Harvard Pilgrim Health Care Offered Discriminatory Plans to People Living with HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Discrimination is nothing new for people living with HIV/AIDS (PLWHAs), as it impacts multiple facets of their daily lives. Aside from HIV-related discrimination in employment, housing, healthcare, and criminal justice, an often-overlooked area is insurance. Discriminatory plan design refers to the barriers health insurance companies impose on PLWHAs thereby limiting access to care and treatment for years, advocacy groups have battled insurers with public scrutiny and, in some cases, litigation (Andrews, 2016.) Despite some coverage improvements, complaints and lawsuits continue as insurers maintain practices in non-compliance with federal law. 

Photo Source: AIDS Foundation of Chicago

One recent large plan instance of discriminatory coverage involved Harvard Pilgrim Health Care (HPHC). In November of 2024, the HIV+Hepatitis Policy Institute filed discrimination complaints against HPHC because their Core 4-Tier and Core 5-Tier plans in Maine, New Hampshire, and Rhode Island contained inadequate coverage of HIV antiretrovirals in violation of the ACA. In solidarity of the cause, several other groups sent a letter to the insurer. A few of the groups included were the Federal AIDS Policy Partnership (FAPP), HealthHIV, NASTAD, and AIDS Alabama (HIV+HEP, 2024).

The U.S. Department of Health and Human Services (HHS) guidelines recommend four preferred treatment regimens as initial HIV antiretroviral therapy: Biktarvy, Dovato, Symtuza, or a combination of Tivicay with either Truvada or Descovy (“Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV,” n.d.). The plans only covered Dovato or Tivicay + Truvada. Biktarvy is a single-pill regiment prescribed to over 49% of PLWH and should be covered (HIV+HEP, 2024). Dovato was covered but is not appropriate for PLWH with high viral loads or HIV that is resistant to lamivudine or dolutegravir. The plans excluded Symtuza, even though it is the only recommended treatment for PLWH who have taken long-acting injectable PrEP (cabotegravir) and have possible HIV resistance to Integrase strand transfer inhibitors (INSTI) (HIV+HEP, 2024). There are other clinical situations where HHS guidelines recommend Delstrigo, Odefsey, Triumeq, and a combination of Prezcobix and Epzicom as initial regimen alternative therapies. The plans covered only Odefsy and Triumeq (HIV+HEP, 2024).

When patients lose access to covered medications, they not only experience lapses in treatment but sometimes must change to treatments that are not the best for them. Sometimes, even alternative therapies still result in a financial burden or non-adherence due to treatment. If a patient is moved from a single-pill regimen to a multi-pill treatment, they are likely to have issues staying consistent with their treatment plan (HIV+HEP, 2024). Lack of coverage on one plan may also force a patient to choose a different one that may cover their needed medication but has adverse financial effects.

Photo Source: HIV + HEP Policy Institute

As a result of advocacy bringing public awareness directed at state policy leadership and insurance carriers, HPHC reversed its problematic coverage decisions and updated the Maine, New Hampshire, and Rhode Island formularies at the end of December. For 2025, they now cover eight complete initial HIV treatment regimens: Biktarvy, Dovato, Symtuza, Tivicay (in combination with Truvada or Descovy), Delstrigo, Odefsey, Triumeq, and Prezcobix (in combination with abacavir and lamivudine) (HPHC, 2025). While this is progress, the medications are located on the highest drug tiers of the formularies. This may render the formularies clinically effective, but they are still cost-prohibitive. Drugs on the highest formularies have the highest cost-sharing for patients, requiring them to pay significant percentages of the drug's prices as co-insurance. A high financial burden is still a barrier to access and effective care. 

As Tim Horn, Director of Medication Access with NASTAD, points out, “Relegating virtually all branded antiretrovirals to the highest cost-sharing tiers has been associated with co-insurance that typically exceeds 25% of the retail cost of the prescribed antiretroviral drug product(s), which can be considerable costs, certainly for plan beneficiaries but also for safety net programs like state ADAPs.” Director Horn also adds, “ADAP-funded insurance programs providing premium and cost-sharing support for people living with HIV are likely important factors in these carriers' decisions to ultimately engage in discriminatory formulary design practices. Of course, it is vitally important that ADAPs are able to provide premium and cost-sharing support for their clients and, likely, a significant proportion of otherwise uninsured people living with HIV in these states.”

Insurance companies do not want ADAPs to utilize their plans because they are a built-in permanent population of covered lives requiring expensive medication. Director Horn further explains, “Carriers, particularly those operating in states where few other carriers or Marketplace plans, likely consider ADAPs making their plans affordable for people living with HIV as a risk to their bottom lines. The result, as we saw with the initial Harvard Pilgrim Health decision to remove a huge swath of important antiretroviral drugs from its core formularies in three states, can be profoundly cynical and discriminatory practices that can have serious repercussions for both people living with HIV and the vitally important, yet fiscally constrained, HIV programs, such as state ADAPs.”

According to Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, more vigorous enforcement would be a solution to discriminatory plan design. For example, in Texas, the Affordable Care Act guidelines are not enforced by the state insurance regulator but are enforced by the federal government. Moreover, the federal government constructs templates delineating ACA appropriate coverage guidelines for insurance plans to follow. Schmid explains that the templates in use are outdated, thus not reflecting current best practices. Hence, the federal government is not effectively engaging in enforcement. 

Unfortunately, advocacy groups and public outcry are how most insurance companies’ discriminatory plan malfeasance comes to light. Currently, many other grievances are being elevated and watched. Two, in particular, involve Medica and Community Health Choice Texas. HIV + HEP Policy Institute filed complaints against Medica in Minnesota and Iowa for inadequate recommended coverage in addition to placing all HIV antiretrovirals on their highest tiers. Their filing in Texas against Community Health Choice was also regarding inadequate HIV drug coverage regarding treatment guidelines (Burke, 2024).

The vigilance of advocacy groups, patients, and other entities is the only robust tool against discriminatory plan design. Until more effective federal and state enforcement occurs, there will not be any consistent ethical and legal behavior in the industry. The law, regulations, guidance, and implementation all must be aligned. As Schmid states, “Insurers will try to get away with as much as they can until they are caught.”

