I Benefit from HIV Co-pay Assistance Programs; CMS Wants to Change That

By: Guy Anthony, President/CEO, Black, Gifted & Whole Foundation, and Board Member, ADAP Advocacy Association

I found myself both shocked and appalled when reviewing the latest Notice of Benefit and Payment Parameters (NBPP) for 2021 issued by the Centers for Medicare and Medicaid Services (CMS) recently. The proposed NBPP, which is released annually, attempts to exclude manufacturer coupons from being counted towards a patient's annual deductible on cost-sharing.

As someone that has been living with HIV for over a decade, and a direct beneficiary of the drug manufacturer co-pay assistance program, I have an intimate understanding of the far-reaching and potentially devastating effects this decision could have on those in the HIV and HCV community.

Photo Source: Sermo

How Many People Will Be Affected by the Changes?

Over one million people in the U.S. live with HIV and over three million live with chronic HCV. Those who have these conditions come from all walks of life. They're certainly not limited to the LGBTQIA+ community. However, those from disadvantaged backgrounds are much more likely to have the disease than those that hail from affluent socioeconomic backgrounds.

According to the Centers for Disease Control and Prevention (CDC), HIV prevalence in U.S. poverty areas matches those of countries designated as having a generalized HIV epidemic such as Burundi, Ethiopia, and Haiti. What's more, HIV prevalence rates in urban poverty areas are inversely related to annual household income – the lower the income, the higher the HIV prevalence rate.

In other words, the poorer you are, the more at risk you are of contracting the disease. Furthermore, due to the nature of chronic diseases such as HIV, those living with these conditions find it much harder to secure long-term work due to issues surrounding immunodeficiency. This is something I have experienced myself, and employment with HIV is not easy to maintain.

Since a great deal of HIV and HCV cases are found in lower-income households, these changes are going to have a dramatic impact on a considerable proportion of those one million-plus people living with the condition.

How Does Co-Pay Assistance Help Those with HIV?

As you know, those with chronic conditions such as HIV and HCV have had the financial burden of the disease reduced thanks to co-pay assistance programs provided by drug manufacturers in conjunction with additional support from the AIDS Drug Assistance Program (ADAP). Co-pay assistance ensures that financially-challenged individuals can receive the drugs they need to live with the disease.

Everyone living with HIV and HCV knows and appreciates how important these programs are to the community. I've long advocated as part of my awareness campaigns that co-pay assistance and ADAP are pretty much the reason why HIV is no longer a death sentence, since many patients can better "afford" to stay alive. But this move to exclude manufacturers coupons by the CMS is going to hit those who need financial relief the most.

What is the Likely Fallout from These Proposed Changes?

The most immediate ramification will come in the form of reduced medication adherence. Suddenly those that enjoyed financial relief will have to deal with the impact of high deductibles and high cost-sharing expenses. Most individuals living with HIV and HCV need to take at least two antiretroviral drugs every single day. It doesn't matter who you are; anyone can see that these changes will force some people to choose between money and medication. It makes me sick that we live in a country that people with chronic conditions such as HIV might not be able to get access to necessary drugs, as prescribed by their doctor, as a result of a lack of financial means.

I know of individuals who potentially face a situation of not being able to afford the medication they need to live a normal life. One of those people happens to be me. It seems that the constitutional right to life and liberty has been thrown out the window. I think this has a lot to do with the continued stigmatization of conditions such as HIV and HCV. I am no less of a person because I have HIV, no one chooses to have this disease, so why have the rights of individuals within this community being gradually eroded?

Photo Source: Novartis

Help Us to Creat Change!

The CMS proposal to exclude manufacturer coupons would have genuinely concerning effects on the affordability of many medications within the regimens of HIV and HCV patients, including myself. In many cases, those living with these diseases will have to bear the financial burden as a result. For some, that burden will be too much.

As is the case for a lot of situations in life, it's going to be those without sufficient means that are going to find themselves the most adversely affected.

We need your help to stop this becoming a reality. Please contact your member of Congress and ask them to help stop this from happening to our community.

References:

• Denning, MD, MPH, Paul, and Elizabeth DiNenno PhD (2019, December 11). Communities in Crisis: Is There a Generalized HIV Epidemic in Impoverished Urban Areas of the United States? Centers for Disease Control & Prevention. Retrieved online at https://www.cdc.gov/hiv/group/poverty.html.
• McManus, K. A., Engelhard, C. L., & Dillingham, R. (2013). Current challenges to the United states' AIDS drug assistance program and possible implications of the affordable care act. AIDS research and treatment, 2013, 350169. https://doi.org/10.1155/2013/350169

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.

