight PA highlighted the lax oversight of addiction treatment facilities in Pennsylvania. The Department of Drug and Alcohol Programs (DDAP) in Pennsylvania has been criticized for allowing providers to continue operating despite repeated violations and harm to clients. The tragic story of Adam Kalinowski, who died less than 24 hours after entering a treatment center known as Addiction Specialists, Inc. (ASI), serves as a poignant example. ASI had a history of violating state rules, and a wrongful death suit against them resulted in a judgment of over $1.6 million in damages.

Drug Courts

In response to surging drug-related criminal cases, drug courts have emerged as a solution, offering offenders a chance at rehabilitation instead of incarceration. However, there are serious vulnerabilities. Recent revelations in Louisiana provide an example of how lax federal oversight of the Department of Health and Human Services (HHS) grants funding of drug courts have lead to corruption, kickbacks, and questionable practices within these drug court systems and the treatment centers they refer defendants to.

In Lafayette, Louisiana, a mysterious $3 million appropriation for a substance abuse rehab facility became the epicenter of controversy. In the previous year, while the state Senate was formulating the state budget, an unusual amendment was introduced, directing $3 million to a governmental health organization in Lafayette for a 70-bed addiction treatment center. It was later revealed that three businessmen, Mark Fontenot, Jeff Richardson, and Leonard Franques, were advocating for this funding to establish a substance abuse rehabilitation facility in Lafayette. Franques is currently at the heart of an expanding bribery investigation that has implicated officials from the 15th Judicial District Attorney’s office in Lafayette, among others. The scheme involved DA Office kickbacks for steering pretrial diversion defendants to four businesses, including Lake Wellness Center, Franques' outpatient rehab facility.

The scandal in Lafayette highlights the intricate web of connections and potential conflicts of interest surrounding substance abuse rehab facilities, the justice system, and state legislatures who will be in charge of setting appropriations for these historic opioid settlement funds. Harm reduction and Justice advocates will need to work closely together in order to push for necessary “watch dog” activities and opportunities in these referral systems.

The Crisis of Medication Assisted Treatment Access for Minors

The rise of fentanyl has dramatically altered the landscape of opioid addiction. Teenagers are developing severe dependencies at an alarming rate, transitioning rapidly from experimentation to intense dependence. This swift onset of addiction underscores the urgent need for effective treatments tailored to this age group.

Despite the proven efficacy of buprenorphine, considered the gold standard for treating opioid use disorder, less than a quarter of residential treatment centers for adolescents offer it. This lack of access is deeply concerning, especially given the sharp rise in overdose deaths among teenagers, exacerbated by the proliferation of fentanyl.

Several barriers hinder the provision of MAT to minors:

•     Philosophical Objections: Some facilities object to medications like buprenorphine on philosophical grounds, despite its proven efficacy.

•     Lack of Expertise: Many treatment centers lack the necessary expertise to treat adolescents with MATs.

•     Stigma: The stigma associated with MATs, especially among teenagers, poses a significant barrier. If teenagers feel marginalized for taking medication, they might avoid it.

•     Systemic Barriers: A shortage of certified providers and underfunded facilities highlight the systemic challenges that need to be addressed to tackle the opioid crisis effectively.

The lack of MAT access for minors raises concerns about the allocation of opioid settlement funds. The funds are intended to address the opioid crisis head-on. If they aren't used to ensure access to MAT for all, including minors, public trust in the system could erode. Furthermore, without access to effective treatments and education, teenagers are at a higher risk of overdose and death. Addressing the barriers to MAT access for teenagers is crucial to ensure that the funds are used effectively and that this vulnerable population receives the care they desperately need.

The Role of the Department of Health and Human Services

The HHS plays a pivotal role in shaping the nation's response to the opioid epidemic. It oversees fund allocation, issues grants to incentivize particular programming, and sets care standards. Ensuring these standards are stringent and patient-centric is vital. State health departments face challenges, including staffing shortages, which can impact fund management.

