What’s Needed to Fix a Vital Drug Discount Program

By: Brandon M. Macsata, CEO, ADAP Advocacy Association & Guy Anthony, Founder & President, Black, Gifted & Whole Foundation

****Reprinted with permission from POZ****

Thirty years ago, when Congress passed the Public Health Service Act, no one could have imagined that section 340B of the law would become the lightning rod that it is today. The little-known provision created a program to help America’s safety net health care providers bring affordable care and discounted medicines to vulnerable, low-income patients. 

Photo Source: POZ | iStock

The initial concept was simple and effective. Pharmaceutical manufacturers provide steeply discounted drugs to hospitals, providers, and clinics that serve uninsured and underinsured patients living with HIV/AIDS, and safety net providers dedicated to reaching the most vulnerable and underserved communities. The support that the 340B program provided to Ryan White Clinics and hemophilia treatment centers was critical in addressing the HIV/AIDS crisis through the 1990s. Today, when people living with HIV can successfully manage the disease with highly effective therapies, it remains essential.

But the program and the true safety-net clinics that rely on it is teetering on the brink of collapse due to statutory silence in key areas. It turns out that the attraction of using significant savings on medicines to boost profit margins has been irresistible to some for-profit entities, at the expense of the safety net. The for-profit entities dipping into the 340B program’s discounted prescription drugs now include, among others, well-resourced hospitals in wealthier zip codes, pharmacy benefit managers (PBMs), and a vast network of contracted pharmacies (also largely located in wealthier zip codes). The numbers on this point speak volumes: 340B discounted drug purchases amounted to $38 billion in 2020, more than 15 times what it was in 2005. As Congressman Bucshon noted, wouldn’t you expect a 15x increase in the amount of charity care that is available in this country?

The realities of how the 340B program is currently implemented is a clear indication that stronger accountability and transparency are urgently needed so that the program can begin to work as intended, and patients don’t continue to get left behind. Abuses of the program have been exhaustively documented by government watchdogs and others including analysis by an advocacy group for cancer patients that found that hospitals are overcharging patients for a common breast cancer drug. The research found that hospitals pay a discounted price of just over $43,000 for a year’s supply of the drug,   while charging patients over $217,000 for the same medicine, reaping a profit of more than $173,000 from just one patient, thanks to the program designed to help the nation’s poorest citizens. 

Patients are bearing serious consequences from the lack of clarity in the 340B program and the loss of critical resources safety-net providers depend on. As organizations that provide essential services and education for the HIV/AIDS community, we know this program must be better defined if it is to work as intended. We also know that Congress has a central role to play in making that happen. 

We can only achieve changes that work in the interest of the safety net if the diverse 340B community works together, rather than at odds with itself. That’s where the newly-formed Alliance to Save America’s 340B Program (ASAP 340B) comes into play. The Alliance’s 10 policy principles provide a critical foundation for Washington decision makers to change the trajectory of the program and improve administration and oversight at the federal level. The Principles are designed to ensure greater transparency and accountability; determine a “patient definition” with with stronger safeguards; establish clear criteria for 340B contract pharmacy arrangements to improve access; prevent middlemen and for-profit entities from profiting off the 340B program; and update and strengthen 340B hospital eligibility requirements.

Photo Source: ASAP 340B

Inaction will – not could but will – very soon have serious ramifications on the care that our community receives. Yet despite the diverse organizations that have come to the table to bring about change, not everyone agrees. A cacophony of voices – including some from the HIV community – has expressed concern or displeasure with the idea of bringing ideas to the table that would enhance transparency, accountability, and most importantly, deliver long-time certainty to the program. But notably, no comprehensive, viable alternatives have been offered. 

Congress and the administration have made it clear that making prescription drugs more affordable should be a major public health priority. Fixing the 340B program can move the needle on that goal, bringing health care affordability to our nation’s most underserved patients and communities.

This opinion piece was also published on June 7th in POZ.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Did South Carolina Just Weaken Patient Choice Protections for Specialty Drugs?

By: Ranier Simons, ADAP Blog Guest Contributor

An undeniable fact with largely universal consensus is that the United States needs healthcare reform. Healthcare reform is an overhauling of the healthcare system to achieve what the Institute for Healthcare Improvement describes as the Triple Aim: “improving the patient experience of care (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of health care.”[1] The Affordable Care Act (ACA) is the most recent attempt to reach the Triple Aim by increasing insurance access, mandating levels of quality, and trying to make healthcare more affordable. The challenge of healthcare reform is that healthcare is a system. By definition, a system has moving components that not only move independently but also are interdependent upon other parts of the system. Regarding healthcare, the moving parts of the system are smaller systems. South Carolina recently attempted to make some positive changes to the healthcare infrastructure in that state, though it is unclear if all the changes will actually benefit patients.

Photo Source: Greenville Legal

It is important to remember that regulation is one tool used to attempt the improvement of the many U.S. healthcare system components. Through legislative regulation, lawmakers try to create frameworks to optimize how various healthcare system component’s function. A significant component of healthcare is prescription medication. Pharmacies, pharmacy benefit managers (PBMs), and insurance plans are several players in the prescription medication system. Presently, the costs and availability of drugs are primarily controlled by PBMs. Insurance companies employ pharmacy benefit managers who control which drugs appear on plan formularies, negotiate the prices insurance plans pay for prescriptions, decide which pharmacies can participate in a plan’s network, and more.[3,5]

While many components within the U.S. healthcare system operate under detailed and enforced regulation, PBMs do not. They are largely unregulated. To maximize their profits, they participate in multiple practices that create challenges for insurance plans, pharmacies, and ultimately patients, driving up costs and creating inefficiencies in patient care.[3,5] South Carolina has been working through legislation to curtail and regulate the activity of PBMs - including Senate Bill 520 (SB520), part of the Pharmacy Audit Protection Act - which was recently passed by the state legislature.[2]

