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.

Special Interests Favor S.4395, but Patients Oppose It...Here's Why

This blog post is a collaborative piece, co-written by Brandon M. Macsata, CEO of ADAP Advocacy Association, and Jen Laws, CEO of Community Access National Network.

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment.

• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.

• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.

• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions.

• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!