CMS Declines To Enforce New Co-Pay Rules It Put In Place

By: Marcus J. Hopkins, Policy Consultant

One of the arguably good changes brought forth by the Affordable Care Act (ACA; AKA – Obamacare) was the ability to use Ryan White (RW) Part B funds to purchase and pay private insurance premiums and co-pays for AIDS Drug Assistance Program (ADAP) clients. This, in addition to shifting some clients off of RW and onto state Medicaid programs in those states that expanded Medicaid, allowed state RW programs to shift some expenditures and costs off of their budgets by no longer paying directly for medications and, in some states, treatment costs.

One of the negative consequences of the ACA’s implementation has been the creation and proliferation of so-called “Co-Pay Accumulator Programs” – management tools used by Pharmacy Benefit Managers (PBMs) and other health plans that excludes co-pay assistance coupon and program payments from counting toward patients’ deductibles (Schweitz, 2019). This concept essentially allows insurers and PBMs to accept the payments received from the utilization of these co-pay coupons and Patient Assistance Programs (PAPs), not count those payments toward patients’ deductibles, and later demand and collect additional deductible payments after the co-pay assistance runs out for patients.

This practice has been widely criticized in a time when pharmaceutical prices have been (rightly) deemed out of control, too high, and unconscionable. Patients rely upon these manufacturer coupons, PAP assistance, and other discount programs to reduce the high cost of drug co-pays to as little as $5 or no cost from potentially hundreds of dollars per medication fill.

Photo Source: AIMED ALLIANCE

The current administration has repeatedly promised that it would lower the cost of prescriptions, though it has done little to deliver on said promise. One of the few positive steps it had taken was the announcement in its 2020 Notice of Benefit and Payment Parameters rule that “…co-pay assistance from drug companies must count towards a patient’s deductible and out-of-pocket maximum in most cases.”

That decree lasted about as long as any other policy decree from this administration.

On August 26th, 2019, the Center for Consumer Information and Insurance Oversight (CCIIO) released an FAQ (found here) stating that this rule, set to go into effect on January 1st, 2020, will now not be enforced, nor will states be required to enforce the pro-patient rule, because enforcing it might conflict with rules set forth by the Internal Revenue Service (IRS) that allows High Deductible Health Plans (HDHPs) to not count co-pay assistance toward deductibles.

Photo Source: CMS

So, essentially, the health insurance companies win.  Again.  And again.  And again.

ADAP funds may be used to pay for clients’ co-pays, premiums, or both, depending upon the state, and for those clients who live in states where ADAP only pays for premiums, they may rely upon co-pay coupons to afford their medication co-pays.

To put this in personal terms, my Biktarvy (Gilead) co-pay is $250/month. Because I live in WV, the state covers that co-pay amount. However, if I lived in another state where that wasn’t the case, I could potentially use Gilead’s Advancing Access® Medication Co-Pay Card, which pays $3,600 annually toward co-pay costs. That amount would pay for 14 months of my $250 co-pay, essentially delivering a medication for free for an entire year…unless the PBM that services the insurance plan’s prescription program uses a Co-Pay Accumulator Program, so that none of those medication co-pays count toward my deductible.

For anyone who thinks that this move by the Centers for Medicare and Medicaid Services (CMS) is an accident, don’t kid yourself: this isn’t a glitch; it’s a feature. This administration’s CMS has consistently moved in ways that raise prices and complicate healthcare access for patients, from authorizing (likely unconstitutional) work requirements for Medicaid programs in Arizona, Arkansas, Indiana, Kentucky, Michigan, New Hampshire, Ohio, Utah, and Wisconsin, to changing the way the Modified Adjusted Gross Income (MAGI) – the measurement used to calculate eligibility for assistance programs – is calculated. CMS Administrator, Seema Verma, has consistently ranked high on the Cruella de Vil Scale of Human Empathy, frequently siding against the interests of patients in her administration of federal healthcare programs.

Caught in the middle of this battle between private insurance profits and purported (but undelivered and undeliverable) savings for federal programs is the patient, who has seen their access to medications consistently slip further and further out of grasp. It is time, once again, for Americans to decide which is more important: the value of money or the value of human life. Sadly, I’m not at all confident that we will make the right decision.

