Three Guiding Principles for Patient-Centered Decision-Making in Washington for 2021

Three Guiding Principles for Patient-Centered Decision-Making in Washington for 2021
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Millions of patients most vulnerable to the effects of COVID-19 are not only feeling left behind in 2020, but are facing more intense health and economic challenges as policymakers and regulators make one poor policy decision after another.

In 2021, Washington needs to take a different approach to solve systemic healthcare spending challenges. As President-Elect Joe Biden begins to assemble a team to guide future healthcare policy decision-making, and as the incoming 117th Congress prepares to do the same, it should start with three core principles that put patients at the center of their own care. The president-elect, federal legislators, and regulators at HHS should be guided by policies that protect patient access to assistance programs, maintain the integrity of patient/provider choice, and take payers and pharmacy benefit managers (PBMs) out of treatment decisions.

First, Washington should protect patients from copay accumulator adjustment programs and other harmful protocols that negatively impact treatment access and affordability, and that place insurance companies and PBMs in the middle of decisions that should remain between a patient and their doctor. Health insurance companies have increasingly started to include copay accumulator adjustment program policies into beneficiary health plans that undermine the value of copay assistance programs. If a patient’s policy includes a copay accumulator, the copay assistance they use to afford their medications won’t count towards their annual out-of-pocket burden. In this scenario, patients are often faced with exorbitant costs at the pharmacy counter when their copay assistance runs out and are forced to pay more out of pocket or, in many cases, abandon their current treatment altogether.

While state legislatures in Arizona, Georgia, Illinois, Virginia, West Virginia, and Puerto Rico have all taken action to ban copay accumulator policies, the federal government determined that health plans could sneak these programs into the fine print of 2021 health policies. This comes despite evidence from the Centers for Disease Control and Prevention (CDC) that out-of-pocket costs can reduce patient adherence to necessary therapies, which can increase costs in other parts of the healthcare system.

The fact remains that patients need copay assistance whether they have either individual or employer insurance, or Medicare. In August, more than 150 organizations urged the Department of Health and Human Services (HHS) Office of the Inspector General to lift the ban of copay coupon cards in the Medicare Part D program for America’s seniors. 

Copay accumulators are just one barrier facing patient and provider choice. In other cases, insurance companies use tactics to control costs that undermine the role of providers and lead to unnecessary delays in treatment, or even flat-out denials of care. Prior authorizations for medications, for example, are required when a doctor chooses to prescribe a medication not on the health insurer standard formulary, but that the doctor feels is the best course of treatment for the patient. Step therapy (also known as “fail first”) requires patients to try, and fail, on one or more prescription drugs chosen by their insurance company (not their healthcare professional) before gaining access to the drug that was recommended by their provider.

These and other insurance protocols that require patients to jump through hoops to get the best treatment have no place in our healthcare system. Federal and state legislation should protect patients by preventing health insurance plans from making benefit, coverage, or access decisions that damage the role of the healthcare provider. It’s precisely the reason why federal legislation exists to delay the 2021 policy on copay accumulators and protect patients from step therapy protocols.

Second, Washington should avoid policies that rely on foreign models and controversial drug value assessments to determine drug prices and access. At the heart of the way many foreign nations determine treatment cost and access decisions is the Quality Adjusted Life Year (QALY), a methodology that uses an inappropriate, one-size-fits-all approach for every patient to determine if a drug’s price is reasonable relative to the value it creates (as determined by…whoever is conducting the analysis). The QALY is completely subjective, leading to discrimination against America’s seniors, those with disabilities, and patients with rare conditions, whose lives are considered less valuable in the QALY framework.

The HHS Secretary has even publicly opposed the use of the QALY, and the Affordable Care Act bans the use of QALY and similar drug value assessment tools to determine Medicare coverage, a method the Institute for Clinical and Economic Review (ICER) uses to produce deeply flawed drug-value reports that are commanding attention in state capitals and amid COVID-19.

Countries that have relied on the QALY and similar approaches to determine treatment coverage have demonstrably limited patient access to critical therapies. In the United Kingdom, price control policies denied cancer patients access to 25 critical drugs, leading to worse outcomes and even death. Still, even President-Elect Joe Biden hinted that he may use a similar approach to drug pricing. During a pandemic and beyond, we should avoid policies that put treatments and pricing decisions into a mathematical blender that doesn’t factor in the true value these therapies provide to so many patients, and to society at large.

Third, Washington should improve treatment affordability by first expanding the implementation of out-of-pocket prescription drug cost caps for seniors in Medicare and Americans with private insurance and then sharing discounts and rebates with patients. President Trump took the first step in this direction when he instituted a $35 out-of-pocket monthly cost cap on insulin for seniors in Medicare Part D this spring. But it’s only the first step. Polling shows that a majority of American adults support legislation to cap or limit what seniors pay out-of-pocket for prescription drugs in Medicare Part D.

And if insurance companies and PBMs don’t pay the full price for medicines, patients shouldn’t have to, either. On average, pharmaceutical companies rebate about 40 percent of a medicine’s list price back to health insurance companies and PBMs. But patients often don’t see those discounts when they purchase their treatments. Rebates and discounts should be shared with patients at the pharmacy counter or used to lower patient premiums.

As we look ahead to 2021, policymakers new and returning, patients, providers, and all stakeholders must come together, reset, and realign around patient-centered healthcare principles that are proven to reduce costs and maintain the integrity of patient/provider choice. Until we do, patients will continue to be subject to the power of insurance companies, drug middlemen, and dangerous foreign pricing models.

Americans, often forgotten by their healthcare policymakers in the middle of a global pandemic, deserve far better.

Randall Rutta is president and CEO of the American Autoimmune Related Diseases Association. Carl Schmid is the executive director of the HIV+Hepatitis Policy Institute and co-chair of the Presidential Advisory Council of HIV/AIDS.

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