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Aimed Monthly, Volume 2, Issue 9

Welcome to Volume 2, Issue 9 of Aimed Monthly! This month’s issue includes the latest advocacy and regulatory developments regarding copay accumulator adjustment programs (CAAP) and surprising billing, a sign-on opportunity, a migraine resource, and recent executive orders.


Aimed Alliance Asks NY Assembly Members to Support CAAP Bill

On September 25, 2020, Aimed Alliance asked New York assembly members to support the passage of A8246, a bill that would limit health insurers’ use of copay accumulator programs. In particular, A8246 prohibits health insurers from adopting copay accumulator programs for a branded drug unless a medically appropriate generic medication is available. The bill is crafted to incentivize patients to use lower cost medications only when such medications are available and deemed medically appropriate, but it recognizes that copay accumulator programs are inappropriate where no generic alternative exists. As such, A8246 strikes a balance between the interests of health plans and pharmaceutical manufacturers without unreasonably penalizing patients for relying on financial assistance. Our letter is available here.
Aimed Alliance Joins Two New Coalitions

This month, Aimed Alliance joined Consumers for Quality Care (CQC) and the World Patients Alliance. CQC works to ensure that patients, and their right to high-quality health, remain at the front of the health care debate. They seek to provide a voice for health care consumers to tell their stories and demonstrate to policymakers the imperative that is quality care.

The World Patients Alliance (WPA) is an umbrella organization of patients and patients' organizations around the globe. WPA seeks to ensure that all patients have access to safe, high quality, and affordable health care everywhere. WPA also works toward ensuring patients have an active role to play in all the stages of healthcare, including planning, provision, monitoring, research, and evaluation of health services.
Sign On Opportunity

The Alliance for Balanced Pain Management is asking groups to sign on to a letter regarding a proposed rule by the Center for Medicare and Medicaid Services (CMS) titled “CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies.” The proposed rule would combine different types of drugs into a single group for payment purposes. One type of drugs, referred to as 505(b)(2), are brand name medications that build on the research that the U.S. Food and Drug Administration (FDA) has used to approve past medications. Brand name drugs approved under this pathway have new or unique features not available in previously marketed drugs (e.g., they provide changes to dosage form, strength, route of administration). As such, they are innovative and have higher costs associated with their development compared to generics. The other drugs in this group are primarily generics with much lower costs. The proposed rule would reimburse physicians and surgery centers based not on the cost of the medication their patient actually uses but on the average cost of the entire group of drugs. As a result, drug makers could be disincentivized from developing new 505(b)(2) medications considering that the process to get them approved is more costly than the process for generic medications. Read AfBPM’s letter here. If you are interested in signing on, click here.
Migraine Toolkit

The Society for Women’s Health Research has developed a new toolkit to help patients navigate their migraine care with easy-to-understand information about diagnosis and treatment, as well as tips on interacting with health care providers and health insurance companies to achieve the best possible outcomes. The toolkit also helps individuals find information that will help them integrate wellness practices into their daily life.
Rheumatic Disease Patient Survey

The American College of Rheumatology conducted a national survey of individuals living with rheumatic disease to gain a better understanding of the quality of life issues that patients may face. Key findings from the survey include:
  • About 66% of patients reported having a telehealth appointment with their rheumatologist within the past year, with COVID-19 reported as the most common reason.
  • Out-of-pocket costs more than doubled from 2019. The median annual out-of-pocket treatment cost in 2020 was $1000 - up $475 from last year.
  • Almost half (46.17%) of patients reported that their insurer subjected them to step therapy requirements.
  • About another half (47.94%) reported that their provider needed to obtain prior authorization before getting a prescription.
  • A majority (68.7%) of respondents reported their disease sometimes feels invisible because they don't "look sick" to most people.
Exponential Growth in PBM Formulary Exclusions Raises Concerns

A new report from Xcenda found that, between 2014 and 2020, the number of medicines excluded by one or more pharmacy benefit managers (PBMs) increased by an average of 34% per year, with the exclusions reaching into therapeutic areas once considered untouchable, such as oncology. Each year, PBMs issue lists of drugs they will exclude from coverage. Recently, the practice of formulary exclusions has grown to exclude nearly one  thousand prescription medicines across three PBMs’ formularies—CVS Caremark, Express Scripts, and OptumRx. In 2019, these three PBMs handled 74% of all prescriptions processed in the U.S. and managed pharmacy benefits for approximately 256 million Americans. 

