In January of 2020, the Centers for Medicare and Medicaid Services (CMS) proposed a new rule that could increase the out-of-pocket costs for people who take prescription medication for hepatitis B in the U.S. The proposed rule states that health insurance companies would be able to collect patient coinsurance through pharmaceutical manufacturer financial assistance. However, the insurance companies will be allowed to disregard any coinsurance paid with copay assistance when calculating how much the patient has paid toward their deductible and annual out-of-pocket (OOP) limit.
This proposal – titled 2021 Notice of Benefit and Payment Parameters – reverses a recent ruling that would have required health insurance companies to count the value of manufacturer copay assistance toward an enrollee’s annual deductible and OOP limit in most circumstances1. This rule acknowledged that manufacturer copay assistance helps lessen the financial burden of medications for patients. In the US, prescription drugs can be extremely costly, making manufacturer’s copay assistance programs necessary for many patients. For example, brand name treatments are often expensive in order to help pharmaceutical companies earn back the costs of the research and time spent making the medication. Sometimes, the brand name treatments are the only ones that are available, like Vemlidy, or the only version that a person can take. A reversal of the rule would mean that hepatitis B patients and those living with other chronic illnesses may have to pay a larger amount of out-of-pocket costs for their medications.
To understand the significance of this change, we first need to understand what a copay accumulator is.
What is a Copay Accumulator Program and How Does It Work?
A copay accumulator – or accumulator adjustment program – is a strategy used by insurance companies and Pharmacy Benefits Managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending. What does this mean?
Previously, a person could receive financial assistance from companies that make a drug, and that would count towards their deductible and/or out-of-pocket costs, depending upon the insurance plan. Pharmaceutical companies often provide financial assistance (such as a co-pay card) to help underinsured individuals afford expensive medications. This means that the person paying for the drug would end up saving money, often thousands of dollars.
Why Is This an Issue?
As the AIDS Institute explains it, “ … the trend in health insurance benefit design is to shift more of the cost of health care to patients through high deductibles and coinsurance rates …In order to afford the medicine they need, patients increasingly rely on manufacturer copay assistance.” With copay accumulators, the individuals who need assistance the most will be unable to receive it, and will end up paying more for their treatments.
Below is an example of a copay accumulator program from the Patient Access Network (PAN) Foundation:
As shown in the above image, with a copay accumulator program – meaning her manufacturer’s assistance is no longer counted toward her out-of-pocket limit- the consumer ends up paying more, while the insurance company is able to reduce the amount they are paying.
Copay accumulator programs are making life-saving treatments increasingly inaccessible. Research shows that the more out-of-pocket costs a person has to pay, the more likely they are to abandon their medication. Once on a hepatitis B medication, stopping suddenly or only taking it once in a while can cause flares and lead to an even higher risk of liver damage.
In the United States, many of those who are living with hepatitis B come from underserved populations with limited access to healthcare. Oftentimes, cultural differences and language barriers can make it difficult to access and utilize the services they need. Now, copay accumulators are making the navigation process even more complex and placing a higher cost burden on patients.
1 The rule required insurance companies to count manufacturer copay assistance toward a patient’s deductible and OOP limit for all brand name drugs for which there is no generic alternative and in cases where the patient gained access to the brand name drug through an insurance plan’s appeals or exceptions process.
speak with Andrew Vaillant, Ph.D., Chief Scientific Officer at Replicor at the annual International HBV Meeting in Melbourne, Australia. Dr. Vaillant gave us an inside look at REP 2139 – their drug candidate developed for the treatment of chronic hepatitis B and HBV/HDV coinfection. REP 2139 is a nucleic acid polymer that removes surface antigen (HBsAg) and as part of combination therapy, has achieved functional cure for chronic HBV (sustained HBsAg loss) and sustained clearance of HDV infection from the blood in early phase II proof of concept clinical trials it has completed to date. 
diagnosed with hepatitis B, or maybe you are spending this year alone because you are scared to begin a relationship. This year, instead of focusing on others, take Valentine’s Day to love yourself – and your liver! 
produced by a mold that grows on crops like corn, peanuts, and tree nuts. Aflatoxins are more common in warm, humid parts of the world, such as African countries and areas with tropical climates. Before eating any grains and nuts, check for any signs of mold. If the food appears to be moldy, do not consume it. The World Health Organization also 
apoptosis and necroptosis in the context of hepatitis B infection under the direction of PI Dr. Roshan Thapa. David also mentors high school students from local area schools as part of an after-school program in the new teaching lab at the PA Biotech Center. His passion is learning, teaching and collaborating with others to conduct research to better understand nature. 
Hepatitis Summit in Abuja, FCT. The meeting was the flagship event in the country that brought together 26 states Ministry of health officials, academia, and civil society groups to engage on ways to accelerate hepatitis elimination in the country. The event was supported by Gilead Sciences and Roche Products Limited, with technical support from Clinton Health Access Initiative.
of this is out-of-pocket spending, with only a small minority of Nigerians (approximately 4-5%) covered by health insurance. Costs of testing and treatment pose significant barriers to accessing viral hepatitis care, as tests, treatments, and vaccines must be paid for privately, and there is often limited availability of supplies.
government. The program provides affordable HCV RNA @ $35 and generic DAAs/month @ $80/month. CHAI through its access program has succeeded in negotiating costs of HCV diagnostics in some health centres across Nigeria, such as Lagos, Abuja, and Kwara, where patients can access affordable HCV RNA tests.