Patients living with HIV experiencing similar health plan discriminatory design are encouraged to alert the HIV + HEP Policy Institute at https://hivhep.org/contact/.

[1] Andrews, M. (2016, October 18). 7 Insurers Alleged To Use Skimpy Drug Coverage To Discourage HIV Patients. Retrieved from https://kffhealthnews.org/news/7-insurers-alleged-to-use-skimpy-drug-coverage-to-discourage-hiv-patients/

[2] Burke, J. (2024, December 17). Press Release. Retrieved fromhttps://hivhep.org/wp-content/uploads/2024/12/hiv-discrimination-complaints-maine-harvard-pilgrim-12.17.24.pdf

[3] Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. (n.d.). In Centers for Disease Control and Prevention, U.S. Food and Drug Administration, Health Resource and Services Administration, & National Institutes of Health, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/tables-adult-adolescent-arv.pdf

[4] Harvard Pilgrim Health Care. (2025, January 2). Press Release. Retrieved from https://www.harvardpilgrim.org/public/news-detail?nt=HPH_News_C&nid=1471978029629

[5] HIV + HEP Policy Institute. (2024, November 8). Substandard & Discriminatory HIV Medication Coverage & Plan Design by Harvard Pilgrim Health Care. Retrieved from https://hivhep.org/wp-content/uploads/2024/11/maine-harvard-pilgrim-HIV-complaint-11.8.24.pdf

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. 

Biden Sides with Insurers, Shifting More Costs to Patients

By: Ranier Simons, ADAP Blog Guest Contributor

The high cost of healthcare is the product of a complex, fragmented financing system. The machinations of multiple public and private payors coupled with the advent of middlemen, such as pharmacy benefit managers, in the healthcare expenditure landscape often hinder the development of common sense solutions. This is especially true in the present discourse surrounding 340B Drug Pricing Program, Prescription Drug Affordability Boards (PDABs), and Alternative Funding Programs, which are all intertwined around 'controlling' prescription drug costs. At the center of the medical, fiscal maelstrom is the patient. Rising medical debt has a crushing impact on many aspects of patients’ lives and healthcare outcomes. Potential solutions come and go. Unfortunately, one remedy to alleviate patient costs recently failed. The Biden Administration fell short of instituting promised regulations surrounding patient protections against insurers abusing copay assistance programs.[1]

Photo Source: Lifepoint Health

The 2026 Notice of Benefit and Payment Parameters (NBPP) proposed rule was posted to the Federal Register on October 10th.[1] This rule addresses many things, including the operations of insurance plans. The executive summary states explicitly, “Our goal with these proposed requirements is providing quality, affordable coverage to consumers while minimizing administrative burden and ensuring program integrity. The changes proposed in this rule are also intended to help advance health equity, mitigate health disparities, and alleviate discrimination.”[1] However, the proposed rule lacks promised provisions that would have closed essential health benefits loopholes and shielded patients from adverse cost-sharing activities by insurers. In the NBPP, insurers won and patients lost.

This is a fight that many advocates felt had already been won, thanks to the combined efforts of the HIV+Hepatitis Policy Institute, Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition. In September of 2023, a federal court struck down a previous federal rule issued under the Trump Administration that allowed insurance companies to use copay accumulators and maximizers, which allowed them to take advantage of manufacturer copay assistance programs to the detriment of patients.[2] This ruling meant that insurers had to follow previous 2020 federal guidelines that prohibited the usage of copay accumulator practices except with regard to brand name drugs that have generic equivalents if allowed by state law.[3]

The court remanded authority back to the U.S. Department of Health & Human Services (HHS), meaning the federal government needed to issue new regulations. The government previously in November 2023 stated in a brief that it would issue new rules directly addressing the prohibition of copay accumulator practices.[4] Yet, it has not, and the 2026 NBPP does not do that. As of January 2024, 19 states have passed legislation that bans or restricts accumulators in individual or small-group health plans.[5] That leaves patients in many states unprotected without federal regulation that explicitly bans copay accumulator practices. Without protection, patients are still victim to insurers using copay accumulators, maximizers, and even alternative funding programs.

The 2026 NBPP also does not include a provision to close an essential health benefits loophole insurers, and PBMs are taking advantage of it. Essential health benefits (EHB) are categories of services the Affordable Care Act (ACA) states insurance plans must cover.[6] One of those categories is prescription drugs. The ACA provides cost-sharing limits on EHBs. What is happening is that PBMs are investigating which drugs have high-cost thresholds or those for which manufacturer copay assistance programs are available. They subsequently identify those drugs as ‘non-essential health benefit’ drugs, removing their shield of protection. That designation enables them to siphon all of the manufacturer copay assistance funds to themselves without applying it to patients' deductibles and other cost-sharing. A 2025 NBPP rule closed this loophole for individual and small group markets but is still open for large group and self-funded plans. The 2026 NBPP does not bring the federal government’s promise to close the loophole to fruition.

Photo Source: Chronic Disease Coalition

Copay accumulators, maximizers, and alternative funding programs increase patients’ financial burden while lowering costs and increasing profits for insurance plan sponsors and other vendors. Copay accumulators accept manufacturer copay assistance funds up to the limits of patients’ insurance deductibles while not counting it towards patients’ out-of-pocket contributions towards their deductible.[5] Adam J. Fein, Ph.D. with the Drug Channels Institute, summarized, "Benefit designs have been shifting drug costs to patients, some of whom are now responsible for a much greater share of their prescription costs. These out-of-pocket expenses can be quite high, especially for more expensive specialty drugs when patients face coinsurance amounts and payment in the deductible coverage phase."[5] Thus, patients still have to meet their out-of-pocket contributions even after they have already been met by the copay assistance program. The insurance plan is effectively being paid twice, known as ‘double dipping.’

Copay maximizers are more nefarious because they drain a disproportionate share of manufacturer assistance funding.[5] Here, the plans set a patient’s out-of-pocket obligation to match the maximum value of support the copay assistance program provides. Thus, even if a deductible is $5,000, a patient’s out-of-pocket obligation could be set to $20,000 if that was the maximum use case of a particular copay assistance program. Patients incur very low out-of-pocket costs, but funding that could be stretched to help more patients is drained into industry coffers.