State Health Department Challenges

State health departments, such as the North Carolina Department of Health and Human Services (NCDHHS), play a crucial role in addressing the opioid crisis at the local level. However, these departments face significant challenges, including staffing shortages and budget constraints. For instance, the NCDHHS has grappled with a 28% vacancy rate, which has doubled since the onset of COVID. Such staffing shortages can severely hamper the department's ability to manage and allocate funds effectively. These challenges have direct implications for local initiatives, such as the Queen City Harm Reduction's housing pilot program, which faced delays due to funding issues.

Lack of Guidance on Contract Quality with Local Drug Courts

While the HHS provides oversight and sets standards for care, there has been a notable lack of guidance on increasing contract quality between local drug courts, private and publicly funded managed care programs, and providers. Given the potential for conflicts of interest and corruption within the drug court system, as evidenced by the Lafayette bribery scandal, this lack of guidance is concerning. Ensuring transparency, accountability, and quality in contracts is a key factor that will ensure opioid settlement funds are effectively used at every level.

Conclusion and Call to Action

The opioid epidemic presents a monumental public health challenge. The opioid settlement funds offer a unique opportunity to address these interlinked crises. However, without stringent oversight and a clear roadmap, there's a risk that these funds might not be used to their maximum potential.

The rapid allocation of funds without proper oversight is a recipe for disaster. It's crucial to ensure that these funds are channeled into comprehensive programs that not only address OUD but also the associated risks of HIV and HCV infections.

The opioid epidemic and the associated settlement funds present both an opportunity and a challenge. Proper oversight is essential to ensure these funds are used effectively. Advocacy groups, community leaders, and stakeholders must rally together to push for rigorous HHS contract quality standards, ensuring transparency and accountability.

Feds: “Harm Reduction Framework”

On May 15th, Substance Abuse Mental Health Services Administration (SAMHSA) published a document which seeks to “…inform SAMHSA’s harm reduction activities moving forward, as well as related policies, programs, and practices,” and “to inform SAMHSA of opportunities to work with other federal, state, tribal, and local partners toward advancing harm reduction approaches, services, and programs.” The document, called the Harm Reduction Framework, specifically acts as a “level setting” document in addressing substance use as a public health issue.

While the document includes reach within the Office of National Drug Control Policy (ONDCP) and other agencies, like the Centers for Disease Control and Prevention (CDC), it does not have any “mission control” or enforceable policy influence with the Drug Enforcement Agency (DEA) or other law enforcement, which has been a central tool in federal, state, and local government responses to drug use and the opioid epidemic. Indeed, “law enforcement” only shows up once in the document’s contents and once more in the document’s references list. Arguably, whereas the document serves well as a “level setting” opportunity between various stakeholders, which claims to include “law enforcement” personnel, this effort is admirable but will lack “teeth” due to harm reduction as a programmatic idea from a public health lens when law enforcement remains a contraindicated method of response.

SAMHSA has also asked for specific feedback on the framework by way of a public comment form, indicating an effort more to formalize the framework's ideas as a policy stance.

The form follows the flow of the document with the first question seeking general and overall feedback. The second question asks for feedback on the document’s introduction and review of the working group, why the document exists, and historical recognition of how harm reduction has operated in response to substance use. This should be relatively uncontroversial for most respondents. The majority of feedback may seek to clarify or otherwise add details which lengthen the document, if adopted, but will not necessarily impact the substance of this section. The only area which might become “sticky” is the inclusion of “sex work” among “behaviors” associated with substance use and among those who might benefit from harm reduction programming.