One of many excessive practices by PBMs to drive profit is pharmacy audit. A pharmacist with over 30 years experience providing care to patients living with HIV/AIDS summarized, “Pharmacists are constantly being audited by strong-arm PBMs. They often go after the high-cost drugs and deny claims for minor infractions. It’s a bullying tactic.” SB520 aims to protect pharmacies from unjust audits by PBMs. The bill defines explicitly the structure of what entity can be designated a PBM; it explains what PBMs operationally can and cannot do, defines the rights of pharmacies in general and in the face of a PBM audit, gives patients freedom of choice in utilizing in-network pharmacies, and much more. PBMs use numerous abusive audit practices to drive profit, including audit fees, denying claims for minor clerical errors forcing pharmacies to pay back money for drugs they were reimbursed, and making it difficult for pharmacies to re-bill PBMs after winning audit appeals.

Photo Source: Framework LTC

The bill is essentially a step in the right direction. However, multiple payers lobbied to add verbiage potentially adversely affecting HIV patients and others. Section 38-71-2245, subsection (A) states: “A pharmacy benefits manager may neither limit an insured from selecting an in-network pharmacy or pharmacist of the insured's choice nor deny the right of a pharmacy or pharmacist to participate in a network if the pharmacy or pharmacist meets the requirements for network participation set forth by the pharmacy benefits manager, and the pharmacy or pharmacist agrees to the contract terms, conditions, and rates of reimbursements.”[2]  This section protects patient choice of pharmacists. 

Payers asked for the following verbiage added to the section: 

“Notwithstanding subsection (A), a pharmacy benefits manager may, for specialized delivery drugs, specify requirements for network participation that: (1) directly relate to the ability of the pharmacy or pharmacist to store, handle, or deliver a prescription drug in a manner that ensures the quality, integrity, or safety of the drug, its delivery, or its use; or  (2) relate to quality metrics that affect a pharmacy's or pharmacist's ability to participate, provided that the pharmacy benefits manager applies such terms equally to all network participants. (C) For prescription drugs that qualify as a high-cost prescription drug, subsection (A) of this section does not apply to a pharmacy benefits manager. A high-cost prescription drug is defined as a prescription drug whose current or prior year's annual average wholesale price exceeded 300 percent of the Federal Poverty Level for a single-member household. (D) A pharmacy benefits manager must provide notification of any changes to all applicable specialized delivery drug lists and high-cost prescription drug lists and must make such lists available on a website and upon request to participating pharmacies. A pharmacy may appeal a classification determination to the Department of Insurance.”[2]

The verbiage states that patient choice protections do not apply to specialty or high-cost prescription drugs. In section 38-71-2200, the bill defines specialized delivery drugs as “a prescription drug that meets a majority of the following criteria, as set forth by the manufacturer, FDA, or other applicable law or regulatory body and: (a) requires special handling or storage; (b) requires complex and extended patient education or counseling; (c) requires intensive monitoring; (d) requires clinical oversight; or (e) requires product support services; and the drug is used to treat chronic and complex, or rare medical conditions  (i) that can be progressive; or (ii) that can be debilitating or fatal if left untreated or under-treated.”[2]

Given the broad definition of specialty and high-cost prescription drugs, the bill allows PBMs to manipulate how HIV antiretrovirals and related treatments are filled. The pharmacist consulted on this issue also explains, "It’s a way for PBMs to mandate that these prescriptions need to be filled from their central mail pharmacies. Since most HIV ARVs are oral and do not require special handling, access has commonly been allowed at retail. The high cost is what’s driving this change. Also, most independent pharmacies don’t mind not having to fill these drugs because of the high cost. For HIV-focused pharmacies, these prescriptions and patients will no longer have access to trained pharmacists and relationships with providers… will all go to mail and automation.” 

He further explains that: “In exchange for fewer audits on specialty drugs, since the retail pharmacies won't be filling them anymore, the managed care organizations will allow more access to more regular prescriptions at retail pharmacies, a move that a lot of non-specialty pharmacies like because it allows them to serve more patients. They’re trading away HIV patients for more ‘non-specialty’ patients.”

Photo Source: SNF Solutions

The bill's definition of “specialized delivery” drugs affects other types of drugs as well. Using the example of antibiotics for a UTI for an elderly person, Jen Laws, President & CEO of Community Access National Network (CANN), explains: “Under the requirements set forth, most antibiotics lose efficacy when exposed to high heat, might require education as to contraindications for patients with other co-occurring conditions, will require monitoring for clearance of infection, and these types of infections can be progressive or debilitating in elderly patients. And while this is an extreme example, it is possible under the bill as written. Given payer willingness to abuse carve-outs and loopholes in laws, it's egregious to define ‘specialty’ so broadly, especially as medicine becomes more and more personalized.”

Increased financial burden on HIV patients and providers is another bill outcome. ARVs are not always defined as specialty drugs on formularies, and thus, many times, they are on lower tiers of formularies that only require cost-sharing of fixed lower copays. Since the bill allows PBMs to define all ARVs as specialty drugs, they can move them to higher formulary tiers, which have much higher cost-sharing practices, such as significantly higher copays and coinsurance. This creates a significantly increased out-of-pocket financial burden on patients and covered entities that are covering the 340B patient copay cost.  