Alternative funding programs are the newest development in violating patient protections. Here, plans eliminate coverage entirely for specialty or costly drugs, thus leaving patients with the plans effectively uninsured.[5] Then, the patients are made to apply for patient assistance programs, which pay the entire list price for the drug. Patients incur minimal costs. However, plan sponsors and other vendors are paid the entire list cost value, which reduces their plan expenses but is a significant and improper financial depletion of assistance funds.[5] Additionally, there are delays involved in patients applying for these programs, and some are denied. Delays and denials are unnecessary barriers to patient access to medication that should be essential health benefits.

Photo Source: First Federal Credit Control

Since the EHB loophole remains open for large group and self-funded plans, masses of patients are left unprotected. It is not enough for the federal government to acknowledge a problem. Effective remedy requires acknowledgment of a problem, specific delineation of a solution, followed by enforcement of the solution. It is likely this loophole will only exacerbate the growing problem with medical debt.

Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, encapsulates the situation perfectly, stating, “Every day these rules are delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients who are struggling to afford their drugs. Coming from an administration that prides itself on supporting patients and lowering their prescription drug costs, this is a huge disappointment. While they have gone on record that they will issue these rules, the clock is ticking, and there isn’t much time left.”[7]

[1] National Archives and Records Administration. (2024, October 10). Proposed Rule: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program. Retrieved from https://www.federalregister.gov/documents/2024/10/10/2024-23103/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2026-and

[2] United States District Court. (2023, September 29). Memorandum Opinion. Retrieved from https://hivhep.org/wp-content/uploads/2023/09/HIV-Hepatitis-Policy-Institute-v.-HHS-DDC-opinion.pdf

[3] HIV+Hepatitis Policy Institute. (2023, October 2). Court Strikes Down HHS Rule that Allowed Insurers to Not Count Copay Assistance. Retrieved from https://hivhep.org/wp-content/uploads/2023/10/copay-accumulator-court-decision-press-release-10.2.23.pdf

[4] United States District Court. (2023, November 27). Defendant's Conditional Motion to Clarify Scope of Court's Order. Retrieved from https://hivhep.org/wp-content/uploads/2023/11/govt-clarification-request.pdf

[5] Fein, A. (2024, February 14). Copay Accumulator and Maximizer Update: Adoption Expands as Legal Barriers Grow. Retrieved from https://www.drugchannels.net/2024/02/copay-accumulator-and-maximizer-update.html

[6] HealthCare.Gov. (2024). Essential Health Benefits. Retrieved from https://www.healthcare.gov/glossary/essential-health-benefits/#:~:text=A%20set%20of%2010%20categories,offers%20when%20you%20compare%20plans

[7] HIV+Hepatitis Policy Institute. (2024, October 4). Biden-Harris Administration Sides with Insurers & Fails to Take Steps to Lower Patient Costs for Prescription Drugs. Retrieved from https://hivhep.org/press-releases/biden-harris-administration-sides-with-insurers-fails-to-take-steps-to-lower-patient-costs-for-prescription-drugs/

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.   

Provider ‘Smash and Grab’ Tactics Fueling Medical Debt, Hurting Patients

By: Ranier Simons, ADAP Blog Guest Contributor

In the United States, healthcare is one universal expense incurred by everyone, regardless of their station in life. Approximately 100 million people in this country, including 41% of adults, have some sort of medical debt.[1] Some people can manage it, but many struggle. As a result of medical debt, people have had to cut spending on food and necessities, deplete savings, delay purchasing a home, work multiple jobs, or even declare bankruptcy.[1]

Photo Source: iStock (purchased)

Most of the medical debt is actually hospital debt, and that debt is owed to large hospitals, not small private practices. In the United States, there are two different types of hospitals: for-profit and nonprofit. There are 5,139 community hospitals, with 1,228 being for-profit, 951 being state and local government-run hospitals, and 2,960 being non-governmental nonprofit health facilities.[2] For-profit hospitals are business-oriented and owned by investors and shareholders; thus, they are focused on making money for their stakeholders. Nonprofit hospitals are not beholden to any shareholders or investors. In theory, their profits are to be reinvested into the hospitals for their operations. Additionally, nonprofit hospitals are tax-exempt and required to provide more community health services and serve patients regardless of whether they can afford care. Unfortunately, some nonprofit hospitals are the worst offenders when it comes to saddling patients with debt.

Nonprofit hospitals do not pay any federal and state income, property, or sales taxes and receive other tax breaks.[2] In 2020, the nation’s nonprofit hospitals received an estimated $28 billion in tax benefits, accounting for 44% of their net income.[3] In return for the tax benefits, the federal government requires nonprofit hospitals to provide community benefits such as charity care. Charity care is providing services to low-income people for free or at significantly reduced rates.[3] The Affordable Care Act (ACA) also mandates that they must maintain a transparent and available financial assistance program and refrain from taking “extraordinary collection actions” against patients eligible for charity care.[4] The reality of some of the largest nonprofit hospitals is a travesty of the concept of charity care.

Photo Source: National Nurses United

Some nonprofit hospitals aggressively pursue patients over their bills. They garnish paychecks and sell patient accounts to collection agencies (debt buyers) that harass and intimidate. Lawsuits are filed against patients for outstanding balances. Some of them are filed against people who qualify for charity care. These lawsuits attach legal fees and late payment interest, multiplying the original outstanding debt amounts. Moreover, some hospitals pursue family members for a patient’s medical debts and even place property liens on patients’ homes. Many do not find out about property liens until a relative has passed. Property liens lower the value of homes and adversely affect the transference of intergenerational wealth.