The next four questions seek feedback on the core chaptered content pf the document as follows:

• “Pillars” of harm reduction

• “Supporting Principles”

• “Core Practices”

• “Community-Based Harm Reduction Programs” (CBHRP)

The document’s Pillars are outlined to include:

1. Guided by people who use drugs (PWUD) and with lived experience of drug use (this might also include family members, intimate partners, friends, and so forth of PWUD)

2. The inherent value of people

3. Commits to deep community building and engagement

4. Promotes equity, rights, and reparative social justice

5. Offers low-barrier access and non-coercive support

6. Focuses on any positive change as defined by the person

Supporting Principles include:

• Respecting autonomy

• Practicing acceptance and hospitality

• Providing support

• Connecting family (biological and chosen)

• Provides many pathways to wellbeing across the continuum of health and social care

• Values practice based evidence and on-the-ground experiences

• Cultivates relationships

• Assists and not directs

• Promotes safety

• Engages first

• Prioritizes listening

• Works toward systems change

Core Practice Areas” include:

• Safer practices

• Safer settings

• Safer access to healthcare

• Safer transitions to care

• Sustainable workforce and field

• Sustainable infrastructure

The final segment focuses on a brief description of CBHRPs, up to and including research projects used to explore innovation and efficacy of particular programs.

This section is noted with an asterisk “as permitted by law” – a nod toward the issue of law enforcement as a primary response tool to substance use and the limitations of SAMHSA as a result.

Advocates should anticipate some funding and program initiatives to reflect the general ideas around this framework or any final product around this framework. However, those barriers as a result of law enforcement and politicized attitudes will remain a barrier and perhaps present challenges for implementing novel programs. Strategically, much like SAMHSA’s drug court grants, the agency should consider how to leverage supportive funding incentives for states and municipalities to involve themselves in any resulting programming.

The public comment period is open until August 14th.

HIV Advocates Gather in Nashville for Health Fireside Chat

From April 27th through 29th, ADAP Advocacy Association (aaa+) hosted its first Health Fireside Chat of the year. The series was rebranded to encompass a broader focus on public health, changing from the HIV/AIDS Fireside Chat to the Health Fireside Chat. Unlike previous Fireside Chats, Nashville’s event added an “ice breaker” activity, themed in light of the hosting city – a line dancing lesson, as well as a town hall meeting convened in partnership with Positively Aware. The additional half day of activities - including the ice breaker, townhall meeting, and meet and greet - allowed attendees to settle into conversation expediently after having a solid hour of good laughs, encouragement, and bonding. Once down to business, policy discussions focused on Tennessee’s politically-motivated decision to decline HIV prevention funding, reforming the 340B Drug Discount Program to better meet patient needs, and the intersection between U=U (undetectable equals untransmittable) and reforming HIV criminalization laws.

The townhall meeting, which was facilitated by Rick Guasco, Acting Editor-in-Chief of Positively Aware, started with recognition that Nashville was explicitly chosen as a hosting city due to the state of Tennessee’s rejection of federal HIV prevention dollars. While a later discussion was specific to that issue, the town hall dug into underlying (and broader) concerns around systemic discrimination as a driver of today’s HIV epidemic. Digging into how racism, as an example, manifests can be a touchy subject in any group, even among those who generally align. Such a charged set of topics, especially among HIV’s thought-leadership, can and does lead to transformational moments, particularly because creating a space of “internal” advocacy provides a chance for us to experience, and navigate, conflict amongst ourselves. That conflict and navigation also provides us a chance to grow together and to break down silos of interest, work, and thought. And this townhall did exactly that.

The first policy session, “Tension in Tennessee: Is an HIV Access to Care & Treatment Crisis Looming?”, lead by the O’Neill Institute’s Jeff Crowley, invited local advocates to discuss their internal view of Tennessee’s “troubles” with some national advocacy representation. While much of the discussion focused on the details of local communication and national assumptions, some discussion on how the state may implement its newly allocated funding (will the state’s budget continue to fund prevention efforts next year?), much of the conversation that followed was explicitly about how local advocates can communicate and collaborate with national advocacy efforts. What became clear from that conversation is much of the national and state level advocacy we tend to reflect fondly of when speaking on decades past is relatively fragile and not well-coordinated. Planning bodies have diminished to largely being provider groups and some don’t even meet – despite a statutory requirement to do exist. An attendee with capacity building expertise pointed out the need for investment in this space. Many planning bodies have been weakened by atrophy, others have faced a demographic shift (and as a result a change in the barriers and assistance needed in order to appropriately activate affected community). The discussion as a whole highlighted the extreme silos working against a cohesive and collaborative advocacy network necessary to support ending the HIV epidemic.

