Upper-Payment Limits; Drug "Affordability" Boards Risk Medication Access
The opinion piece, authored by Jen Laws, CANN’s President & CEO, originally published in the September 2, 2023, print edition of the Denver Post. CANN will be hosting a free “PDAB 101” webinar for patients, advocates, and all public health stakeholders on November 1, 2023. Pre-registration is required. Register by clicking here.
To successfully combat the HIV epidemic and defeat other chronic conditions, patients must have uninterrupted access to the most effective medicines recommended by their doctors. As efforts to ensure patients can access their medicines are being defined in the public sphere, many state legislatures continue to advance policies and proposals focused on addressing patient affordability challenges.
However, many such actions fail to address high out-of-pocket costs and instead focus on lowering costs for other stakeholders within the health care system, like lowering costs and increasing profits for health insurers neglecting the patients they were intended to protect.
In Colorado and several other states across the country, lawmakers have empowered Prescription Drug Affordability Boards (PDABs) to address the rising costs that patients pay for prescription medicines. PDABs have the authority to select and review drug list prices and can recommend policies for drugs deemed "unaffordable." These list prices aren't something patients generally pay, rather we pay co-pays or are able to manage costs with patient assistance programs.
Despite this, one such policy being considered by the Colorado PDAB and similar boards in other states is an upper-payment limit (UPL). A UPL is a payment limit or ceiling that applies to all purchases and payments for certain high-cost drugs and does not necessarily translate into a "cost limit" for patients.
When UPLs are set, reimbursement rates are lowered for hospitals or clinics giving them less incentive to purchase specific drugs even though it may be the most effective medication to help a patient manage a chronic condition. When reimbursement rates are lowered through a UPL, it can also lead to barriers to biopharmaceutical companies investing in and supplying new innovative medicines to health facilities, making it difficult for doctors to prescribe treatments they think are best suited for their patients. While well intentioned, patients often bear the brunt of the challenges with such policies.
The impacts of the UPL process are only compounded when we consider the potential impact on the 340B Drug Pricing Program, a federal safety-net program that helps health facilities serve low-income and uninsured patients by offering them discounted drugs. Under the program, qualified clinics and other covered entities buy treatments at a discount to help treat vulnerable patients and get to keep the difference between the reimbursement rate and the discounted price leveraging those dollars to provide needy patients with medications and care they might not otherwise be able to afford.
Under a UPL, health facilities such as hospitals or clinics will receive lower reimbursements for prescribed treatments and therefore generate fewer dollars to support patients and the care we need to live and thrive. If the PDAB sets restrictive UPLs for drugs for chronic conditions like HIV, health facilities and the health professionals tasked with providing care will be faced with the decision to potentially stop prescribing these medicines and face having to cut support services that patients have come to rely on.
At a recent meeting of Colorado PDAB stakeholders, following the board's unanimous approval of the list of drugs eligible for an affordability review process, I voiced concerns about the approach to determining the value of lifesaving treatments for patients living with or at risk for HIV, hepatitis C (HCV), and other complex conditions. My concerns have only grown since, most recently, the state PDAB selected five drugs to undergo a formal affordability review including a treatment for HIV.
Many patients and other stakeholders have raised alarm to other drugs that are now subject to review to treat complex conditions such as psoriasis, arthritis, psoriatic arthritis, and cystic fibrosis. The implications of the Colorado drug "affordability" board's recent actions on patient access are grave and set a dangerous precedent. Ten states including Colorado have already established PDABs, and many others are following suit.
Those support services and continuity of care are critical to empower communities and improve the quality of life for people living with and managing conditions like HIV and hepatitis C. Despite the PDAB being "sold" to the public as a measure to improve patient experiences and access to care, the current model fails to prioritize patients at all.
Colorado is home to more than 13,000 people living with HIV and has been at the forefront of combating the disease. This year, state lawmakers advanced model legislation that protects patients' access to HIV prevention medication. However, the recent actions from the drug "affordability" board and short-sighted policies like the UPL process or mandatory generic switching could derail progress toward ending the HIV epidemic.
Price controls are, and will continue to be, a short-term, short-sighted "fix" with long-term consequences for patients living with chronic conditions. Policy efforts to address affordability must prioritize patient access and the ability for doctors to prescribe effective treatments. Colorado's PDAB, as it currently stands, falls short of that.
340B Hypocrisy: The Inconvenient Truth Behind Why We Need to Reform This Vital Safety Net Program
Brandon Macsata is the CEO of ADAP Advocacy. Jen Laws is the CEO of Community Access National Network.