References:

• Schweitz, M.C. (2019, January). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: SLACK Incorporated: Healio: Healio Rheumatology: Practice Management. Retrieved from: https://www.healio.com/rheumatology/practice-management/news/print/healio-rheumatology/%7B04769e45-fca4-4ce6-90be-8f441d6afc7d%7D/the-cost-shift-conundrum-of-copay-accumulator-programs

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

Rx Drug Coupon Concerns Pit Prices Against Patients

Guest Blog By: Marcus J. Hopkins, Blogger

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

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

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

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

Photo Source: Consumer Reports

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

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

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

Kaiser Family Foundation Publishes Fact Sheet on AIDS Drug Assistance Programs (ADAPs)

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

The Kaiser Family Foundation (KFF) recently published an excellent Fact Sheet on the AIDS Drug Assistance Programs (ADAPs), which are authorized under the Ryan White CARE Act. ADAP provides medications for the treatment of HIV disease for people who are uninsured, or under-insured. The ADAP Advocacy Association commends KFF for making this important educational tool available.

Download the KFF Fact Sheet.

The KFF Fact Sheet is broad, in that it provides relevant background information about ADAP, as well as budgetary summaries, drug formularies, and program expenditure breakdowns. It also highlights information on eligibility requirements, client demographical data, cost containment measures, drug purchasing models, and pertinent information related to Medicare Part D. It serves as a useful tool, especially for advocates trying to educate lawmakers at the federal, state, and local levels.

Did you know that ADAPs are not entitlement program?[1]

Did you know that State funding only accounted for 6% of the overall ADAP budget?[2]

Did you know that the average amount spent on drug purchases and co-payments was $8,663?[3]

Did you know that 257,396 people were enrolled in ADAPs in CY 2015, ranging from 140 in Wyoming to more than 35,000 in California?[4]

Did you know that not all State ADAPs received rebates from drug companies?[5]

These interesting facts, along with others can be viewed online at http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.

Source: Kaiser Family Foundation

The National Alliance of State & Territorial AIDS Directors (NASTAD) released its 2017 National ADAP Monitoring Project Annual Report earlier this year, which tracked state-by-state programmatic changes, emerging trends, and latest available data on the number of clients served, expenditures on prescription drugs, among other things. The Fact Sheet on the AIDS Drug Assistance Programs (ADAPs) published by KFF certainly complements the comprehensive analysis done by NASTAD on the program, annually.

Of particular interest to the ADAP Advocacy Association — as well as many ADAP stakeholders — is the overview on the drug formularies provided in the KFF Fact Sheet. These drug formularies are the foundation by which states mold their strategies to promote access to care and treatment. According to the KFF Fact Sheet, some key points of interest include:[6]

• Six (6) states had an open formulary
• All states offered all of the drugs identified in the “recommended regimens” in the nation’s HIV treatment guidelines.
• Of the 45 ARVs currently available (including multi-class combination products and generics), ADAP formularies covered between a low of 37 drugs in Arkansas to all 45 in 27 states.
• In addition to ARVs, many ADAPs provide access to drugs to treat opportunistic infections and HIV co-infection (e.g. treatment for hepatitis).

The importance of state drug formularies cannot be understated!

Dating back to the inception of this organization ten years ago, we have routinely sounded a cautionary alarm that the ADAP waiting lists (which were officially eliminated several years ago) are only the “tip-of-the-iceberg” because other cost containment measures restrict access to care and treatment. Among them, restrictive drug formularies. By limiting the treatment regiments available to people living with HIV/AIDS, states are indeed restricting access to care and treatment. These restrictions can also impact treating other chronic conditions associated with the disease, such as lipodystrophy or diarrhea.

Concerns over restricted state drug formularies was charactered as follows by Eddie Hamilton, Founder of the ADAP Educational Initiative: "The increased cost or additional effort of restricted formularies are a barrier for ADAP clients and may cause them to abandon the prescription which their doctor has written for a medically necessary reason. Many of the excluded medications are to combat side effects and co-morbidities caused by the primary antiretroviral regimens. These restrictions will continue to compromise their health and will lead to costly complications such as hospitalizations, lower medication adherence and overall higher healthcare costs."

To be fair, State ADAPs are often forced to face the harsh reality of prioritizing limited resources, especially since not all of them receive state matching funds or pharmaceutical rebate dollars. Also to NASTAD's credit, they make available another great resource, specific to ADAP drug formularies. Download the 2016 ADAP Formulary Database.

To learn more about the KFF Fact Sheet on AIDS Drug Assistance Programs, or other HIV-specific information and resources offered by the Kaiser Family Foundation, visit http://www.kff.org/graphics/hivaids/.
__________

[1] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.
[2] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.
[3] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.
[4] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.
[5] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.
[6] Kaiser Family Foundation (2017, August 16); AIDS Drug Assistance Programs (ADAPs); HIV/AIDS. Retrieved from http://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.