Compounding the increased financial burden is the usage of copay accumulators. Patients in the past who used manufacturer copay assistance programs could apply the copay card payments to their insurance deductible and out-of-pocket costs. Presently, many insurers use copay accumulators, which allow the copay assistance programs to pay the copays but do not allow the payments to count towards deductibles or out-of-pocket expense limits. Thus, the insurance companies are essentially being paid twice by requiring the insured to still must pay their deductibles and out-of-pocket limits after exhausting copay assistance cards. Additionally, patients are in danger of being unable to afford their medication since they would be responsible for paying the full price of their medications after the copay assistance was exhausted up until the limits of completely paying their deductibles.[4]

This bill is an example of the challenges of healthcare reform. It is easy for well-intentioned legislation to be tainted by opposing interests. It is imperative to be vigilant about whom we select as legislative representation and stay informed about legislation being written that affects our daily lives.

[1] Institute for Healthcare Improvement. (2023). The IHI Triple Aim. Retrieved from https://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx

[2] South Carolina State House. (2023). S0520. Retrieved from https://www.scstatehouse.gov/sess125_2023-2024/bills/520.htm

[3] Royce, T., Schenkel, C., Kirkwood, K., Levit, L., Levit, K., Kircher, S. (2020). Impact of pharmacy benefit managers on oncology practices and patients. JCO Oncology Practice 16(5) 276-284. DOI: 10.1200/JOP.19.00606

[4] National Conference of State Legislatures. (2023, February 23). Copayment Adjustment Programs. Retrieved from https://www.ncsl.org/health/copayment-adjustment-programs#:~:text=When%20a%20patient's%20health%20plan,out%2Dof%2Dpocket%20maximums

[5] Healthcare Value Hub. (2018, January). Pharmacy benefit managers: Can they return to their client-centered origins? Retrieved from https://www.healthcarevaluehub.org/advocate-resources/publications/pharmacy-benefit-managers-can-they-return-their-client-centered-origins

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

Together, We Can Lower Out-of-Pocket Costs & Increase Access to Healthcare

By: Amy Niles, Executive Vice President, PAN Foundation 

Your voice as a patient advocate, and the voices of the patients you support, are critically important when it comes to health policy. You have experiences to share, perspectives to provide and valuable input on proposed policy solutions. Healthcare policy is only effective if it addresses patient needs and improves access to and affordability of treatment. 

That is why the PAN Foundation has launched its online advocacy action center – to provide a central place for information about effective ways to communicate with elected officials, and importantly, to be a key destination for campaigns and advocacy initiatives focused on improving access to and affordability of treatment. 

Photo Source: PAN Foundation

Our first campaign addresses the need to lower out-of-pocket costs for prescription medications in Medicare Part D. In one click, we make it easy for you or your constituents to send an email to their elected officials, letting them know that relief from out-of-pocket costs for millions of Americans is desperately needed – NOW! Information about this campaign is included below. 

My ask of you?

As soon as you can, please encourage your patient communities to visit PAN’s advocacy action center, learn more about this campaign, and take immediate action by writing their members of Congress. It is easy, important, and needed as we head into the fall months.

If you need any assistance or have ideas for encouraging patients to share their stories, and their voices, do not hesitate to reach out to me. Learn more at https://www.panfoundation.org/become-an-advocate/.

Thanks, as always, for all you do. 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

COVID-19 Essential Patient Resource: Pharmacists

By: Glen Pietrandoni, RPh, AAHIVP, VP Industry Relations, AVITA Pharmacy

Pharmacists have been on the front line of the COVID-19 response to ensure patients remain safe and continue to receive essential medicines on time. Pharmacists are the most easily accessible healthcare professionals in the community. No appointments are necessary, and pharmacists don’t charge to speak with them!

Since the pandemic began, pharmacists have spent a lot of time educating people about COVID-19, and reinforcing messaging about how to reduce the spread, social distancing, hand washing, masks, etc. This is especially important where some may think they don't have to worry about the virus, or if it is not yet present in their community. Let’s face it, there’s a lot of mixed messages around the country. Pharmacists can help provide trusted information to help you and your family, absent of political views or stigma.

Forty years of helping people thrive within the context of HIV treatment and prevention gives pharmacists and patients an advantage today as we have learned how to care for each other during difficult times in the past. Most importantly, the need to continue a high rate of adherence to medication does not change because of this disruption in our daily routine due to the coronavirus. We are all champions for U=U. To stay undetectable during a pandemic of this new virus, we cannot let up on being adherent to the drugs for the old virus. YOU CAN DO THIS, and pharmacists can help.

I have often written and spoken about the importance of having a relationship with your pharmacist and pharmacy staff. That could be as simple as making a point of engaging in a simple conversation, for instance, asking their name, or asking if you can ask questions from time to time.  I’ve mentioned in the past that it’s more common to know the name of the person that cuts your hair or the barista at Starbucks, than to know the name of your pharmacist. If the pharmacy you are using pushes back or doesn’t make that easy for you, then you might want to consider looking for a pharmacy/pharmacist that understands HIV and YOU. You deserve that courtesy!

Let’s talk about how pharmacist can help you during the COVID-19 pandemic and beyond.

Pharmacies have remained open during the outbreak

You may need to check if the operating hours have changed, but pharmacists are considered essential workers and have been eager to accommodate unusual circumstances when possible. Try to plan ahead for refills if possible, as the pharmacies might be busier than usual.  Also, if your insurance or ADAP (AIDS Drug Assistance Program) plans require renewal or recertification, check into this before you are out of medication to avoid delays. Many pharmacists can help you if you have questions. With COVID-19  exceptions are being made to allow grace periods and extensions.

Consider requesting 90-day refills if the insurance coverage or ADAP allows.

Pharmacies often offer delivery options

Pharmacies continue helping people – particularly the most vulnerable – get prescriptions filled online or remotely, and have medications delivered to your home. Check with you pharmacy about options and potential cost of delivery.

By helping you stay healthy

Pharmacists can speak with you regarding your medication questions because they can see your prescriptions from all your providers in one place. Pharmacists can help you at times when you need prescription refills by contacting your doctors for you. During this time, providers are also very busy and difficult to reach. Pharmacists work closely with providers and could save you some time and stress.