The 340B Drug Pricing Program (“340B”) is probably one of the most transformative public health programs providing lifesaving supports and services to people living with HIV in the United States, second only to the Ryan White HIV/AIDS Program (“RWHAP”). As such, rigorous debate about the future of the program is not only healthy, but it is also paramount to its success. As patients (and patient advocates), it is our responsibility to demand accountability, transparency, and stability. There is universal agreement about the vital role 340B plays in improving access to healthcare. But for many – including ADAP Advocacy and the Community Access National Network – we contend that the program could be doing more…and better! The focus of the program should be on the patients, and not the Covered Entities, medical or service providers, or any other business enterprises making lots of money off it. That is the inconvenient truth behind why we need to reform this vital safety net program.
Section 340B of the Public Health Service Act (PHSA) is a Drug Pricing Program established by the Veterans Health Care Act of 1992. That year, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients; if pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, then they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple. Drug manufacturers could have a guaranteed income from participation in the Medicaid program and Covered Entities could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates and discounts affording certain healthcare providers a way to fund much needed care to patients who could not otherwise afford it.
“…to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R. Rep. No. 102-384(II), at 12 (1992)
THAT is the legislative intent behind 340B. THAT is where some of us want to return 340B’s focus. THAT is why reform is coming!
Ironically, critics of the 340B reform movement – often motivated by self-preservation and protecting their ever-expanding budget and geographic footprint – are quick to attack the idea of the need for reforms. Sadly, they’re also quick to turn their criticism into personal attacks, including questioning the intentions, morals, and character of the people supporting reform. They charge, using Inspector Clouseau “gotcha” style rhetoric, that we’re in the “pockets” of the drug manufacturers because we accept their money to help with our patient advocacy and education (yet there is no “gotcha”, since this information is quite publicly available on our websites, annual tax returns, Guidestar, as well as frequent public commentary).
Isn’t it funny how the “gotcha” mentality cannot accept the obvious, that maybe our interests align with the drug manufacturers because it is in the best interest of patients. Drug manufacturers make products patients want and need. Ensuring funding flows in a way that expands patient access to medications does indeed benefit both patients and the drug manufacturers. It should be noted, this criticism tends to also neglect mentioning the interests of the entities challenging reform: anti-competitive consolidation among hospitals and pharmacies (leaving whole areas without services), increasing profits, paying for salaries unrelated to healthcare, and increasing administrative salaries are all excellent examples of why we’re left asking “Who is actually benefiting from this program?”
The truth of the matter is, aside from a growing list of patients, patient advocacy organizations, and drug manufacturers, there is a growing chorus calling for reform. Academia wants it (NEJM, Penn LDI, USC Schaeffer), economists want it (Nikpay, Gracia), national trade associations want it (NACHC, NTU), policy think tanks want it (CMPI, NAN), and even multiple news media outlets are suggesting it (Forbes, NYT, WSJ). Local activists are also increasingly fed-up with what they’re witnessing (Dinkins, Feldman, Winstead).
Dr. Diane Nugent, Founder & Medical Director of the Center for Inherited Blood Disorders, recently noted an opinion piece in the Times of San Diego, “A September 2022 analysis by the Community Oncology Alliance revealed that some hospitals participating in 340B price leading oncology medications nearly five times more than the price they paid. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions.”
But speaking of deep pockets, isn’t it also an inconvenient truth that the very folks fighting reform, and fighting improving the program so patients can benefit more directly from it, are the same folks financed by big hospital systems, and mega service providers abusing 340B intent?
A question often asked by advocates learning about 340B: “So, exactly how much money are we talking about here?”
Well, we don’t really know…sort of. For Federal Grantees covered under 340B, their grant contracts require accounting of 340B rebates as part of their programmatic revenues. Those revenues are required to be re-invested in the program, which generated the income. This level of transparency is pretty much a “gold standard” that other Covered Entities (less maybe hemophiliac centers) in the 340B space are required to meet. That’s part of why we, and other advocates, are calling on minimum reporting requirements for hospitals, contract pharmacies, and pharmacy benefit managers (insurers covering medications) to begin providing some data. Clearing up the murkiness, if you will. What we do know is drug manufacturers reported more than $100 BILLION in 340B-related sales last year.