Federal tax law mandates that nonprofit hospitals spend some of their revenues as community benefit and defines the kind of spending that qualifies but does not stipulate the amount. Charity care is just one of the defined categories of spend. In 2020, nonprofit hospitals had approximately $28 billion in tax exemptions but provided only $16 billion in free or discounted services through charity care.[5] 

U.S. Senator Bernie Sanders, chair of the Senate Committee on Health, Education, Labor & Pensions (HELP), filed a congressional report on nonprofit hospitals and their tax exemptions. The committee examined 16 of the largest nonprofit health systems in the U.S., finding that they spent less than 60% of the estimated value of their tax breaks on charity care.[6] The 16 hospital chains examined took in more than 3$ billion in annual revenue. Twelve of the 16 chains dedicated less than two percent of their total revenue to charity care, with 6 of those 12 having less than 1% of their total revenue dedicated to charity care.[3] Between 2012 and 2019, nonprofit hospitals increased their average operating profit by more than 36% and almost doubled their cash reserves. In the same timeframe, charity care spending dropped from only $6.7 million to $6.4 million.[3] Ironically, in 2021, of the 16 nonprofit hospital chains in the report, the average CEO compensation was $8 million, with a collective total of more than $140 million.[3]

Photo Source: WRAL

Editor's Note: ADAP Advocacy recently called into question 340B Drug Discount Program practices with an examination focused on growing 340B revenues, increasing executive compensation, declining charity care, and the exploding medical debt.

Sen. Sanders feels that Congress should specifically define the level of charity care and financial assistance required of nonprofit hospitals. One suggestion is that tax breaks be limited to the amount of charity care provided. Additionally, Sanders feels that hospital financial assistance programs should have defined standards. For example, some of the hospitals do not transparently explain, advertise, or actively facilitate entering qualified patients into the programs. Instead, some hospital systems, such as Atrium in North Carolina, steer patients towards loans to pay their outstanding bills that sometimes have interest rates as high as 13%.[7]

Hospital groups pushed back against the analyses by Sen. Sanders, but they also tend to oppose any accountability or transparency reforms.. The American Hospital Association states that nonprofit hospitals' community benefit is comprehensive and encompasses more than just charity care. It says that community benefit includes research, medical innovation, absorbing underpayments from Medicaid, health education, and housing assistance.[6,8] That sentiment is misleading and flawed. For example, a good deal of research is funded by taxpayers’ dollars.

Jen Laws, President & CEO of the Community Access National Network (CANN), isn't buying the AHA's argument. According to Laws, financial assistance and community benefit are different line items on the Internal Revenue Service's Form 990 for a reason. In fact, CANN has been quite vocal on the need for reforms to programs designed to help indigent patients, yet are falling short of that intended goal.

According to Laws, community assumption is a "good faith" definition, but loopholes surrounding hospital-related nonprofit status tax rules inevitably can lead to bad faith in this space, or even abuse. He believes the overwhelming body of evidence surrounding the decline in hospital charity care is in direct opposition of the IRS' intention, namely providing a benefit to needy persons, families, and communities.

Laws said, "For example, our government, namely the IRS, hasn't updated 'community benefit' rules in decades and many no longer apply, like having an open Emergency Room. This gets to the core of CANN's position - honesty is not part of that muddy language. And we need to be frank about that lack of honesty."

It is crucial that community benefit standards are revamped with a focus on charity care that directly benefits those in need. In some states, the difference between the amount of funds spent on charity care and the total tax exemptions the nonprofit hospitals receive is greater than the recorded debts listed on patients' credit reports.[3] Change must come so that needy patients' lives are no longer ruined by being sued by hospitals for outstanding balances as low as $500 or less that they can’t afford to pay.

[1] Levey,N. (2022, June 16). 100 Million people in America are saddled with health care debt. Retrieved from https://kffhealthnews.org/news/article/diagnosis-debt-investigation-100-million-americans-hidden-medical-debt/

[2] Modi, J. (2023, March 21). Nonprofit vs. for-profit hospitals: what’s the difference? Retrieved from https://www.buzzrx.com/blog/nonprofit-vs-for-profit-hospitals-whats-the-difference

[3] United States Senate Health, Education, Labor, and Pensions Committee. (2023, October 10). Mahority Staff Report: Major Nonprofit Hospitals Take Advantage of Tax Breaks and Prioritize CEO Pay Over Helping Patients Afford Medical Care. Retrieved from https://www.sanders.senate.gov/wp-content/uploads/Executive-Charity-HELP-Committee-Majority-Staff-Report-Final.pdf

[4] 26 U.S.C 501(r)(4), (6); Internal Revenue Serv, Billing and Collections – Section 501(r)(6) (Jul. 13, 2023), https://www.irs.gov/charities-non-profits/billing-and-collections-section-501r6. 

[5] Miller, A., Hawryluk,M. (2023, July 11). As Nonprofit hospitals reap big tax breaks, states scrutinize their required charity spending. Retrieved from https://kffhealthnews.org/news/article/nonprofit-hospitals-tax-breaks-community-benefit/

[6] Wilkerson,J. (2023, October 10). Bernie Sanders bashes nonprofit hospitals over their tax breaks. Retrieved from https://www.statnews.com/2023/10/10/bernie-sanders-nonprofit-hospitals/

[7] Levey,N. (2023, August 16). North Carolina hospitals have sued thousands of their patients, a new report finds. Retrieved from https://kffhealthnews.org/news/article/north-carolina-hospitals-patient-debt-lawsuits/

[8] American Hospital Association. (2023, October). Tax-exempt hospitals provided nearly $130 billion in total benefits to their communities. Retrieved from https://www.aha.org/system/files/media/file/2023/10/Results-from-2020-Tax-Exempt-Hospitals-Schedule-H-Community-Benefit-Reports.pdf

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.  

Affordable Care Act Marketplace Plans & Drug Benefit Design

By: Ranier Simons, ADAP Blog Guest Contributor

Healthcare insurance policy and finance are not abstract entities relegated to the arenas of political debate and Wall Street discourse. The convoluted machinations of how money flows in healthcare insurance finance affect the bank account of anyone who has ever been prescribed a prescription drug. People living with HIV are very aware of the importance of understanding how insurance operates regarding paying for expensive antiretroviral medications that cost thousands of dollars per month. 

Photo Source: Sciworthy

When choosing insurance plans, one of the most important aspects people living with HIV/AIDS (PLWHA) consider is how or if a particular plan covers their anti-retroviral (ARV) therapy. AIDS Drug Assistance Programs (ADAP) also pay close attention to drug coverage and drug pricing, given that they help provide medications to those who are uninsured as well as those who are underinsured. The Affordable Care Act (ACA) has enabled many PLWHA to access lifesaving medicines. However, the drug benefit design of many qualified health plans (QHP) participating in the ACA Marketplaces can hinder expeditious access to efficacious drugs.