340B remains an important issue for HIV advocates. As such, “340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions?“ was the focus of the second policy session. Some of the advocates in attendance knew little about the program, so the discussion provided an excellent educational opportunity on how the discount drug program works. Laser focused on issues of health equity, Kassy Perry of Perry Communications Group lead the group to dig in – and quickly. Advocates less familiar with 340B were readily able to identify the need for reform when assessing reductions in charity care and increases in medical debt. The group readily recognized 340B as a powerful tool toward addressing health disparities, especially economic consequences for patients, and where those consequences can and do negatively impact entire areas of patients’ lives. Attendees from industry partners listened intently as advocates described their concerns and the need for the program to better reflect the intent in which it was established.

Day two concluded with attendees enjoying a meal with one another, and a round of singing “happy birthday” to Brandon M. Macsata, the ADAP Advocacy Association’s CEO, who turned 50. This was truly a moment (many of them really) in which attendees got to buy into my desire to ensure our colleague felt loved and celebrated, since we were all together. All told, it is very likely Brandon heard the song “happy birthday” some two dozen times or more throughout the event (and I sincerely encourage ya’ll to do so again, if you find yourself in a meeting with him during the month of May).

The final policy session, “U=U: Is 'Undetectable Equals Untransmittable' Changing the Landscape for HIV Criminalization Laws?“, focused on the intersection of issues between U=U and reforming HIV Criminalization Laws with the conversation hosted by Mandisa Moore-O’Neal, executive director of the Center for HIV Law and Policy, and Murray Penner, executive director of U=U Plus. Mandisa shared with the group the exceptional nature of HIV criminalization laws, but also how general criminal codes are out of date, furthering the HIV epidemic, and nearly exclusively used against Black and Brown people living with HIV. Mandisa also discussed how these laws can and are leveraged to further domestic violence (and coercive control). Murray then discussed how laws which allow for “affirmative defenses” only help those people living with HIV which can readily access and maintain care. All of which emphasized that the design of these laws assume that because someone is living with HIV, they are necessarily presumed “guilty”. Advocates discussed how to break silos, including the potential to partner in prosecutor and public defender education efforts. Advocates focused on health or with strong relationships with their local health departments, for example, might wish to participate in education efforts alongside legal advocacy organizations or a state Bar.

The Health Fireside Chat series remain an exceptional retreat to advance thought-leadership, deep-dive policy conversations, as well as often-under appreciated advocacy collaboration. The ADAP Advocacy Association plans to host additional Health Fireside Chats later this year in Philadelphia, PA, and New Orleans, LA.

DEA Proposed Rules Risk Harming Access to Care

Since the beginning of the COVID-19 pandemic, the United States Drug Enforcement Administration (DEA) has held certain relaxed or waived rules regarding prescribing of controlled substances. On January 30th, President Biden announced his administration would end the public health emergency (PHE) declaration related to COVID-19 in May of 2023, after one, last renewal in February. Part of what’s being called an “unwinding” of the PHE includes returning to “normal” operations for executive entities like the DEA. But times have changed dramatically in terms of healthcare access since the beginning of the COVID-19 pandemic, most notably around the issue of telehealth. Thus, on February 24th, the DEA announced two proposed rules regarding permanent telehealth access and prescribing related to controlled substances.