Did you know you pharmacist can synchronize your medications to minimize the numbers of trips to the pharmacy or deliveries? Why not get all your medications at one time. That you also help you stay adherent and not run out of medication.  Makes sense! Another part of the pharmacists’ job is to check for drug interactions, monitor for potential adherence challenges and help you manage side effects or adverse reactions. 

Many pharmacies have apps to help people manage their health and medications. These have become more useful during COVID-19, allowing patients to manage medications through alerts for refills and even dosing reminders. We’re all a little more stressed than usual, so it might be worth trying these out.

By helping you save money 

Some people have prescription copays (money due to the pharmacy paid by the patient). It’s a good idea to ask you pharmacist (you know their name now, right?) if they are aware of ways to save money on out-of-pocket costs.

Now that you know your pharmacist’s name, it will be nice to speak to a friendly voice every month or so. In this time of COVID-19, isolation and depression can be a concern for so many people. As a pharmacist myself, I know that building relationships with my patients over time allowed me to check in with them monthly. In that interaction, our relationship provides some comfort and opens the door for questions and conversations. My favorite question to my patients were things like “how’s your dog?”, or “do you have a restaurant recommendation?” In doing this, I get a sense of how my patients were doing emotionally and is an indirect way to check on their well-being. Of course, with coronavirus, it is so important to stay connected, the questions are more directed toward staying safe and taking precautions. Because the relationship exists, this is an easy pivot based on mutual trust.

At this time, we can all use a helping hand and a friendly voice. Pharmacists can be that someone that fits this role during covid and long after.

Click here to download the "Talking to Patients About Access to Medication - A New Resource" published by the Community Access National Network (CANN) and the Partnership for Safe Medicines (PSM).

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Surprise Medical Bills in the Age of the Coronavirus

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Many of America’s citizens consider their country one of the most advanced in the world. Despite this advancement, healthcare in the U.S. has sunk to 27th in the world (Business Insider). Unexpected medical bills for many families in the U.S. are problematic because they have no way to address them. The ongoing novel Coronavirus ("COVID-19") pandemic only exacerbates it.

Recent statistics revealed 35% of adults in America are worried about unexpected medical bills, with 22% worried about both health insurance and prescription drug costs (KFF).

Photo Source: Center for Public Policy Priorities

Out of network providers are often the culprit of these surprise medical bills for insured citizens. According to KFF Health Tracking Polls, 65% of the public say they are somewhat worried about unexpected medical bills. 35% say they are extremely worried.

With the recent spread of COVID-19 to Europe and America, questions have been raised about the affordability of testing and treatment of the virus.

Families who work hourly for family income are extremely susceptible to surprise medical bills in relation to COVID-19. With quarantines, restaurant shutdowns and other businesses suspending operations in light of the pandemic, many are left without work, and subsequently without an income.

Most all U.S. insurance companies have agreed to cover costs of COVID-19 testing and treatment, but those who are uninsured and in a high-risk category such as HIV positive persons are at the mercy of the healthcare system.

One Miami resident checked himself into the hospital after a work trip to China, for fear of possible exposure to the virus.

“He asked to be first tested for the flu before getting a CT scan to screen for coronavirus because of his limited insurance plan. He did have the flu, which meant no further testing for coronavirus, but he told us that the whole hospital visit cost $3,270, according to a notice from his insurance company,” (Business Insider).

A trip for the flu is upwards of $3,000 for the average person. A person who visits the ER with moderate severity to high severity of COVID-19 could face hospital bills ranging from $441-$1,151. A bill this high and unexpected could set back the average American citizen for months.

For insured persons, out of network costs could cripple even the most financially secure families. Jennifer Finney Boylan is a contributing opinion writer for the New York Times recently wrote on her $145,000 surprise medical bill, due to an out of network provider. (New York Times)

“I contacted our doctor the day after we got our $145,000 bill and he very kindly told me not to worry. “Doctor’s orders!” he added, which I thought was nice. Later, another doctor in the practice told me that even when procedures are pre-authorized (as my child’s was) insurers often deny them anyway. His understanding was that insurance companies often respond to preapproved claims with denial and delay, hoping that consumers will somehow just give up,” Boylan said.

While surprise medical bills may knock American citizens off their financial track for a while, Boylan’s story proves that some are repairable. With the inevitable spread of COVID-19 through the U.S. in the upcoming months, hopes of many are that out of network costs will be waived to fight the virus and help the more financially fragile of us all.

References:

• Bendix, A. (2018, September 27). The US was once a leader for healthcare and education - now it ranks 27th in the world. Retrieved from https://www.businessinsider.com/us-ranks-27th-for-healthcare-and-education-2018-9
• Boylan, J. F. (2020, February 19). My $145,000 Surprise Medical Bill. Retrieved from https://www.nytimes.com/2020/02/19/opinion/surprise-medical-bill.html
• Hoffower, H. (2020, February 29). Coronavirus testing is free, but the hospital trip may set you back thousands. One graphic breaks down potential costs. Retrieved from https://www.businessinsider.com/how-much-does-coronavirus-treatment-cost-cdc-health-insurance-2020-2
• Lopes, L., Kearney, A., Hamel, L., & Brodie, M. (2020, February 28). Data Note: Public Worries About And Experience With Surprise Medical Bills. Retrieved from https://www.kff.org/health-costs/poll-finding/data-note-public-worries-about-and-experience-with-surprise-medical-bills/?utm_campaign=KFF-2020-Health-Costs&utm_source=hs_email&utm_medium=email&utm_content=84040903&_hsenc=p2ANqtz-9QXfClhIkboujL5y5GF7evYHuGhjVSsvRW9KkkIH0tEGYuc7-VaNrvabHd3r-GyjNBOLUJOKsL8fDWEhhoQxixWSJ9DQ

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Rx Drug Coupon Concerns Pit Prices Against Patients

Guest Blog By: Marcus J. Hopkins, Blogger

Drug manufacturer coupons have increasingly become a popular method of reducing the price consumers pay for their medications. Insurers, Pharmacy Benefits Managers (PBMs), and other payors, however, argue that these cost saving tools actually drive prices upward and result in patients choosing expensive brand name drugs over less expensive generic alternatives, essentially costing the payors more money, in the long run. As a result, some payors are taking the extraordinary step of no longer counting drug coupons toward patients’ out-of-pocket costs and deductibles, meaning that once patients use a coupon, they’ll be left to pay the remaining cost of the drug out-of-pocket.

