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.  

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.

Pharmacists' Hands No Longer Tied by Pharmacy 'Gag Orders'

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

In healthcare the relationship between patients and their pharmacists is extremely important, similar to the one that exists between patients and their physicians. Thanks to bipartisan legislation that was signed into law late last year the patient-pharmacist relationship is even stronger. Gone are the ridiculous pharmacy “gag orders” that prohibited pharmacists from sharing with patients that they could save money by paying cash for prescription medications rather than using their health plan.

According to Kaiser Health News, both bills — one for Medicare and Medicare Advantage beneficiaries (S.2553) and another for commercial employer-based and individual policies (S.2554) — passed Congress with little dissent. The legislation was endorsed by the National Community Pharmacists Association (NCPA), American Medical Association, Alliance for Transparent and Affordable Prescriptions, ERISA Industry Committee, Pharmaceutical Care Management Association, and America’s Health Insurance Plans (Jaffe, 2018). Most patient advocacy groups also supported the effort to lift the gag orders.

Photo Source: NBC News | Saul Loeb / AFP - Getty Images

Senators Susan Collins (R-Maine), Claire McCaskill (D-Missouri), and Debbie Stabenow (D-Michigan) introduced the bipartisan legislation in the U.S. Senate. It passed 98-2. Representative Earl L. “Buddy” Carter — who is a pharmacist by trade — introduced the companion legislation in the U.S. House of Representatives.

"As a pharmacist for more than 30 years, I can say firsthand that I was prohibited many times from telling my patients that there was a cheaper option available to them because of a gag clause," Rep. Carter said in a statement upon introducing . "Pharmacists must be able to tell patients what is in their best interest and this legislation works to make that happen. Patients need and deserve the most affordable options" (Carter, 2018).

In recent years, states had already started to remove such restrictions. According to a detailed report by the National Conference of State Legislatures, between 2016 and 2018, at least 30 states enacted laws among at least 41 state legislatures that considered prohibiting “gag clauses” in contracts that restrict pharmacists (Cauchi, 2018). It has long been said that the states are the laboratories of democracy, and on this issue they proved to be right.

Photo Source: NCSL

It remains to be seen whether removing pharmacy gag orders will alleviate the high cost of prescription medications, but it is a good start. SpendingTracker.org estimates S. 2554 will save $88 million through 2028. There is no good, ethical reason why patients should be denied access to any information that might save them money. Pharmacists are an under-utilized community resource and the patient-pharmacist relationship is often under-appreciated but the new laws could change both.

References:

• Jaffe, Susan. (2018, October 10). No More Secrets: Congress Bans Pharmacist ‘Gag Orders’ On Drug Prices. Kaiser Health News. Retrieved online at https://khn.org/news/no-more-secrets-congress-bans-pharmacist-gag-orders-on-drug-prices/?utm_campaign=KHN%3A%20First%20Edition&utm_source=hs_email&utm_medium=email&utm_content=66566195&_hsenc=p2ANqtz--TqonAHxTESNQLYvXrCzV6Ta8RGY5mfzWX_3y0oo0TU3fXvMVOKEwAW2Y8tHO40ySyz20WKvEq8f0aKBzucUIfu36OJQ&_hsmi=66566195. 
• Carter, Earl L. (2018, September 7). Carter Introduces Measure to Prohibit "Gag Clause" Provisions. The Honorable Earl "Buddy" L. Carter. Retrieved online at https://buddycarter.house.gov/news/documentsingle.aspx?DocumentID=3529.
• Cauchi, Richard. (2018, December 1). Prohibiting PBM “Gag Clauses” that Restrict Pharmacists from Disclosing Price Options: Recent State Legislation 2016-2018. National Conference of State Legislatures. Retrieved online at http://www.ncsl.org/Portals/1/Documents/Health/Pharmacist_Gag_clauses-2018-14523.pdf. 

HIV Medication Adherence: Supporting Successful Treatment Strategies

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

Sticking firmly to an HIV medication regiment is probably the single most important thing people living with HIV/AIDS (hereafter referred to as patients) can do to help themselves remain healthy with an undetectable viral load. AIDSinfo explains why: "Adherence to an HIV regimen gives HIV medicines the chance to do their job: to prevent HIV from multiplying and destroying the immune system. HIV medicines help people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission."[1] Numerous strategies exist to promote better medication adherence to combat HIV/AIDS, with varying degrees of success.

Generally speaking about all health-related conditions, non-adherence results in additional healthcare costs, more hospital admissions, and approximately 125,000 deaths annually. Cost is often identified as the biggest barrier to better medication adherence.[2] Other barriers certainly exist.