The DEA’s controlled substances list is…controversial, to say the least. The five category list includes those which the agency has deemed to have the “potential for abuse or dependency” characterization. Schedule “V” (five) having a “low” potential for abuse relative to other levels and having sufficient medical value, resulting in quantity limits but, typically, not more than that in terms of regulatory impact. These medications include certain cough medicines and an anti-diarrheal medication, among others. Schedule “I” (one) substances as having been deemed to have “no” medicinal value, a high potential for abuse, and a lack of accepted safety for use even under medical supervision. These substances include marijuana, “ecstasy”, LSD, and peyote. In between these, you’ll find certain pain killers, treatment for attention deficit disorder (ADD), anabolic steroids, and medications used to treat opioid use disorder (OUD). The DEA’s proposed telehealth rules (here and here) would allow for a provider who has never conducted an in-person assessment of a patient to only prescribe up to a 30-day supply of schedule III-V non-narcotic medications and a 30-day supply of buprenorphine. In order to get a refill or maintain treatment, a patient would have to then arrange for an in-person assessment. For patients referred by a provider who has already conducted an in-person assessment in the last year or for providers who are directly prescribing the medication and have already had an in-person assessment in the last year, the limitations on telehealth would not apply.

Particularly, in the rules, the DEA argues medications used to treat OUD are at risk of diversion and misuse, despite evidence that misuse is relatively rare and declining and despite the fact that only about 11% of the population which could benefit from medication assisted treatment (MAT) have access, according to a report from the Substance Abuse and Mental Health Services Administration (SAMHSA). Reasons for limited access are slowly being addressed. Most notably, the “X-Waiver”, a program which limited which prescribers could offer buprenorphine and other MAT and how many patients they could treat. The “X-Waiver” requirements were repealed in Section 1262 of the Consolidated Appropriations Act of 2023 (otherwise known as the Omnibus). Another giant barrier to prescribing MAT is provider stigma. This stigma against people who use drugs (PWUD) often leads to patients having an exceptionally hard time finding a provider willing to help them, when they need it. Years of prescribing limits and the vagueness of the DEA requiring pharmacies to report “suspicious” orders (the DEA does not define what’s constitutes “suspicious”), has also left pharmacies, wholesalers, and distributors exceedingly cautious as not gaining the DEA’s ire. With these proposed rules, the biggest barrier to President Biden’s plan to expand access may be the bureaucracy he enabled as a Senator and Vice President (Politico details more here).

Additionally, some states are attempting to ban access to gender-affirming care; not just for minors but for anyone accessing public payer programs and even attempting to forbid private, commercial plans from offering gender affirming care. While these would not necessarily impact access to care for transgender women seeking out-of-state telehealth, it would adversely affect transgender men because testosterone is a schedule III controlled substance. Thus, under these rules, transgender men would have to have in-person assessment with a provider in order to begin or continue accessing prescribed testosterone replacement therapy. Where this is a bit of a “come uppins” moment for President Biden is in his historical record of championing the Anabolic Steroid Control Act of 2004, making testosterone and anything related to it a controlled substance. The law rose to a certain popularity because of major sports leagues in the United States insufficiently addressing steroid use among professional athletes. The world has changed greatly since then and most, if not all, of those entities have adopted tight controls and regular screenings of athletes (which do need some update to appropriately reflect the endocrinological variety the human species offers). A carve out in the law would allow for the DEA to exempt medications which “does not present any significant potential for abuse.”

Chronic pain patients, disability advocates, harm reduction advocates, and advocates for access to gender-affirming care are sufficiently outraged to see their life-saving care being ripped from the ease of telemedicine. Leo Beletsky, a law professor at Northwestern University said, “The fallout is going to be measured in lives lost.” Dr. Brian Hurley, the president-elect of the American Society of Addiction Medicine said, “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion.” “forcing people with disabilities who are immunocompromised or high-risk to choose between potential COVID exposure and forgoing vital medications is ableist and dangerous,” said Madeline T. Morcelle of the National Health Law Program. Adult ADHD patients are already fighting a shortage on their medications and providers who will prescribe them. And with the rural health care crisis limiting access to providers for queer people, disabled people, and PWUD, this rule will strip them of the only time they’ve seen their access to care expand in decades.

A bi-partisan, bi-cameral group of legislators have written a letter to the DEA cautioning against these rules and Senators Warren (D-MA) and Ed Markey (D-MA) have also written a letter to the U.S. Department of Justice, U.S. Department of Health and Human Services, and the DEA about de-scheduling testosterone. Neither letter has been answered yet. Orion Rummler of 19th News recently asked for an update and will be following up on the status of a response from the Biden Administration and executive agencies.