When looking at how and when these coupons are used, however, Health Affairs = a leading journal in health policy thought and research – found that just 21% of coupons used in the 200 highest expenditure drugs of 2014 had a direct generic substitute, while another 28% had an “imperfect substitute.” The remaining 51% of drug had either no generic substitute or only branded alternatives (Van Nuys et al., 2018).

For patients living with HIV (and, more recently, Hepatitis C), the past decade has been revolutionary in terms of the medications that have been made available to treat the disease. In 2007, most patients began treatment using a two- or three-pill regimen with various storage requirements. A year earlier, the first single-pill regimen, Atripla (Gilead), was approved by the FDA for the treatment of HIV.  In 2017, virtually patients begin HIV treatment with a single-pill regimen. The sad reality, however, is that there are no generic substitutes available in the United States for HIV drugs, and manufacturer coupons that reduce co-pays for them play a vital role in determining whether or not patients can afford the lifesaving medications they need.

“Consumers with life-threatening conditions are caught in the crossfire of an ongoing battle between insurers and drug companies over drug pricing. No matter who wins the battle, the casualties will be the patients, taxpayers, and the general public,” says Eddie Hamilton of the Columbus, Ohio-based ADAP Educational Initiative.

Photo Source: Consumer Reports

He is correct. In the rush to lower expenditures in the post-Affordable Care Act (ACA) market, insurers have increasingly begun weaponizing their drug formularies – the list of drugs payors will cover and for how much – against manufacturers to force lower pricing agreements, all of which are confidential under existing Trade Secrets laws. Placing brand name drugs in higher-cost tiers has been a relatively ineffective weapon when it comes to lowering overall prices, but has been an effective barrier to treatment for many patients living with HIV and other chronic illnesses for which there are few, if any, generic and/or effective alternatives.

This latest salvo against drug manufacturers will ultimately end up hurting consumers more than it will lower expenditures for insurers.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Do Consumers Deserve Rx Savings? (Part 2)

Guest Blog By: Marcus J. Hopkins, Blogger 

In last week’s guest blog, Do Consumers Deserve Rx Savings?, I discussed the various issues surrounding pharmaceutical pricing, as well as the possibility of the Centers for Medicare and Medicaid Services (CMS) switching where drug rebates are applied by requiring sponsors to pass on a minimum percent of the cost-weighted average of rebates on to consumers. Essentially, who deserves the drug rebates more: health insurance companies, pharmacies, and pharmacy benefit managers (PBMs), or consumers?

Photo Source: prweb.com

In November 2017, CMS put out a Request for Information (RFI) about a proposed rule that would revise the Medicare Advantage program (Part C) and the Prescription Drug Benefit program (Part D) that would require payors to pass on a percent of the drug rebates negotiated with pharmaceutical manufacturers on to consumers at the Point of Sale (POS). This would, ostensibly, lower the out-of-pocket costs to consumers by reducing the amount they pay at the register when purchasing a medication during the deductible phase of their insurance plan, when they pay the full cost of the co-pay/drug.

A personal example of this is my prescription for the HIV combination drug, Genvoya (Gilead). Under my current insurance plan, Highmark BlueCross/BlueShield (BC/BS), my monthly co-pay for this drug is $250 until I reach my deductible and/or out-of-pocket maximum. Luckily, West Virginia’s Ryan White program uses the Part B AIDS Drug Assistance Program (ADAP) funds to pay my co-pay, or I’d be considerably financially stressed, each month. Highmark BC/BS has negotiated a price discount for this drug and may also receive rebates that they can apply to each purchase of the drug each month (neither of which are publicly available per the trade secrets laws I mentioned, last week).

Now, imagine if I, as a consumer and client of Highmark BC/BS went to pick up my medications (or ordered them over the phone to be shipped, as is the case), and instead of the normal $250 co-pay, I received the rebate (let’s say $50) rather than Highmark BC/BS receiving it at the end of the month. My co-pay would be reduced to $200 (which is still a stretch if you’re on a tight budget), and Highmark BC/BS doesn’t. Any consumer who cares more about their pocketbooks than insurance companies’ profits would jump at the chance to pay less.

And that’s where Highmark BC/BS, represented by America’s Health Insurance Plans (AHIP) disagree. Despite any discounts they may negotiate with Gilead over the cost of Genvoya, they have also grown to expect access to significant drug rebates on top of not having to pay the list prices. So, let’s say they pay for 100 fills of Genvoya (which comes in a standardized bottle, so the number of pills is irrelevant) at a 50%-60% discount off the list price (let’s use $250/bottle as that cost). On top of that, they also have negotiated to get a $50 rebate per bottle sold. They would spend $25,000/month on those 100 bottles and expect to receive $50/bottle rebate for an extra $5,000/month back into their pockets. Essentially, they’re paying $20,000/month, and pocketing $5,000/month.