A recent study examined how insurance benefit design affects antiretroviral access. The study focused on the changes in insurance coverage of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Triumeq (dolutegravir/abacavir/lamivudine). These two drugs are first-line single-tablet regimens that have proven to be very effective. The U.S. Food & Drug Administration (FDA) approved Triumeq in 2014 and Biktarvy in 2018. Current treatment guidelines suggest that PLWHA start ART as soon as possible upon diagnosis, same day if possible. However, the study showed that access to novel treatments, such as Triumeq and Biktarvy, is slowed by delayed QHP coverage and benefit design.[1]

Photo Source: Rohan Khazanchi, MD, MPH | Twitter

The study assessed individual and small-group QHPs’ responses to the two new regimens. For the years 2018-2020, researchers examined coverage, cost sharing, specialty tiering, prior authorization (PA), and out-of-pocket (OOP) costs for Triumeq and Biktarvy nationally under QHP’s. Coverage refers to if a plan does or does not offer a drug in its formulary. Cost sharing refers to copays and coinsurance for drugs. A copay is a set fee patients pay for a prescription, whereas coinsurance is a percentage of a drug’s wholesale cost. Specialty tiering is the designation insurance drug formularies give to medications based on their costs. The higher the tier, the more of the costs are passed onto the consumer. More expensive drugs, such as ART, are in the higher tiers. Prior authorization is the bureaucratic process requiring healthcare providers to get pre-approval from a health plan before a drug is prescribed for the patient to qualify for payment coverage.

For 2018, 2019, and 2020, respectively, the study identified 19,533, 17,007, and 21,547 QHPs.[1] Overall, in 2018, 93% of the QHPs covered Triumeq, but only 60% covered Biktarvy. Triumeq coverage increased to 97% in 2019 and decreased to 91% in 2020. Biktarvy coverage decreased to 59% in 2019 but sharply increased to 86% in 2020. Concerning coinsurance, over the entire study period, a higher percentage of QHP’s required coinsurance for Biktarvy than Triumeq. The study also explicitly assessed coverage comparisons in EHE (Ending the HIV Epidemic Initiative) Phase I priority jurisdictions. Overall, across all three years studied, in both EHE and non-EHE jurisdictions, more QHPs covered Triumeq than Biktarvy. Interestingly, Biktarvy QHP coverage in 2020 was higher in EHE jurisdictions (90%) compared to non-EHE jurisdictions (85%). Biktarvy coverage in EHE jurisdictions increased from 74% in 2018 to 90% in 2020 due to increased coverage with coinsurance and copays. The study also found differences in prior authorization requirements. The prevalence of PA requirements for Triumeq was very low (2%, 2%, and 1% for 2018, 2019, and 2020, respectively).[1] PA prevalence was higher for Biktarvy, with 5% in 2018 and 8% in 2019. In 2020 all QHP had eliminated Biktarvy PAs except for 18 plans in Washington State.

Photo Source: HIVinfo

A multi-center, phase 3, double-blind, randomized control clinical trial of treatment naïve PLWHA showed that Biktarvy had the efficacy of viral suppression equal to Triumeq.[2,3] Additionally, it showed that Biktarvy had no evidence of treatment-emergent resistance and was better tolerated gastrointestinal due to its formulation and smaller pill size. Moreover, Biktarvy does not contain abacavir and thus does not require HLA-B*5701 testing making it a good candidate for same-day ARV initiation.[1] 

Evidence-based data showed Biktarvy to be a better candidate for first-line drug treatment for many than Triumeq. Yet, as stated previously, QHPs lagged in coverage of Biktarvy compared to Triumeq, even in EHE priority-1 jurisdictions. There were higher OOP costs given that more QHP’s required coinsurance for Biktarvy, and PA requirements were also initially more frequent for Biktarvy.

The critical takeaway from the study is that QHPs can slow the adoption of new HIV single-pill regimens by non-coverage decisions and other hurdles that limit access.[1] This does not stop at single-pill regimens. Ongoing HIV research continues to produce novel and innovative treatments such as Cabenuva and Sunlenca. Insurance companies base their coverage decisions mainly on the costs of the medications. Strident efforts are needed to create regulations to lower drug pricing. Additionally, cost-sharing measures need to evolve, such as basing patient coinsurance on post-PBM discounted drug prices instead of pre-discounted prices.[1] 

Increasing the pricing of novel and effective medication challenges ADAP’s ability to continue to help people. Additionally, prohibitive OOP costs for patients discourage medication adherence and treatment initiation. Many structural barriers to HIV treatment equality exist. Runaway pharmaceutical pricing and insurance drug coverage that is not scientifically evidence-based should not be amidst those barriers.

[1] Khazanchi, R., Powers, S., Killelea, A. et al. Access to a novel first-line single-tablet HIV antiretroviral regimen in Affordable Care Act Marketplace plans, 2018–2020. J of Pharm Policy and Pract 16, 57 (2023). https://doi.org/10.1186/s40545-023-00559-8

[2] Acosta RK, Willkom M, Martin R, et al. Resistance analysis of Bictegravir–Emtricitabine–Tenofovir Alafenamide in HIV-1 treatment-naive patients through 48 weeks. Antimicrob Agents Chemother. 2019;63(5):e02533-18. https://doi.org/10.1128/AAC.02533-18

[3] Coffey S, Bacchetti P, Sachdev D, et al. RAPID antiretroviral therapy: high virologic suppression rates with immediate antiretroviral therapy initiation in a vulnerable urban clinic population. AIDS. 2019;33(5):825–32. https://doi.org/10.1097/QAD.0000000000002124

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.  

Culture War Against ACA Scores Win

By: Ranier Simons, ADAP Blog Guest Contributor

March 23, 2023, was the 13th anniversary of the signing of the Affordable Care Act (ACA). The landmark legislation forever changed the landscape for healthcare insurance and healthcare access in the United States. About 35 million people presently have ACA-related healthcare coverage, with 21 million of those enrolled in Medicaid expansion coverage.[1] The law enabled many to obtain robust healthcare coverage who were previously uninsured or underinsured. Most importantly, while not perfect, the ACA is an effective tool to support equity in healthcare coverage and treatment. Through the ACA, participants receive comprehensive and affordable care regardless of their income or lack of.