With these massive concerns on finding and accessing care, patients may well turn to the black market or grey market to self-manage the life-saving medications they need. This not only defeats the purpose of the DEA’s rules in attempting to prevent diverse by artificially creating a market for illicit trade, it exposes patients to risks of infections, counterfeit medications, and other safety hazards.

Patients should not have to risk their lives and even incarceration in order to access life-saving medications they have readily enjoyed over the last three years. The DEA should engage providers, advocates, and patients more than any other stakeholder from law enforcement to approach promulgation of these rules in a way that aligns with public health instead of carelessly chasing after ways to limit access to life-saving medications.

The proposed rules aim to come into effect in November. The public comment period ends on March 31, 2023. We encourage our partners, including those not directly involved in issues of substance use or production of controlled substances, to comment in support of adjustments to the proposed rules that would maintain telehealth access to care, meet the stated public health goals of the Biden Administration, and, most directly, maintain access to the life-saving medications patients depend upon. The public may submit comments here and here.

2023: Regulatory Items to Watch

Last week, the politically interested got to watch a preview of how the United States federal government will approach legislating for the next two years – it’s not pretty. With the narrowly divided U.S. House of Representatives barely eking out enough votes to select a Speaker, nearly coming to the time old tradition of fist fights in the process, passing meaningful legislation will be fraught, regardless of the issue at hand. None of that takes into account that Democrats still control the U.S. Senate (even if also by a narrow margin) and the priorities of both chambers are now split by party. There may be some surprising room for agreement though. As of the time of this writing, this may well be the first Republican-controlled Congress that is not riding on a platform of repealing or replacing the Affordable Care Act (ACA). That doesn’t mean potentially meaningful changes couldn’t come, it’s just highly unlikely.

That leaves the courts, which we discussed in our last blog, and the Biden Administration’s own executive authority through regulatory agencies to carry the burden of change through the 2024 election cycle. A few things to remember include the previous administration’s actions to pack the federal judiciary, including Supreme Court seats, the dynamic controls of implementation priorities between states and the federal government, and the Biden Administration’s support for insurers over the last two years will shape what we might see in terms of regulatory action.

A prime example of all of these factors playing out can be seen in Judge Reed O’Connor’s September 2022 ruling on Braidwood, wherein O’Connor ruled the ACA “preventative services mandate” was unconstitutional particularly because of the plaintiff’s objections to covering pre-exposure prophylaxis (PrEP) as violation of their religious beliefs and because of some wonky interpretation of delegation of powers or what defines an agent of the government and the process by which those agents are appointed. Notably, O’Connor has been previously overruled on highest profile rulings, mostly those with extreme anti-gay and anti-ACA positions…repeatedly. As this case makes its way through higher courts, the 5th Circuit is next, states may have the chance to implement their own versions of minimum benefits and services insurers and covered entities must provide. Much like the issue of Medicaid Expansion, this type of action would further disparities across states in terms of access to care, but would provide some protection for minimum coverages for residents of those states. Here we have the Biden Administration’s interpretation of both the law and the entity responsible for implementing the law, a federal court’s disagreement on process, and the state dynamic of “what do we do now?”