Executive and Legislative Updates


Most Favored Nations Executive Order  

On September 13, 2020, the White House issued its highly anticipated “most favored nation” executive order. It states that the Medicare program should not pay more for Part B or Part D prescription drugs or biologics than the same low prices available in other developed countries. However, those countries implement price controls that result in drug rationing, and they measure cost-effectiveness using quality-adjusted life-years (QALYs), a fundamentally flawed mechanism that devalues human life. QALYs assign a lesser value to individuals who have health conditions, are older, or who have a disability than those who are younger and considered healthy. As such, the rule could significantly impact patients’ ability to access new medications. The executive order instructs the Department of Health and Human Services (HHS) to develop a rule on this issue, which should provide the public with an opportunity to comment.   


White House Releases Surprise Billing Executive Order 

On September 24, 2020, the White House issued an executive order on surprise billing. In particular, the executive order requires HHS to work with Congress to pass legislation by December 31, 2020. If Congress does not enact legislation by then, the executive order instructs HHS to take administrative action to prevent surprise billing. However, the executive order does not explain what action should be taken. Generally, the two most commonly proposed solutions include 1) setting payment rates that out-of-network providers must accept; and 2) requiring providers and insurers to engage in arbitration. Providers support the arbitration solution, whereas insurers support the payment rate solution.  


California Enacts Law to Improve Mental Health Coverage 

This month, California Gov. Gavin Newsom signed SB 855 into law, which is intended to improve coverage of mental health and substance use disorder (SUD) treatment. Under the California Mental Health Parity Act, which was enacted in 2000, health care plans offered in the state that provide hospital, medical, or surgical coverage are required to also provide coverage for the diagnosis and medically necessary treatment for mental health conditions, including SUDs. However, over the years, health plans have exploited a loophole by creating their own definitions of “medically necessary,” thereby finding ways to exclude mental health and SUD services from coverage. In efforts to close that loophole, SB 855 requires medical necessity to be based on generally accepted standards of mental health and SUD care rather than insurers’ internal policies. Additionally, plans must now cover basic health services, intermediate services, and prescription drugs. The bill also prohibits health plans from limiting benefits or coverage for mental health and SUDs to short-term or acute treatment. 



In Case You Missed It


GAO Report Reveals Insurance Reps’ Deceptive Practices When Selling Junk Plans 

According to a new report released by the U.S. Government Accountability Office (GAO), some health insurance sales representatives are engaging in deceptive practices when selling short-term limited duration health insurance plans. Such plans do not need to comply with the Patient Protection and Affordable Care Act (ACA) and are permitted to discriminate on the basis of preexisting condition. 

GAO performed 31 undercover tests to select sales representatives and stated that they had pre-existing conditions, such as diabetes or heart disease. In ten of the tests, the sales representatives either were not consistent or clear in their explanation of the type of coverage and plans they were selling or engaged in potentially deceptive marketing practices, such as claiming the pre-existing condition was covered when the health plan documents GAO received after purchase said otherwise. GAO plans to refer the latter cases to the Federal Trade Commission and corresponding state insurance commissioners’ offices. Read more here


Members of Congressional Health Care Committee Ask CMS To Reject GA Plan to Leave Exchange  

Earlier this year, Georgia submitted a waiver to CMS requesting to exit the federal health care exchange (i.e., without creating a state-based exchange as an alternative. Instead, the state proposed to rely exclusively on private vendors. Congress members and patient advocates called on CMS to reject Georgia’s waiver this month, arguing that the waiver is “unlawful, will significantly reduce access and enrollment in comprehensive health insurance, and will expose consumers to greater financial risk by encouraging enrollment in junk plans.” 


Supreme Court to Hear ACA Case in Less than 45 Days  

On November 10, 2020 (less than 45 days away), the Supreme Court of the United States will hear oral arguments in California v. Texas, the case challenging the constitutionality of the ACA. A decision is expected in early 2021. If the ACA is struck down in its entirety, vital health care protections will cease to exist, including the requirements that health plans not discriminate on preexisting conditions, offer coverage of essential health benefits, cover children under the age of 26 on parents’ health plans, expand Medicaid coverage to individuals with income levels lower than 133 percent of the federal poverty guidelines, not cancel or rescind coverage after the plan year has begun except in instances of fraud, and offer plans through state or federal exchanges. Read more about the case here.

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