Pharmacists on are the front lines in promoting medication adherence to their patients. According to the American Association of Colleges of Pharmacy (AACP), "Pharmacists practice in nearly all areas and specialties in healthcare – sometimes behind the scenes and not obvious to the public eye, but as the medication expert on the healthcare team, pharmacists are necessary in all facets of healthcare."[3]

For example, Walgreens uses local, patient-centric model with 3,000 ACPE-trained pharmacists (Accreditation Council for Pharmacy Education), as well as HIV-specialized pharmacies in high-incident areas nationwide. To improve medication adherence, pharmacists provide approved culturally competent adherence support through monthly reminders and follow ups.[4] The direct interaction with patients serves as an important tool to promote HIV medication adherence.

A project in the Netherlands trained 21 nurses to work with patients on self-management of their HIV medication regiment, and the project yielded some promising results. The Adherence-Improving Self-Management Strategy (AIMS) approach included the nurses sharing important information about adherence with patients; setting adherence goals; utilizing electronic medication bottle caps; and intensive follow-up with the patients during scheduled office visits.[5]

Read a summary on AIMS and its potential for improving HIV medication adherence.

A commitment contract between the patient and healthcare provider can improve HIV medication adherence and virologic suppression, according to a recent study. In some cases, cash incentives were offered during the clinical trial. The study, conducted at a publicly-funded HIV clinic in Atlanta, Georgia, demonstrated the most adherent patients entered into "a commitment contract that made the payment conditional on both attending the provider visit and meeting an ART adherence threshold." These patients were more adherent than patients who had received cash incentives, or the passive control arm of the study.[6]

Read a summary on Commitment Contracts.

One of the most effective strategies for patients, especially considering today's technology, is downloading a free calendar reminder Application. Reminder Apps can be downloaded from the Internet or from numerous other places, such as iTunes, Google Play, Microsoft Store, etc. In fact, Healthline published a useful review on this very topic last year in, "The Best HIV/AIDS Apps of 2016."[7]

Other strategies include daily/weekly pill boxes, pre-packaged medications, patient support groups, fixed dose once-daily anti-retrovirals, just to name a few. Since every patient is different it is important to consider treatment strategies that reflect the needs of the patient.

Whereas numerous barriers can make following an HIV medication regiment difficult — such as cost, complexity of treatment,  missed appointments — there exist a plethora of options designed to support successful treatment strategies. Like any chronic condition, medication adherence for people living with HIV/AIDS is important. It prevents patients from developing drug resistance and treatment failure, it prevents unnecessary hospital admissions, and it prevents higher healthcare costs.


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[1] AIDSinfo (2017, July 17); National Institutes of Health; HIV Medication Adherence; U.S. Department of Health & Human Services. Retrieved from https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/54/hiv-medication-adherence.
[2] CVS Health News (2017); Cost is the Biggest Barrier to Medication Adherence; CVS Health. Retrieved from https://cvshealth.com/thought-leadership/cvs-health-research-institute/cost-biggest-barrier-medication-adherence.
[3] PHARMCAS (2017); Role of a Pharmacist; American Association of Colleges of Pharmacy (AACP). Retrieved from http://www.pharmcas.org/preparing-to-apply/about-pharmacy/role-of-a-pharmacist/.
[4] Hou, J., Kirkham, H., Pietrandoni, G., & Delpino, A. (2016, August 23 – 26). Patient adherence to antiretroviral medications among patients using HIV- Specialized pharmacy and traditional pharmacy settings. Paper presented at the 2016 National Ryan White Conference on HIV Care and Treatment, Washington, DC.
[5] Jungwirth, Barbara (2017, May 17); A Nurse-Led Adherence Strategy Improves Life for People With HIV and Saves Money; TheBody.com. Retrieved from http://www.thebody.com/content/79916/a-nurse-led-adherence-strategy-improves-life-for-p.html?ic=700100&sp_rid=NjI5OTAwMTAxMTMS1&sp_mid=11051078.
[6] Alsan, Marcella, et al. (2017, July); AIDS; A commitment contract to achieve virologic suppression in poorly adherent patients with HIV/AIDS; International AIDS Society Journal. Retrieved from http://journals.lww.com/aidsonline/Citation/2017/07310/A_commitment_contract_to_achieve_virologic.15.aspx.
[7] Carey, Elea, and Jared Fields (2016, June 13); The Best HIV/AIDS Apps of 2016; Healthline. Retrieved from http://www.healthline.com/health/hiv-aids/top-iphone-android-apps#1.