That’s concerning especially because “charity care” is declining and medical debt is a growing issue for more and more patients and their families. The Affordable Care Act mandated “charity care”, or “financial assistance”, to be offered by non-profit hospitals seeking to qualify as 340B entities but did not place any definitions behind the mandate, including any “floor” of how much charity care a hospital has to offer.
Now, in all rhetoric opposing any type of transparency in 340B, hospitals tend to conflate their “uncompensated care” and “unreimbursed care” or “off-sets” for public health programs – these don’t necessarily reflect any “charity” being provided to patients. These things should be separated when considering what benefit hospitals provide a community. And under that lens, things get kind of ugly with far too many of the 340B hospitals reporting providing less than 1% of their operating costs as charity. When reviewing how much hospitals write off in bad debt, or going after patients who can’t afford care, often far exceeding those charity care levels, we’re left asking if the “non-profit” designation is really a declaration of concentrating “profits” by way of salaries to top executives rather than formal shareholders?
That bad debt shows up for patients as medical debt. And we need to be very specific here: according to the Urban Institute, some 72% of patients with medical debt owe some or all of that debt to hospitals. Meaning, what we call medical debt is really hospital debt. The situation is unarguably bad. This year alone the Los Angeles County Office of Public Health issued a report outlining for policymakers the role and responsibility hospitals have in driving medical debt and how increasing charity care might stem this problem.
As patients, and frankly as patient advocates who represent thousands like us, medical debt isn’t an issue that can be swept under the carpet. Entire communities avoid necessary care to protect their financial interests. We’ve personally watched our friends open GoFundMe accounts to cover medical expenses. We’ve helped our loved one’s cover food and light bills to not miss a medical bill. We also well recognize how negative credit reporting from medical debt can hurt people from getting rental housing or a car loan, or even simple necessities. And when thinking about how much we don’t know about what’s behind that $100 billion price tag, the fact that patients face these concerns on the regular is pretty obscene.
We do know there are plenty of good actors in the 340B space. Particularly, Federal Grantee Covered Entities, like Ryan White Clinics and AIDS Drug Assistance Programs (ADAPs). And we know they’re generally great actors because of that transparency in reporting and the oversight offered by their grant contracts. Ultimately, we’re not necessarily asking for a whole lot more than that for literally everyone else who stands to make a buck in the chain between drug manufacturers and patients. Indeed, that trust on Federal Grantees, particularly Ryan White Clinics and ADAPs, is part of why drug manufacturers restricting 340B sales held a carve out for these Federal Grantees. (To be fair and without much public fanfare, years ago, we – as in ADAP Advocacy and CANN – helped to negotiate these carve-outs as part of our advocacy. Our relationship with drug manufacturers isn’t a one-way street as detractors might try and sell you on.
$100 billion is a lot of money! Is it too much to ask, “Why aren’t patients benefiting more directly from this ever-growing healthcare program?” Facts show that 340B revenues are soaring year after year, yet against the grim backdrop of consistently declining charity care in the impoverished communities needing the most help. To make matters worse, rising medical debt is crushing families. Patients deserve better. People living with HIV who depend on the RWHAP and 340B deserve better! And that is why we need reform.
Read our policy reform suggestions here.
CDC Publishes New Medical Monitoring Data
On August 22nd, the Centers for Disease Control and Prevention (CDC) published new data from the Medical Monitoring Project (MMP). The MMP is an annual, national survey sample evaluating certain behavioral and clinical characteristics of people living with HIV (PLWH). Particularly, the report now includes certain quality of life metrics and stigma related factors as suggested in the National HIV/AIDS Strategy (NHAS). Data was reported from the 2021 cycle, meaning collected from June of 2021 through May of 2022.These measures relating to stigma and quality of life offer insight as to the experiences of PLWH and potential barriers to care – ranging from housing and food insecurity to mental and emotional health.
The findings were a bit of a mixed bag. NHAS suggests an overall health rating of “good” or “better” among participants should reach 95% or better to consider this metric goal achieved. However, the 021 cycle saw a drop in overall health rating of “good” or “better” from 72% in 2020 to 69% in 2021, the lowest since 2018.
Similarly, the measure of “unmet needs” for mental health services increased from 21% in 2020 to 28% in 2021. This is also the highest rate of unmet mental health services needs since 2017. NASH sets the goal for this metric at 12%. In order to address these needs, federal and state funding designs and initiatives should reflect this priority. Among them, regulatory enforcement on mental health parity among insurance networks and reimbursement rates, especially in Medicaid programs, and public policy efforts aimed at those issues which affect mental health and overall health (like housing and food security and stigma via strengthening of anti-discrimination laws and incentivizing best practices in areas of life affecting people living with HIV such as child welfare programs, education programs, and among family courts). Why?
