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Aimed Monthly, Volume 1, Issue 6

Welcome to Volume 1, Issue 6 of Aimed Monthly! In this issue, we have a slew of exciting developments to share with you, along with some federal regulatory updates and the launch announcement of our new coalition. Start reading below!


Administrative Delay
Health care advocates have been anticipating the release of final regulations from the Trump Administration that could have sweeping impacts on the U.S. health care system. Those expectations were muted on May 22, 2019, when the administration released its Spring Regulatory Agenda, which includes an overview of forthcoming regulatory actions. The health policy community expected the imminent release of a proposed rule regarding the International Pricing Index demonstration project and a final rule regarding the Anti-Kickback Statute’s safe harbor provisions that would change the drug rebate system. However, the regulatory agenda revealed that both rules have been delayed until later in the year.
Weighing In
On May 23, 2019, the Senate Health, Education, Labor & Pensions (HELP) Committee released a discussion draft of the Lower Health Care Costs Act of 2019. The discussion draft proposes to address factors that contribute to rising health care costs but leaves others untouched. Aimed Alliance submitted a comment to the Committee thanking it for heeding some of our past recommendations and emphasizing the importance of addressing the rest. This included asking the Committee to prohibit copay accumulator programs in employer-sponsored health insurance, expanding coverage of telehealth in Medicare, and imposing a fiduciary duty on pharmacy benefit managers.
Hands Off 
On May 16, 2019, CMS announced the final drug pricing rule for Medicare Advantage (MA) and Part D plans. The draft of this rule, originally issued in November 2018, would have allowed MA and Part D plans to exclude coverage of medications that are in the Six Protected Classes in certain situations. Aimed Alliance opposed this proposal because it could have prevented vulnerable patients, such as those with cancer, epilepsy, and HIV, from accessing these medications. In the final rule, CMS heeded our recommendations and chose to abandon the proposed changes to the Six Protected Classes.
Healthy Digestion 
Aimed Alliance recently launched an initiative to advocate for patients with exocrine pancreatic insufficiency (EPI), which is a condition characterized by the absence of the exocrine enzyme that is required for the body to be able to digest food. EPI is commonly associated with other conditions that affect the pancreas, including cystic fibrosis, chronic pancreatitis, and pancreatic cancer. Aimed Alliance is assembling a coalition of advocacy groups that will comprise the Exocrine Pancreatic Insufficiency Coalition (EPIC), which will jointly advocate for this patient population. You can visit the coalition’s page on our website to keep up with our activities.
Empowering Patients 
On May 24, 2019, Aimed Alliance Staff Attorney John A. Wylam joined Patient Power founder Andrew Schorr to discuss recent developments that could impact patients with cancer. This episode of Ask Aimed Alliance touched on state and federal legislative activity regarding step therapy, prior authorization, and copay accumulators, and provided timely updates on significant federal regulations that could impact Medicare beneficiaries. Additionally, Patient Power published two blog posts that were authored by John. The first blog post provides guidance for employees facing workplace discrimination due to their cancer diagnosis while the second blog post educates individuals with cancer about what they can do if their insurer refuses to provide coverage for treatment.

Where We've Been

  • On May 31, 2019, Aimed Alliance Staff Attorney John A. Wylam attended the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • On June 3-4, 2019, Aimed Alliance Counsel Stacey L. Worthy and Shruti Kulkarni represented patients and providers at 2019 BIO International Convention in Philadelphia, PA.

Legislative Update

  • On May 13, 2019, Maryland enacted a nonmedical switching law that requires health plans to establish a process that will allow patients to receive coverage for a prescription medication or medical device that is not on the health plan’s formulary. The new law will take effect on October 1, 2019.
  • On June 3, 2019, Nevada enacted a law that will require the state to conduct a study on the cost of prescription medications. This effort will hopefully contribute to the national conversation about drug pricing by shedding light on the causes of rising drug costs.
  • On June 3, 2019, the Chair of the New York Senate Health Committee, Gustavo Rivera, introduced S. 6303, which would require health plans to count the value of third-party financial assistance towards enrollees’ deductibles and maximum out-of-pocket costs. New York joins several other states in introducing legislation to address copay accumulator programs and could be the fourth state to enact a law prohibiting them after Arizona, Virginia, and West Virginia enacted similar laws this year.

In Case You Missed It

  • On May 8, 2019, the Let MI Doctors Decide initiative issued a report card that graded the nation’s top health insurers and pharmacy benefit managers on their ability to provide access to medications for patients with autoimmune conditions. This report card analyzed the extent to which health plans limit coverage for medications to treat the five most common autoimmune conditions, which includes Crohn’s disease, multiple sclerosis, psoriasis, psoriatic arthritis, and rheumatoid arthritis. Review the report card to understand why most Medicare Advantage and Medicare Part D plans received a failing grade.
  • On May 14, 2019, the National Kidney Foundation jointly hosted an event with Alliance Member Amarin on Facebook Live that focused on educating patients about managing their cardiovascular risk. This event featured a conversation between a patient, a nephrologist, and a cardiologist, and was hosted by a broadcast journalist and medical reporter.
  • On May 17, 2019, the Society for Women’s Health Research (SWHR) published a paper that was concurrently featured in the June 2018 issue of Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association titled “Understanding the impact of sex and gender in Alzheimer’s disease: a call to action.” This paper explores how gender influences Alzheimer’s disease formation and presentation, and how menopause can contribute to increased prevalence of Alzheimer’s among older women. The paper called attention to the discovery that women with the APOE e4 gene are at greater risk of developing Alzheimer’s disease than men with the same gene, though the reason is unknown. Additionally, the paper explored how women retain their verbal memory longer than men, which could help explain why women are diagnosed later than men and why women decline more rapidly after diagnosis.
  • On May 28, 2019, the Wall Street Journal published an educational video about the complexities of the pharmaceutical supply chain. This video explains how the supply chain works and how it can contribute to rising health costs in the United States.
  • Both New York and Massachusetts recently released the findings of their investigations into the business practices of PBMs. These investigations focused on how PBMs contribute to increased spending on prescription medications and how this can negatively impact patient access. New York’s report, released on May 31, 2019, found that the practice of spread pricing has been squeezing millions of dollars out of the state’s Medicaid program – at least $300 million by one estimate. Unfortunately, this report also found that both the New York State Department of Health and the New York State Department of Civil Service lack adequate authority to regulate PBMs. Massachusetts’ report, released on June 5, 2019, similarly found that spread pricing practices are siphoning money out of the state’s Medicaid program. This report studied the differences in payment policies between fee-for-service Medicaid programs and Medicaid managed care organizations and found that spread pricing is abundant in managed care, but outright prohibited in fee-for-service. The report concluded that, due to these differences and an overall lack of transparency, managed care payers have difficulty determining the value of their drug spending and how their payments are distributed.
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