Let’s take a look at the annual Notice of Benefit and Payment Parameters (NBPP), issued to describe how insurers and providers must handle certain nuanced rules and regulations for a given benefit year. NBPPs are generally issued in the year prior to when the rule should go into effect, sometimes a little earlier but in enough time for insurers to make sure their plan offerings comply with the rule. The 2023 NBPP included provisions on the ACA’s non-discrimination rule and an effort to strengthen coverage and services to LGBTQ patients. This operated as a nod toward the Biden Administration’s aim at addressing rule-making for the ACA’s actual non-discrimination rule, known as Section 1557 (which has been subject to numerous lawsuits, including those in front of O’Connor). The 2024 NBPP, proposed rule (not final), looks to address some definitions of “network adequacy”, or making sure the benefit networks offered by insurers are meaningfully useful for patients and, with some theorized framework, hopes to make selection of a qualified health plan off the federal marketplace a little bit easier by introducing standardization. Watching NBPP final rules and processes will remain a prime opportunity to advocate with regulators, both state and federal, and read tea leaves of other regulatory actions down the road (in the 2023 NBPP final rule, which includes answers to some comments made about the proposed rule, the Biden Administration directly answered that it would be addressing Section 1557 in response to questions as to why the non-discrimination provisions did not go further to more explicitly protect transgender patients).

The Biden Administration will also get the chance to start to implement and define the rules around its prize jewel, Inflation Reduction Act (IRA), which, among other things, introduces the idea of drug price negotiation in public payer programs like Medicare.

Before we jump on some details to watch there, it’s important to note, the provisions of the IRA affecting drug pricings do not necessarily have a direct impact on what patients pay at the pharmacy counter and have zero impact on those patients not enrolled in affected public payer programs. Furthermore, when politicians of all stripes tout “saving money” in public payer programs, they’re not necessarily talking about patients saving money. Indeed, most of the time they’re not. They’re talking about reducing the costs to the federal government for operating those programs – sorta. The way it works is the federal government can’t really handle all of the medical and medication claims associated with these public payer programs, so they contract with private insurers or encourage patients to enroll in supplemented private plans to handle these claims and reduce the labor and expertise burden on the federal government. States do this too with Medicaid. However, those companies, particularly pharmacy benefit managers (PBMs) handle the costs of medications and formularies, engage in all the same dirty tricks with their public payer programs as they do with their private plan offerings, including abusive prior authorizations, step therapy, network limits, and steering patients to mail-order pharmacies which those entities then own. There’s little oversight given and limited regulatory action to prevent these private entities handle the administrative processes of these programs from abusing their role for the sake of their own profits.

Indeed, pharmacy benefit managers came about in our ecosystem promising to negotiate prices on medications already. And they have, in large part, successfully done so, either consuming dollars through rebate programs or negotiating lower prices by buying in bulk. However, PBMs haven’t shared those savings with patients, despite that being the selling promise. In fact, PBMs have been one of the fastest profit-growth businesses in the country because they’re not passing on those savings to patients.

That’s right, drug prices are already negotiated. So why haven’t we, as patients, really seen the benefit of that? Why are patients having to argue with their insurers constantly to get the medication coverage they need or watching their medication formularies shrink? Cuz PBMs are in desperate need of regulatory control. Hopefully, the Federal trade Commission’s most recent inquiry into their business practices will shed some light on these issues and well-motivated constituents can remind their Senators and Representatives we need more action. We’ll also need pressure on the Biden Administration on these issues. They’ve dodged it so far.

Back to the IRA, there’s some pretty cool stuff in the health care pieces. Particularly, the cap on insulin copays for Medicare patients is a big deal. The limit on out-of-pocket costs Medicare patients will pay on the medications is also a massively big deal. These are the provisions that will benefit affordability the most for most Medicare patients. But we’ll need to watch for our veggies on this plate, as it were. The trade-off might look like PBMs further limiting formularies and advocates need to keep an eye out for that. Cautious advocates have much to celebrate in these pieces, as they directly affect affordability of and access to care, and should remain watchful for how implementation and enforcement rolls out but also as to any unintended consequences which may need additional answers later.