Unfortunately, from its inception to the present day, there have been political battles over the ACA that are ideological instead of evidence-based. Politicians, judges, and media personalities continually attempt to dismantle the ACA without having the plan to replace it. Opponents of the law have found an ally in Judge Reed O’Connor, a federal judge in Texas. In 2018, Judge O’Connor ruled that the entire ACA was unconstitutional. The Supreme Court eventually defeated the ruling. Judge O’Connor has previously made rulings against the ACA’s non-discrimination provisions, contraceptive coverage requirement, and regulation of insurance provider fees in states.[2]

Photo Source: Law.com

Judge O’Connor’s latest challenge to the ACA is in Braidwood Management Inc. v. Becerra. In this case, six individuals and Christian-owned businesses claim that private health insurance coverage requirements are unconstitutional. Additionally, they argue that being required to provide coverage for PrEP under their insurance plans violates their religious beliefs and thus violates the Religious Freedom Restoration Act (RFRA).[3]

The ACA requires insurers to cover certain preventative care services without any cost-sharing by the insured. Those services will be provided for free when obtained through a provider in an insurance plan’s network. The ACA uses guidance from the United States Preventative Task Force (USPSTF) to determine the aforementioned services. The USPSTF was created in 1984 by the U.S. Public Health Service Act to improve public health through evidence-based recommendations to prevent disease and increase life expectancy.[4] Sixteen national experts on preventative medicine and primary care comprise the USPSTF. They make their recommendations based on scientific evidence with no conflicts of interest or political influence.

Photo Source: Axios

In September 2022, Judge O’Connor ruled that the USPSTF violates the Appointments Clause because the members are not appointed by the President and subsequently confirmed by the Senate; nor are their recommendations reviewed by Constitutionally specified officials. Thus, he decided that the Braidwood Management plaintiffs should not be required to pay for conventional medical insurance plans that mandate coverage of preventative services recommended by the USPSTF because the entity and its recommendations are unconstitutional. Judge O’Connor further ruled that the PrEP coverage mandate violated Braidwood’s religious freedom rights under the RFRA. Braidwood argued that paying for coverage that included provisions for PrEP made them implicit in supporting homosexuality, drug use, and sex between a man and a woman outside of marriage. At the time of the initial ruling, legal remedies had not been specified, and both sides were instructed to present briefs relating to the scope of relief. Moreover, the initial focus was explicitly on Braidwood being required to pay for plans that provided PrEP without cost sharing and the non-religious plantiffs not being required to pay for preventative services such as contraception and std testing.

March 30, 2022, Judge O’Connor ruled on the case's legal remedy. He invalidated the ACA's HIV treatment mandate of providing PrEP, stating it violated Christian employers' rights under the RFRA. Thus, the government could not take any legal action requiring the Braidwood parties and religious objectors to pay for PrEP. He went a step further, stating that any recommendations for preventative services made by the USPSTF on or after March 30, 2010, are unlawful. Effectively, this is a national block meaning insurance plans no longer must cover many preventative services for free. These services include biennial mammography screening for women aged 50-74, cervical cancer screening in women aged 21-65, colorectal cancer screening in adults aged 45-49, and PrEP. The complete list of these services is here. 

Without coverage for PrEP, it is estimated that over 2000 preventable HIV infections will occur within a year.[7] For every 10% decrease in PrEP coverage, there would be an additional 1,140 HIV infections among MSM the following year. Generic PrEP costs $30 per month, and brand-name products that don’t have generic versions can cost over $20K annually. Additionally, there are lab work and provider visits associated with the administration of PrEP. Those expenses are around two thousand dollars a year. Blocking the HIV treatment mandate would result in cost-sharing or complete denial of coverage resulting in out-of-pocket costs that those needing help cannot afford.

Photo Source: NPR

Blocking the coverage mandate for other preventative services would also have dire consequences. Lack of certain screenings means that many conditions, including cancers, will go undiscovered until late stages. This would result in many preventable diseases, decreased healthcare outcomes, including death, and increased medical costs. Such a future is in opposition to the Institute for Healthcare Improvement’s “Triple Aim”: improving the individual experience of care, improving the health of populations, and reducing the per capita costs of care for populations.[8]

Judge O’Connor’s ruling is not the final law. There will be appeals, and it could reach the Supreme Court. Presently in 2023, no plans are affected since the current coverages are in place via the contracts policyholders have with their insurance companies. Additionally, it is possible a hold will be placed on the order as it makes its way through the courts. The American College of Obstetricians and Gynecologists, in a statement, said: "Allowing personal or political bias to interfere with the practice of medicine will cause harm to our patients."[6] Unfortunately, recent policy decisions in Tennessee, New York, and now Texas seem to be setting up the harm the American College of Obstetricians and Gynecologists warns against.

[1] U.S. Department of Health and Human Services. (2022, April 29). New Reports Show Record 35 Million People Enrolled in Coverage Related to the Affordable Care Act, with Historic 21 Million People Enrolled in Medicaid Expansion Coverage. Retrieved from https://www.hhs.gov/about/news/2022/04/29/new-reports-show-record-35-million-people-enrolled-in-coverage-related-to-the-affordable-care-act.html

[2] Sneed,T. (2022, January 28). Judge notorious for anti-Obamacare rulings has another crack. Retrieved from https://www.cnn.com/2022/01/28/politics/obamacare-reed-oconnor-biden-doj-health/index.html

[3] Sobel, L., Ranji, U., Pestaina, K., Dawson, L., Cubanski, J. (2022, October 26). Explaining Litigation Challenging the ACA’s Preventive Services Requirements: Braidwood Management Inc. v. Becerra. Retrieved from https://www.kff.org/womens-health-policy/issue-brief/explaining-litigation-challenging-the-acas-preventive-services-requirements-braidwood-management-inc-v-becerra/

4) USPSTF. (2021). USPSTF: An Overview. Retrieved from https://www.uspreventiveservicestaskforce.org/uspstf/about-uspstf/task-force-resources/uspstf-overview#:~:text=The%20U.S.%20Preventive%20Services%20Task,prevent%20disease%20and%20prolong%20life.