Among participants, 9% reported experiencing symptoms of major depression within two weeks of taking the survey and 7% reported symptoms of “other depression” in the two weeks prior to the interview. Similarly, 5% of participants reported “mild anxiety” in the two weeks previous to the interview and 8% reported “moderate anxiety” with the same percentage reporting “severe anxiety” during their interviews. In addition to these, 29% of participants reported experiencing intimate partner violence at some point in their lives, with 5% reporting intimate partner violence in the last 12 months and 17% reporting having experienced rape* in their lifetime and 1% within the last 12 months.
The neutral news is that the percentage of PLWH in an “unstable housing” situation has stayed steady from 2020 to 2021 at 17%. Given the economic upheaval of 2020 and continuing through 2021 and 2022, maintaining a rate of housing security is a notable achievement for our housing programs. However, NHAS sets the metric goal at 11%, meaning there’s still plenty of room for improvement in ensuring PLWH are adequately housed. Along these same lines, “food insecurity” also maintained its 2020 rate at 16%. Layered onto the human rights and sheer necessity of food access, many antiretroviral tablet regimens and medications used to treat co-occurring conditions require food in order to be properly absorbed. NHAS sets the goal for this metric also at 11%. If PLWH do not have sufficient, secure sources of nutrition and housing, all other care will fall by the way side. 8% and 38% of participants surveyed reported experiencing homelessness or having their household live in poverty, respectively. 16% of survey participants reported experiencing hunger or food insecurity.
Unemployment among PLWH dropped in 2021 to 15%, just higher than the 14% in 2019. 2020, for obvious reasons related to the emergency phase of the COVID-19 pandemic, saw a dramatic spike in unemployment among PLWH to 18% - far higher than the national average of 13% through 2020. Employment often offers PLWH not only a secure source of income, it also often offers insurance coverage and a pathway to security in housing and food. Strengthening the workforce is absolutely a necessity in achieving NHAS’s goal of at most 8% unemployment among PLWH. 39% of participants surveyed reported being unemployed or lacking an ability to work.
Lastly, and likely the most heartbreaking data from the survey, trends in stigma have reversed course from a 3% reduction in 2020 at 28%, increasing to 29% in 2021. Ensuring PLWH are not stigmatized when in care, at work, seeking housing or education, or when faced with those in positions of authority in other areas of life is critically important to ensuring we reduce experiences with harmful stereotypes. We can start by defining stigma in concrete terms and advocating for policies addressing those aspects of life for PLWH. While the NHAS sets the goal for this metric at 16%, even that’s still an unacceptably high level of stigma for the 1.2 million people living with HIV in the United States.
Payors participants utilized was highest for those enrolled in Ryan White coverage at 47%, Medicaid covered 43%, private plans covered 42%, 29% were covered by Medicare, and 9% reported being uninsured. 66% of participants reported viral suppression at their most recent clinical test with 62% reporting “sustained” viral suppression. 95% received outpatient care, 71% reported being retained in care, 81% reported they did not miss their HIV-related provider appointments, and 80% reported being prescribed antiretroviral medications. Reasons ever missing doses were reported as follows: 65% simply forgot to take their medications at some point, 42% reported a change in routine disrupted their medication cycle, 40% reported falling asleep early or oversleeping as a cause to miss a dose, 17% reported feeling depressed or overwhelmed, and – not shockingly but it really should be – 16% had a problem getting their HIV medication prescription filled or refilled.
MMP sites are located in 16 states and 6 separate funding jurisdictions. Participants gender demographics were identified as 23% cisgender women, 75% cisgender men, and 2% “transgender” with no differentiation among identity or sex assigned at birth for transgender participants. 55% of participants were older than 50, 20% were between the ages of 40-49, 18% were between the ages of 30-39, 7% were among those aged 18-29, and no participants younger than 18 were included. 43% reported their sexual identity as heterosexual or straight and 43% reported identifying as lesbian or gay, 10% reported identifying as bisexual, and 4% reported identifying as “another sexual orientation”. Lastly, the racial make up of the cohort was reported as follows: 41% African American/Black, 28% White, 24% Hispanic/Latino, 5% multiracial, 1% Asian, less than 1% American Indian/Native Alaskan. While the report was analyzed under a lens of accounting for certain skewed demographic participation, the limitation of experience should be noted.