It isn’t just insurance companies and PBMs who are doing this – it’s also certain pharmacies and AIDS Service Organizations (ASOs) who operate their own pharmacies.As an ADAP program, they negotiated significantly lower prices than even the health insurance programs and get rebates back on top of it. It is no wonder, then, that these organizations are staunchly against passing on these rebates to consumers: they do their financial planning based upon the belief that they’re going to receive these rebate dollars. They argue that consumers will actually pay more if they don’t get the rebates. They argue that, because they know that they will pass along those costs to consumers, if they don’t get their way.

Pharmaceutical companies, ironically, are arguing that consumers should receive the rebates, rather than their opponents. This may have to do with the fact that there have been several Congressional hearings and inquiries into the considerably overinflated prices of their drugs. Therefore, it behooves them to appear to support anything that would ostensibly save consumers out-of-pocket costs. Moving these rebates to the POS would, essentially, cut out the middlemen in the process – the payors – and would allow those rebates to passed directly to the register when you buy your drugs. 

Photo Source: Actionable Books 

So – do consumers “deserve” this? Yes. But, that’s not all they deserve; it’s not the single solution to the astronomical costs of drugs. It has to be part of a bigger plan to reduce costs. There need to be multiple rebates at play – the ones for the payors and ones for consumers that they can receive directly to further lower the price. So, on top of the negotiated $50 back foe Genvoya on the payor side, I’d like to stack on top of that another $10-$30 consumer rebate I can download off their website or receive in an app that can be activated at the POS to take my $250 co-pay down to potentially $180. That would be much more manageable, particularly for people on fixed incomes. It’s still not great, and an overall overhaul of how drug prices are determined is still needed. But, it’s something.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Drug Importation Policy is a Hard Pill to Swallow

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

When I first heard the news that Congress was considering legislation that would allow prescription drugs to be imported from abroad, I was honestly quite shocked. I know firsthand how such policy can negatively impact consumers who decide to purchase drugs from abroad. The potential consequences are quite daunting.

In 2002 (just shy of my 30th birthday), I was diagnosed with HIV. When my doctor told me the news, a hundred questions came to mind all at once. What was my long-term prognosis? What types of medications would I have to take? Who could I turn to with my questions about life with HIV?

(Editor's Note: The photo of me was taken in 2002 on Easter Sunday during the time that I was importing my HIV medications. At the time, I was still quite sick after experiencing my acute seroconversion. In fact, in this photo my two best friends are literally helping me stand up, and they made me look "presentable" with some make-up. The benefits of rooming with two wonderful women who took care of me.)

What happened next directly shaped my viewpoint of the dangers associated with importation.

I ordered medications from an online Canadian pharmacy. To this day, I have no way of knowing where the drugs were made or if they contained the active ingredients I needed to effectively treat my condition.

At the time, I opted not to consult my physician in the process. Due to my insurance coverage, my out-of-pocket cost was $1,300 during the second month of treatment. For two months, I received medications via mail from Canada. Honestly, I didn’t even entertain the idea of whether the medicines were real or fake.

Fortunately, my doctor intervened and advised me of the reality of what I was doing. She told me that drugs purchased through online channels are often counterfeit and most likely do not contain any ingredients that help patients. In many cases, the ingredients can be deadly. Without even knowing it, I was rolling the dice with my health and safety. It was an eye opening intervention and one that too few patients ever experience before irreparable damage has been done.

Without question, we need to address the issue of rising health care costs in the United States, which greatly contributes to patients buying medicines online. However, legalizing importation isn’t the solution we need. It will undoubtedly lead more patients to risk their health and, ultimately, their lives through online drug purchases.

Consider the following: The World Health Organization estimates that 10 percent of medicines across the world are fake. In some parts of the world, this number is as high as 30 percent. In 2015, Interpol confiscated nearly 21 million fake medicines, a significant increase over the previous year.

As a society, why would we take our guard down when the threat is so high? As someone who is informed on health care issues (even at the time of my diagnosis), my search for Canadian pharmacies did little to warn me against the dangers. I had little knowledge or available information when I ordered medications from Canada.

Rather than open the floodgates to unregulated medicines, we should be doing more to ensure the safety and integrity of our drug supply. Last month, former FBI Director Louis Freeh released a report highlighting the incentives that drug importation would create for criminals who are actively marketing to consumers in the U.S. and the burden it would place on law enforcement who protect our drug supply.

Among his recommendations to be proactive on the issue, Mr. Freeh urges policymakers to conduct a detailed assessment of law enforcement’s readiness and ability to get in front of the threat that exists. I completely agree with Mr. Freeh - this should be our focus.

As we strengthen our defenses, we must also prioritize patient education and engagement initiatives to ensure that we’re deterring importation from the moment of diagnosis. The reality is that a number of online pharmacies with a Canadian flag attached to them are merely front doors for smugglers operating in countries across the globe.

There are viable ideas to combat the rising cost of healthcare – including prescription medications – but importation is not one of them.

Over the past two decades, we’ve made significant progress against HIV/AIDS. Today, there are medications available that we didn’t have just a few years ago. In fact, recent studies have shown that people in North America and Europe who are infected with HIV and who begin treatment with a triple-drug cocktail can expect to live nearly as long as people who aren’t infected by the virus.

Having lived with HIV for nearly 15 years, I know how important medicine is in achieving a sense of normalcy again. If we embrace drug importation, we’re sending a signal to patients across the country that their health and safety don’t matter. Lawmakers should not be playing a game of chance when patient lives hang in the balance.

This opinion piece was also published in the August 11th edition of the Washington Blade.

2017 National ADAP Monitoring Project Annual Report

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

On May 18th, an analysis of the AIDS Drug Assistance Program (ADAP) was released by the National Alliance of State & Territorial AIDS Directors (NASTAD). The 2017 National ADAP Monitoring Project Annual Report tracked state-by-state programmatic changes, emerging trends, and latest available data on the number of clients served, expenditures on prescription drugs, among other things.