5) Braidwood v. Becerra, 2022,  https://storage.courtlistener.com/recap/gov.uscourts.txnd.330381/gov.uscourts.txnd.330381.92.0_2.pdf

6) Pierson, B. (2023, March 30). U.S. judge blocks Obamacare coverage mandate for some cancer screenings, PrEP. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/texas-judge-blocks-obamacare-coverage-mandate-prep-cancer-screening-2023-03-30/

7) Klein, H. (2023, March 29). PrEP court ruling could lead to thousands of preventable HIV cases. Retrieved from https://www.ajmc.com/view/prep-court-ruling-could-lead-to-thousands-of-preventable-hiv-cases

8) IHI.(2023) The IHI Triple Aim. Retrieved fromhttps://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx   

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.  

Profiting From Misery Because They Can

By: Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative

Since the passage of the Affordable Care Act (ACA) in 2010, millions of Americans have gained access to health insurance and other forms of healthcare coverage which they were previously unable to afford. According to the U.S. Department of Health and Human Services (HHS), a record 31 million Americans have access to healthcare coverage through the ACA’s Marketplace or Medicaid Expansion coverage (HHS, 2021). And yet, for a significant percentage of Americans, healthcare has not become, despite the name of the law, “affordable.”

When we talk about “affordability,” we often speak in terms of average numbers—the average costs of services and prescriptions; the average costs of insurance premiums and deductibles. By those measures, the ACA has failed:

• The cost of services has increased at an average annual rate of 3.5% per year over the past 20 years (Peter G. Peterson Foundation, 2022). Several factors contribute to this increase in costs, including the introduction of new and innovative technologies leading to more expensive procedures and products, the complexity of the U.S.’s overly complex multi-payor healthcare system that naturally leads to administrative waste, and the decrease of competition as hospital systems consolidate and take over smaller hospitals.
• The cost of prescription drugs has increased on an annual average of around 5% (Keown, 2022). Two HIV drugs, Biktarvy and Descovy (Gilead Sciences), saw price increases of 5.6% in 2021 which, according to a Gilead spokesperson, are offset by rebates and other discount programs (Keown).
• The cost of premiums has increased on an annual average of 11.6% (Antos & Capretta, 2020). Deductibles have risen dramatically, as well, increasing from an average of $2,425 in 2014 to $4,500 in 2020 for Silver Plans offered on Healthcare.gov (Antos & Capretta).

While these costs have increased at a consistent rate, the Real Median Personal Income in the U.S. has largely stagnated since the late-1990s, hovering between $30,000 and $37,000 (U.S. Census Bureau, 2022). This translates to the reality that, while the costs associated with healthcare services and treatments have increased, median incomes have not increased in conjunction to support those increased expenditures.

According to a recent report released by Peterson Center on Healthcare and the Kaiser Family Foundation, although 90% of Americans now have access to some form of health insurance coverage (private, employer-sponsored, or public), medical debt remains a persistent problem for 23 million people—nearly 1 in 10. This is especially true for Americans with lower incomes, Black Americans, and patients with significant medical needs. In terms of age, patients aged 35-64 were more likely than any other demographic to have significant medical debt. In terms of geographic location, people living in the South or in states that have not expanded Medicaid were more likely to have significant medical debt (Rae, et al, 2022). 

Other aspects of the ACA—such as the 80/20 rule, requiring insurers to spend at least 80% of the premiums they collected on medical claims—were designed to limit the profits made by insurance companies. If insurers fail to meet that percentage, they are required to rebate the difference to policyholders. In the early years of the ACA, this resulted in billions in rebates to consumers. However, insurers have successfully devised numerous schemes to ensure that consumers pay more, and insurance provider profit margins stay high.

One such mechanism involves a practice referred to as “Co-Pay Accumulator Programs.”

What Are Co-Pay Accumulators and How Do They Work?

Co-Pay Accumulator Programs are stipulations included in many private and employer-sponsored health insurance plans, often hidden in the “fine print.” Under these programs, money paid to pharmacies and healthcare providers via coupons, assistance cards, discounts, product vouchers, and other third-party sources does not count towards patients’ deductibles or out-of-pocket maximums (OPMs). Since reaching a deductible or OPM makes the insurance company responsible for any further cost of treatment and services covered under a plan, delaying these benchmarks makes patients liable for more costs, increasing the amount they end up paying for prescriptions and other services.

Co-Pay Accumulator Programs save money for insurers by passing along higher costs to patients. For instance, a patient with hepatitis C might be prescribed a direct-acting antiviral (DAA) costing $28,000 per month. Even if an industry co-pay assistance program (CAP) only covers up to 25% of the drug’s cost, meaning $7,000, then just by paying for the first $3,500 dose, the CAP will already meet the patient’s $3,000 deductible. The patient only pays a token amount out of pocket, perhaps $5, while the CAP pays the other $3,495, and all future doses are billed to the insurer.

However, if the plan includes a co-pay accumulator program, that CAP payment will not count towards meeting the patient’s deductible. Instead, the patient uses the CAP for the second dose as well, hitting the CAP maximum of $7,000 yet even then still not meeting their plan’s deductible. With no more help from the CAP, the patient then has to spend $3,000 out of pocket for the next dose before finally hitting their deductible. This saves the insurance company $10,000 by costing the patient $3,000 and the CAP $7,000 before the insurance company even begins helping to pay for the drug. (Hopkins, 2021)

It is our belief that regardless of the source of payment—be it manufacturer coupon, AIDS Drug Assistance Program, or other patient assistance organization, such as the Patient Access Network (PAN) Foundation—all payments should count toward both deductibles and OPMs.

How Many Patients Are Impacted?

According to a 2018 analysis by Zitter Health Insights, 12% of patients with commercial plans were subject to Co-Pay Accumulator Programs in 2018, with 44% of commercial plans including Co-Pay Accumulator Programs. They predicted that 40% of patients would be impacted in 2019 with that number expected to grow annually (Schweitz, 2019). Many patients who are impacted, however, are unaware that their plans contain Co-Pay Accumulators Programs in no small part due to companies using seemingly innocuous language such as “Out-of-Pocket Protection Program” (Express Scripts), “True Accumulation” (Caremark), or “Coupon Adjustment: Benefit Plan Protection Program” (UnitedHealthcare) (Hopkins, 2021).