Now, the drug pricing and negotiation pieces on the other hand, might dicey as time goes on. Nothing in the IRA requires any “savings” private administrators might receive or the federal government might view to be passed onto patients. Nothing. Furthermore, certain pieces of the IRA prevent judicial review, which means if patients find themselves adversely affected by a regulatory move or certain implementation of the IRA, they can’t sue to government to fix the issue. That’s never a good thing. It’s also a particularly bad thing to include in any legislation, especially as we look down the barrel of patients losing their right to private action to seek enforcement of non-discrimination and disability protection laws (again, see our previous blog). We should always retain the right to seek redress under our judiciary, even if only to give light to how “bad” legislation (or short-sighted provisions) might be hurting patients. One of the pieces affected by the non-review bit includes the “what-if a manufacturer refuses to play ball on negotiation of a particular medication?” The answer is the feds have the right then to remove ALL of that manufacturer’s medications from covered public payer programs. Now, that might seem like the manufacturer is the bad guy there. But the drugs targeted by the IRA are the highest cost medications on the market and the highest cost medications on the market are those typically designed to treat or manage rare, chronic, or life-threatening illnesses and in which there are limited or no alternatives. These areas also happen to be where manufacturers have been leading medications for quite some time, to the benefit of patients. More personalized medications mean more specific care for a patient’s needs. The “negotiation”, which is really not a negotiation when an ethical manufacturer seeking to recoup costs and generate enough revenue to reinvest in discovering and developing new medications, investing in underserved disease states, is essentially forced to take a hit or have their entire portfolio yanked out from patients. “Take the hit or we’ll hurt the people that it’s your mission to serve.”

Now, I have plenty of criticism for our industry friends. This shouldn’t be taken as “oh you’re a shill” moment. Rather, my biggest disagreement is the inability of patients who might lose access to medications to seek redress and the lie which premises the need for the federal government to “negotiate” prices. As described above, negotiation already happens and they dynamic of this law isn’t “negotiation” but hostage taking. And patient access to care is what’s being held hostage. None of that addresses what some suspect will be manufacturer responses by consolidation in the industry and increases in launch prices. Essentially, these provisions only put a bandaid on a gaping wound and it’s not even on the wound the public cares most about. It’s kinda hanging off to the side.

Ultimately, my view is the federal government should gladly invest in our care. “Cutting cost” has always and will continue to sound an awful lot like “that’s not something we really wanna spend money on or invest in”, regardless if it’s a private insurer or a politician. Our care, our health, our families matter and they should be an investment priority for political leaders.

We’ll spend plenty of time later this year discussing the other “alligators” “closer” to patients than manufacturers and why we need to address those actors first.

Future legislation that seeks to make care more affordable and accessible needs to work from the perspective of patients, not insurers.

The last thing we’re gonna touch is something that pretty much every patient advocate can celebrate, so long as it’s done right. In the later end of 2022, the Biden Administration proposed a rule to improve patient and provider experiences with the administrative burden insurers love to impose on us. Particularly aimed at addressing electronic health data exchanges and streamlining prior authorizations (PAs), a process which has been wildly abused by payers, the rule hopes to improve patient experiences in care. Often times, PAs result in denials of coverage in which a patient (or provider on a patient’s behalf) must appeal to the exact same payer that denied coverage in the first place. Those letters are often vague or confusing, or in my own situation for hormone replacement therapy, tell patients to try something they’ve already tried or was already included in the provider’s rationale for a specific medication or treatment course. The rule requires more specificity in reasons for denials, which would allow a provider to more directly address those reasons as inappropriate for the patient or, as is the case sometimes, not even based in medical science. The rule also seeks to speed up the process. Currently, many patients have to wait weeks if not months to get responses on PAs or appeals. The rule would require most PAs to be answered inside of 7 days or inside of 72 hours, if it’s urgent. The rule also forces payers to begin using more modern technology to review PAs. Rather than outdated forms, faxes, and even mail, payers would have to provide either a web portal or direct email address in which patients and providers might more securely ensure their request has been received. Lastly, the rule would require payers to post specified PA metrics. Be it care or medication, patients and providers would be able to view on a payer’s website just how often they deny care and how much burden that payer is going to place on them to receive the care they’re entitled to.

Now, the PA rule is, as many, limited in scope but not by much. It would apply to Medicaid managed care plans, ACA plans, the Children’s Health Insurance Program, and Medicare Advantage plans – nearly everybody.

Regulatory actions won’t be limited to these so keep an eye out!

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.