The report, which is published annually by NASTAD, provides stakeholders an important snapshot into ADAP-related data, information, and trends. This year's report focuses on several areas, including:

• The importance of the Ryan White Program and ADAP (p. 6)
• What does it take to achieve viral suppression (p. 20)
• Comprehensive care for people living with HIV/AIDS (p. 42)
• Who benefits from services (p. 58) 

Upon releasing the 2017 National ADAP Monitoring Project Annual Report, Murray C. Penner, NASTAD's executive director, stated the following:[1]

"Over the course of time, there have been significant shifts in funding and client needs; ADAPs have worked to meet those needs, however, have sometimes found themselves unable to serve all those in need of services. Lessons have been learned from these circumstances and ADAPs continue to look to identify how they can meet client need and ensure program sustainability. At a time now when ADAPs are documenting program stability, it is imperative that ADAPs look back on how challenges were resolved and look to the future of client needs and determine ways to prepare for the future. ADAPs are at an unprecedented juncture of being able to look to target resources to populations that need them most, to partner with the RWPB to ensure that the whole client’s needs are met, and to identify ways to bolster treatment for individuals’ health."

The 2017 National ADAP Monitoring Project Annual Report overall yielded some very compelling data on the success of the AIDS Drug Assistance Program nationwide in 2016. Some key points are:

• ADAPs provided medications to 225,517 clients in calendar year (CY) 2015, a 235% increase in utilization over the last 10 years;[2]
• The majority (77%) of all clients served by ADAPs in CY2015 were reported as virally suppressed, de ned as having a viral load that is less than or equal to 200 copies/mL;[3]
• Twenty-eight (28) states contribute funding to their ADAP budget.[4]
• Thirty-eight (38) states receive drug rebates to their ADAP budget.[5]
• Overall, nearly 98% of Part B and ADAP budgets are allocated to program services; only 2.2% of Part B and ADAP funding is used to administer the program;[6]
• The majority of ADAPs pay premiums (84%), deductibles (84%) and prescription co-payments/co-insurance (94%) on behalf of eligible clients.[7]
• Forty-three (43) ADAPs reported using funds for insurance purchasing/continuation, representing $161.8 million in estimated expenditures (10% of the ADAP budget at that time) for 30,621 ADAP clients, with an average cost per client of $5,284.[7]

Accompany this year's report are two infographics. NASTAD used one infographic to provide an analysis on ADAPs with the highest rates of viral suppression. Download the infographic, Key Characteristics of Ten ADAPs With Highest Rates of Viral Suppression. The other infographic gives an analysis on the Ryan White Part B and ADAP partnership. Download the infographic, Ryan White Part B and ADAP Partnership to Bolster Health Outcomes.

Photo Source: NASTAD

Several advocates commented on the 2017 National ADAP Monitoring Project Annual Report, providing some important state perspectives. They include:

Ken Bargar, co-chair of the Florida HIV/AIDS Advocacy Network in Florida stated, "FHAAN has made access to our state's ADAP for Floridians a number one priority for many years. As Co Chair, I can tell you that we experience a great relationship with the Florida Department of Health, and we have provided many solutions for improving the program that they have implemented over the years. As a Medicaid non-expansion state, ADAP is crucial for people living with HIV in Florida. The increasing amount of clients receiving premium support for ACA plans has made this program robust and diverse in the ways they get access to HIV medication to our state’s most vulnerable clients. Recently, we were thrilled to see “pharmacy choice” finally became a reality for a section of the programs enrollees."

Eddie Hamilton, executive director of the ADAP Educational Initiative in Ohio, "In terms of transparency and the responsiveness to client’s concerns, Ohio's ADAP has come a long way since the last waiting list era. The ease of access to the program has drastically improved as there are now multiple routes of access (via case management, or direct application)."

Marcus J. Hopkins, an ADAP recipient and HIV/AIDS advocate in West Virginia, summarized, "West Virginia's ADAP is one of only twelve states in which 89% of enrolled clients in 2015 have achieved HIV Viral Loads ≤200. Our state had 1,139 clients in 2015, and only 3 Ryan White-specific clinics, meaning that many clients must travel 60 miles or more in order to reach one of these facilities. Our state is broken up into seven Ryan White regions, with 1 primary case manager contact per region. The small number of clinics serving 55 clinics (not including private Infectious Disease specialists) sometimes creates confusion, as clients living in different regions may have to coordinate between two different case workers. West Virginia's program also offers insurance continuation assistance, providing premium and co-pay assistance for clients enrolled in employer-based or ACA Insurance Marketplace coverage."

Matt Pagnotti, Director of Policy and Advocacy for AIDS Alabama, noted, "Since Alabama has failed to expand Medicaid under the ACA, the state's ADAP has operated as a vital safety net for thousands of people living with HIV in Alabama. Over three fourths of the clients served by Alabama's ADAP earn 133% FPL ($16,040 a year for a single adult) or less, most of whom find themselves in the "Medicaid coverage gap." In addition, roughly 16% of those served by ADAP in Alabama qualify for subsidized health insurance under the ACA marketplace. To assist these clients in overcoming financial barriers to access and create greater coverage completion, Alabama also operates an innovative Insurance Assistance Program that pays for premiums and co-payments."

The ADAP Advocacy Association commends NASTAD for its ongoing efforts to keep stakeholders informed, and engaged on the issues enumerated in this year's National ADAP Monitoring Project. Download a copy of the 2017 National ADAP Monitoring Project Annual Report.

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[1] Penner, Murray (2017, May 18); NASTAD Release: 2017 National ADAP Monitoring Project Annual Report; National Alliance of State & Territorial AIDS Directors.

[2] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 60. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.

[3] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 22. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.

[4] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 9. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.

[5] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 9. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[6] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 22. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[7] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 44. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[8] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 43. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.

