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Aimed Monthly, Volume 3, Issue 3

Welcome to Volume 3, Issue 3 of Aimed Monthly. This month’s issue includes the latest advocacy, legislative, and regulatory developments at the federal and state levels, including Aimed Alliance’s step therapy reform initiative in New York, Six Protected Classes demonstration project; the Hospital Price Transparency rule; new copayment accumulator law; and a webcast providing insight to people with migraine disease on navigating in the workplace.


Aimed Alliance Launches New Step Therapy Reform Initiative in New York

In 2020, Aimed Alliance conducted a survey of 213 New York health care professionals that gauged the degree to which health plans are complying with the state’s step therapy law. Key findings included the following:
  • Almost half (44 percent) of survey respondents indicated that health plans are requiring patients to try and fail on a medication that they have already tried “every time” or “most times,” even though the law requires health plans to grant a step therapy exception in these situations.
  • Only about one-third of respondents (32 percent) agree that the step therapy exception process has gotten easier since the law has passed.
  • Nearly half of survey respondents (46 percent) believe that the changes in the law have not led to any significant difference in whether insurers approve exception requests.
Aimed Alliance developed the following fact sheets to educate New York regulators regarding step therapy reform:  
Additionally, Aimed Alliance also created the following educational fact sheets explaining why certain chronic disease states need additional protections. The fact sheets contain real patient stories on the negative impact of step therapy for these conditions:

Legislative & Regulatory Updates

  • CMS Reverses Recent Demonstration Plan That Would Have Allowed Part D Plans to Waive Protected Class and Formulary Requirements in 2022
    • CMS announced updates to the Part D Payment Modernization Model Calendar Year 2022 (PDM Model), reversing changes that were implemented in the final days of the Trump Administration. The PDM Model would have removed important protections for drugs in the six protected classes, such as allowing plans that participate in the model to treat five out of the six protected classes the same as any other Part D drug class and cover only one drug per class instead of two. Therefore, patients on anticonvulsants, immunosuppressants, antidepressants, antipsychotics, and antineoplastics could have faced nonmedical switching if their Part D provider was selected for participation in the model. Nonmedical switching can result in both negative health outcomes for patients and increased spending by plans, as stable patients may require additional treatment if their new medication is not as effective as their previous prescription. By removing the proposed flexibilities, CMS has ensured that patients retain important and long-running protections in their Part D coverage. Read the full summary of changes here.
  •  HHS Postpones SUNSET Rule Due to Significant Burden on FDA and CMS 
    • The U.S. Department of Health and Human Services (HHS) announced that it will postpone the effective date of a recently finalized rule, “Securing Updated and Necessary Statutory Evaluations Timely,” (SUNSET Rule) until March 22, 2022. The SUNSET Rule would have required HHS to assess and review most of its regulations every 10 years to prevent the regulations from automatically expiring. Complying with the rule would have been particularly burdensome for the U.S. Food and Drug Administration, as the agency would have needed to review approximately 95% of its current regulations, thereby diverting resources from COVID-19 pandemic relief efforts, medical product applications, fulfillment of user fee commitments, and other public health issues, such as ongoing inspections and recalls.
    • Additionally, a coalition of health and consumer advocacy organizations filed suit against HHS, calling the rule a “ticking time bomb” that would eliminate thousands of existing public health and safety regulations across the department’s sub-agencies. As such, HHS is choosing to postpone the rule to evaluate legal concerns raised in the pending litigation and also the significant burden on the department in reviewing regulations. Read the update here.
  • Deloitte Finds Compliance with CMS Hospital Price Transparency Rule is Low Overall
    • A recent report from Deloitte found that most hospitals have been slow to comply with the requirements of the CMS Hospital Price Transparency Rule that went into effect on January 1, 2021. The rule requires hospitals to provide a comprehensive file of all their items and services and a display with 300 shoppable services in a consumer-friendly format. Hospital associations recently lost a lawsuit to block the rule and have asked CMS to put off enforcement until the end of the COVID-19 public health emergency. However, Deloitte found that many hospitals already have the information ready to go but are waiting for their competitors to release the documents. Overall, the rule is expected to improve care delivery and create a more consumer-friendly experience. Read more here.
  • Kentucky Governor Beshear Signs New Copay Accumulator Law
    • On March 25, Kentucky Governor Andy Beshear signed SB45 into law. The new law limits how state-regulated insurers can implement copay accumulator programs. Such programs prevent the value of a drug manufacturer’s financial assistance from counting toward a patient’s deductible and maximum out-of-pocket limit. This can have a significant financial impact on patients, especially those who are prescribed medications for which there are no generic alternatives. Financial strain can result in patients rationing their medication or abandoning treatment altogether, potentially contributing to disease progression, relapse, or other adverse events. The new law limits the use of copayment accumulators to instances where there is a generic alternative available, and also allows medical professionals to exercise significant control over the process if they deem the brand drug medically necessary or if the brand drug was obtained through prior authorization, step therapy, or insurer exceptions or appeals. The new law strikes a balance by steering patients toward less costly, medically appropriate generic medications, while recognizing that copay accumulator programs are otherwise inappropriate. Read the new law here.


  • On April 14, Aimed Alliance counsel, Shruti Kulkarni, will participate as a panelist on a webinar hosted by HealthyWomen and CancerCare on the topic of cancer costs. The panelists will aim to raise awareness of both the emotional and financial tolls of cancer. They will also present resources to help people with cancer and their caregivers navigate and understand the options available to support them both emotionally and financially. Click here to register.

Where We've Been

  • Aimed Alliance Counsel, Shruti Kulkarni, participated in a webcast featured by Migraine in the Workplace’s Thriving in the Workplace series. In the webcast, Ms. Kulkarni shares her insight for people with migraine disease on how to navigate in the workplace. Despite the World Health Organization (WHO) finding that migraine disease is the sixth highest cause of disability worldwide, there remains significant stigma and misunderstandings of the disease. People with this disease in the workplace may face significant challenges receiving accommodations under the Americans with Disabilities Act. However, individuals may be able to receive the necessary workplace support by educating their supervisor, asking for accommodations, speaking up (while leaving a paper trail), knowing their rights, managing triggers, and taking advantage of both formal and informal work-place support systems like Family and Medical Leave Act (FMLA) time. View the webcast here.

In Case You Missed It

Federal and State Marketplace Exchanges Extend Special Enrollment Deadlines
Following the enactment of the American Rescue Plan, the federal government and several states have extended special enrollment periods to allow consumers to take advantage of the increased Affordable Care Act tax credits available under the new law. The special enrollment period is open to new and current enrollees alike and the tax credits may significantly reduce premiums for eligible individuals. The federal government will keep open until August 15th. To better align with the federal government’s decision, some states, including Colorado, Pennsylvania, Rhode Island, and Maryland, have already announced extensions until August, while California, New York, and the District of Columbia have extended the enrollment period through the end of the year or the end of the pandemic. Idaho extended its enrollment period through April, and Nevada and Washington are currently considering an extension. Read more here.

Contact Us
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