Photo Source: The Matrix Consulting, LLC

How Can We Address Co-Pay Accumulators?

At the end of 2021, only state-level action had been successfully undertaken to prohibit the inclusion of Co-Pay Accumulator Programs, with twelve states and Puerto Rico having passed such legislation:

• Arizona (HB 166)
• Arkansas (HB 569)
• Connecticut (SB 003)
• Georgia (HB 946)
• Illinois (HB 0465)
• Kentucky (SB 45)
• Louisiana (SB 94)
• North Carolina (SB 257)
• Oklahoma (HB 2678)
• Tennessee (HB 0619)
• Virginia (HB 2515)
• West Virginia (HB 2770)

In 2022, eleven states have introduced legislation to address Co-Pay Accumulators (that the author was able to find):

• District of Columbia (B24-0557)
• Florida (SB 1480) – FAILED; (HB 1063) – FAILED
• Iowa (H 2384)
• Maine (SP 621)
• Minnesota (SF 2136)
• Mississippi (HB 880) – FAILED; (SB 2470) – FAILED
• Missouri (SB 1031)
• New York (A1741); (SB 5299) – FAILED
• South Carolina (H 4987)
• Utah (SB 139) – FAILED
• Washington state (HB 1713) – FAILED; (SB 5610) – PASSED

In addition to state-level actions, Congress recently introduced the Help Ensure Lower Patient (HELP) Copays Act (H.R 5801). The HELP Copays Act, sponsored by Rep. A. Donald McEachin (D-VA-04), would ban co-pay accumulator programs by:

• Updating the Affordable Care Act’s (ACA) definition of cost-sharing to require that all out-of-pocket payments made by or on behalf of a patient count toward the patient’s deductible and out-of-pocket limit. This would end co-pay accumulator programs in marketplace exchange insurance plans. 
• Stipulating that any item or service covered by an employer health plan is part of the essential health benefits (EHB) package and therefore the plan must count any cost sharing toward patients’ annual limits. This would end the ACA’s EHB loophole that allows plans to deem certain categories of drugs as non-essential.

This addition to the ACA would require insurers to count co-pay assistance paid by any third party on behalf of the patient toward their insurance deductible or out-of-pocket maximum (Immune Deficiency Foundation, 2021). The bill has bipartisan support with 20 co-sponsors and 116 state and national organizations sent a sign-on letter via the All Copays Count Coalition to Secretary of Health and Human Services, Xavier Becerra, in support of the HELP Copays Act.

Whom Should We Contact?

While federal legislators continue to work on the HELP Copays Act, people can (and should) reach out to their state legislators to pass legislation at the state level to prohibit insurers from implementing Co-Pay Accumulators by any name. They may find their state legislators online.

At the federal level, the HELP Copays Act continues to sit in the House Committee on Energy and Commerce. People should reach out to their Congressional Representatives, which they may find here.

In addition to contacting members of the House, we urge patients to contact their Senators to ask for a companion bill to be introduced in the Senate. They may find their contact information here.

The ADAP Advocacy Association, Patient Access Network Foundation, and The Matrix Consulting, LLC, invite you to direct your elected representatives to the PAN Foundation’s excellent campaign:

End harmful co-pay accumulator programs online at https://www.panfoundation.org/end-copay-accumulators/.

References:

• Anton, J. R. & Capretta, J. C. (2020, April 10). The ACA: Trillions? Yes. A Revolution? No. Washington, DC: Health Affairs Blog: Health Affairs Forefront. https://www.healthaffairs.org/do/10.1377/forefront.20200406.93812/full/
• Keown, A. (2022, January 04). Drug Price Increases for 460 Drugs in 2022. Urbandale, IA: BioSpace. https://www.biospace.com/article/a-new-year-means-price-increases-for-many-prescription-drugs/
• Peter G. Peterson Foundation. (2022, February 16). WHY ARE AMERICANS PAYING MORE FOR HEALTHCARE? New York, NY: Peter G. Peterson Foundation: Blog. https://www.pgpf.org/blog/2022/02/why-are-americans-paying-more-for-healthcare
• Hopkins, M. J. (2021, April 07). How “Co-Pay Accumulators” Stifle Healthcare Access and Empty Patients’ Wallets. Lost River, WV: Community Education Group: Rural Health Service Providers Network: Publications. https://secureservercdn.net/198.12.144.78/m60.322.myftpupload.com/wp-content/uploads/CoPay_Accumulators-FINAL.pdf
• Immune Deficiency Foundation. (2021, December 02). Support the HELP Copays Act and fight unfair copay accumulators. Towson, MD: Immune Deficiency Foundation: News. https://primaryimmune.org/news/support-help-copays-act-and-fight-unfair-copay-accumulators
• Rae, M., Claxton, G., Amin, K., Wager, E., Ortaliza, J., & Cox, C. (2022, March 10). The burden of medical debt in the United States. Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/brief/the-burden-of-medical-debt-in-the-united-states/?_hsmi=206419781&_hsenc=p2ANqtz--ts2CCK83uE9bi6lOcPJxnqqO0KQG5tOHocn9uAhHCAiYGFqKj4-5sQwvC4s15sMUuMqmLSQsg_QORW4rajQjwpITJZg&utm_campaign=KFF-2022-Health-Costs&utm_medium=email&utm_content=206419781&utm_source=hs_email
• Schweitz, M. C. (2019, January 22). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: Healio: News: Rheumatology: Practice Management. https://www.healio.com/news/rheumatology/20190114/the-costshift-conundrum-of-copay-accumulator-programs
• United States Census Bureau. (2022, March 11). Real Median Personal Income in the United States [MEPAINUSA672N]. Retrieved from FRED, Federal Reserve Bank of St. Louis. https://fred.stlouisfed.org/series/MEPAINUSA672N
• United States Department of Health and Human Services. (2021, June 05). New HHS Data Show More Americans than Ever Have Health Coverage through the Affordable Care Act. Washington, DC: U.S. Department of Health and Human Services: About HHS: News. https://www.hhs.gov/about/news/2021/06/05/new-hhs-data-show-more-americans-than-ever-have-health-coverage-through-affordable-care-act.html

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.