What is All the Fuss Over Drug Importation?

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The rising cost of prescription drugs is on everyone's mind, and the issue is increasingly being scrutinized by the executive and legislative branches inside the Beltway. Even President Donald J. Trump has raised the issue over prescription drugs costs — though it typically ins't a signature Republican issue — and Senator Bernie Sanders (I-VT) has recently introduced legislation to allow drug importation. The debate over drug importation is a complex one, often muddled by talking points by both sides.

Here is how the American Association of Retired Persons (AARP) defines drug importation:

"Drug re-importation refers to the practice of importing back to the United States prescription drugs that were originally manufactured in the U.S. and exported for sale in another country. Most often, Americans re-import drugs for personal use by filling their prescriptions in Canadian or Mexican pharmacies, either in person, or through mail-order or Internet pharmacies."1

Proponents of the drug importation cite the need for consumers to access less expensive prescriptions drugs. According to a relatively recent national survey commissioned by Gallup, "27% of Americans name cost as top health problem."2

The U.S. Food & Drug Administration (FDA) found that one in ten Americans cannot afford their prescription drugs. That same study found approximately 1.6% of consumers have bought prescription drugs from another country.[3]

“There is no reason why drug importation should be a problem for the United States," said Eddie Hamilton of the ADAP Educational Initiative based in Ohio. "Generic Abacavir is already being imported into the U.S. from India  for domestic patients by ADAPs without issue.”

Photo Source: Huffington Post

The Sanders legislation is only latest attempt by Congress to allow drug importation. It has also gained support from some colleagues — Senators Cory Booker (D-NJ) and Bob Casey (D-PA) — in the Senate who had previously opposed drug importation legislation.

Though AARP hasn't yet endorsed the Sanders legislation (S.469), similar legislation did receive support from the organization. In 2009, AARP Senior Vice President David Sloane argued: “AARP is committed to helping our members and all older Americans have greater access to and reduced costs for the prescription drugs they need, including both through safe importation and other important measures such as closing the dreaded coverage gap in Medicare Part D known as the ‘doughnut hole.’"[3]

Senator Sanders isn't alone in his fight over drug importation, because Senator John McCain (R-AZ) has also introduced similar legislation. The McCain legislation (S.92) has bipartisan support, unlike the Sanders legislation.

Opponents have equally strong arguments against drug importation. Among them, concern over drug safety, including counterfeit or black market drugs. In 2014, a new resource for the HIV/AIDS community and their doctors was made available by the Community Access National Network (CANN) and Partnership for Safe Medicines. The resource, "Black Market HIV Drugs in the News, 2006-2013," sought to increase awareness of the severe health risks posed by counterfeit or black market medicines.[4]

Summarized Bill Arnold, CANN's President & CEO, who continues to have doubts about drug importation: "The importation or re-importation of medications from outlets other than those regulated by the FDA and other U.S. authorities is particularly dangerous for the HIV-positive patient. In the past, anti-retroviral drugs from this grey, or black, market system have turned up in many places. These drugs have turned out to be completely fake, improper potency, contaminated, and worse."

The Pharmaceutical Research and Manufacturers of America (PhRMA), who also opposes drug importation, has been very local about pitfalls over the potential lack of drug safety. The issue is characterized as "unsafe and lead to potentially dangerous outcomes for patients."[5]

PhRMA will host a policy briefing on the issue. The briefing, "Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients," will discuss the important role of the FDA in ensuring the safety of medicines from test tube to patient, the threat of counterfeit drugs to patient safety, the importance of the Drug Supply Chain Security Act and the implications of drug importation proposals. It is open to all interested stakeholders, but advance registration is required.[6]

It appears that Senator Sanders anticipated the pushback over drug safety, because his legislation requires foreign sellers to register with the FDA, as well as other safety measures. The add-ons should alleviate some concerns, but not all of them.

The ADAP Advocacy Association has also traditionally opposed drug importation, but it remains open to dialogue on the issue. Like most public policy issues, there is no easy answer or solutions. To that end, drug importation will be part of the conversation during our 10th Annual Conference later this year.

To register for the 10th Annual Conference, go to our website.
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[1] American Association of Retired Persons (AAPR), Prescription Drug Re-Importation Question and Answer Sheet, 2016; available online at http://assets.aarp.org/www.aarp.org_/articles/international/ReimportationQA.pdf.
[2] Gallup, Cost Edges Access as Most Urgent U.S. Health Problem, December 7, 2016; available online at http://www.gallup.com/poll/199169/cost-edges-access-urgent-health-problem.aspx?g_source=prescription+drug+costs&g_medium=search&g_campaign=tiles. 
[3] Renal & Urology News, Almost 1 in 10 Americans Can't Afford Medications Says CDC, February 4, 2015; available online at http://www.renalandurologynews.com/news/cdc-americans-can-not-afford-medications-eight-percent/article/395374/. 
[4] American Association of Retired Persons (AAPR), AARP Response to Senate Block on Prescription Drug Importation Legislation, December 11, 2009; available online at http://www.aarp.org/about-aarp/press-center/info-03-2010/aarp_response_tosenateblockonprescriptiondrugimportationlegislat.html.
[4] Partnership for Safe Medicines, Patient Advocates Warn of Dangers of Black Market HIV Medicines, May 21, 2014; available online at http://www.safemedicines.org/2014/05/patient-advocates-warn-of-dangers-of-black-market-hiv-medicines5-22-14.html.
[5] Pharmaceutical Research and Manufacturers of America (PhRMA), Fact Check Friday: The truth about drug importation and patient safety, February 24, 2017; available online at http://catalyst.phrma.org/fact-check-friday-the-truth-about-drug-importation-and-patient-safety.
[6] Pharmaceutical Research and Manufacturers of America (PhRMA), Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients, February 23, 2017.