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Aimed Monthly, Volume 3, Issue 1

Happy New Year, and welcome to Volume 3, Issue 1 of Aimed Monthly. This month’s issue includes the latest advocacy and regulatory developments regarding recent executive orders, the Most Favored Nation Model, Six Protected Classes, a new report on migraine disease in the workplace, prior authorization requirements, copay accumulator programs, and step therapy protocols.


Aimed Alliance Survey: State of Migraine Disease in the Workplace 2021

According to a new survey from Aimed Alliance, in partnership with the HR Research Institute and, there is significant confusion among employers about whether migraine disease is considered a disability and wide variety in the extent to which employers offer both accommodations and appropriate benefits for employees with migraine disease. The survey, “State of Migraine Disease in the Workplace 2021,” polled 309 HR professionals nationwide in virtually every industry to determine how employers perceive migraine disease, provide accommodations, and incorporate practices to help improve the chances of success. Read the survey here.
Aimed Alliance Asks CMS to Reinstate Six Protected Classes Requirements

On January 28, 2021, Aimed Alliance submitted a letter requesting that the Centers for Medicare & Medicaid Services (CMS) reverse recent changes to the Part D Modernization Model for Calendar Year 2022 (PDM Model). Currently, Part D sponsors are required to include on their formularies “all or substantially all drugs” within six categories or classes of drugs (i.e., anticonvulsants, immunosuppressants, antidepressants, antipsychotics, antineoplastics, and antiretrovirals), referred to as the “Six Protected Classes.” Under the PDM Model, participating Part D sponsors will be permitted to treat five of the six protected classes as they would other Part D drug starting in 2022, and the sixth class—antiretrovirals—will also lose its protections starting in 2023. The Six Protected Classes include conditions that often require specialized treatment that is targeted to a patient’s specific needs, and the treatments within these classes are often not interchangeable, meaning that if a stable patient is switched, that patient may not achieve the same success on the new medication. Loss of access to a medication or being switched onto something less effective can result in dangerous side effects for the impacted conditions.
Additionally, these changes were enacted without (1) evaluating and ensuring compliance with scientific evidence and medical standards of practice and (2) public notice and comment, both of which violate the Social Security Act. Public notice and comment are particularly important as previous comments proved effective in preventing past administrations’ efforts to change to the Six Protected Classes. Read our letter here.
Aimed Alliance Submits a Comment to CMS on Most Favored Nation Model

On January 26, 2021, Aimed Alliance submitted a comment asking the new administration to revoke the Most Favored Nation Model (Model) interim final rule. The Model is intended to cap reimbursement for 50 Medicare Part B drugs at the lowest price that drug manufacturers receive in other countries similar to the United States. The Model also changes payments made to health care practitioners who administer Part B drugs. Instead of receiving a percent of the drug price, they would receive a small flat fee. CMS is attempting to implement the Model on a nationwide scale in violation of the Patient Protection and Affordable Care Act and originally had planned to start the Model on January 1, 2021. Two district courts found that CMS had violated the Administrative Procedure Act by attempting to implement the rule without the opportunity for public comment.

Additionally, the Model would likely result in lack of access to medications for Medicare beneficiaries. The Model would force health care practitioners to choose between 1) administering the impacted drugs but taking a financial loss; or 2) no longer providing the impacted medications to their patients. Read our comment here.

Legislative Update

Several states have recently introduced legislation to improve access to care, including step therapy and copay accumulator legislation. Such bills include, but are not limited to:  
Copay Accumulator Programs
  • IA HSB46 requires health plans to include all cost-sharing amounts paid by the insured or need-based payments paid on behalf of the insured in calculating the insured’s cost-sharing requirements. However, the bill excludes cost-sharing amounts paid by or on behalf of the insured for a specialty drug or for a prescription for which an A-rated generic equivalent or interchangeable biological product is available to the insured.
  • CT SB 00034, MD SB 290, NE LB270, and NY A01741 require plans to include any payments made by or on behalf of an insured to be applied when calculating individual’s overall contribution to any out-of-pocket maximum or any cost-sharing requirement.
  • KY HB114 and KY SB45 state that health plans are prohibited from excluding any cost-sharing amounts paid on behalf of an insured from counting to the insured’s cost-sharing requirements. This prohibition does not apply if the prescribed medication has a generic alternative unless:
    • The prescriber determines that the brand prescription drug is medically necessary; or
    • The insured has obtained access to the brand prescription drug through prior authorization, a step therapy protocol, or the insurer’s exceptions and appeals process.
  • NY HB 129 requires pharmacy benefit managers (PBMs) to include any payments made by or on behalf of an insured to be applied when calculating individual’s overall contribution to any out-of-pocket maximum or any cost-sharing requirement.
  • OK HB 2800 requires plans to apply any copay assistance or third-party payments to the insured’s deductible, out-of-pocket maximum, and any cost-sharing requirement if
    • The insured’s medication has no generic equivalent; or
    • A generic equivalent exists but the insured has obtained access to the prescribed medication though (1) prior authorization, or (2) a step therapy protocol, or (3) the exception or appeals process.
  • OK HB 3737 and OK HB 2678 state that copay accumulator policies constitute unfair claim settlement practices is in violation of the state Unfair Claims Settlement Practices Act.
  • OR SB 560 requires health plans to include all amounts paid by the insured or on behalf of the insured, including payments from a patient assistance program, when calculating the insured’s out-of-pocket maximum or other cost-sharing limits.
Pharmacy Benefit Manager Reform
  • HI SB 602 prohibits PBMs from engaging in self-serving or deceptive business practices and unfair methods of competition. It also prohibits PBMs from retaining any portion of spread pricing and from limiting a pharmacist’s ability to provide certain information to patients. The bill also increases PBMs’ annual reporting requirements.
Prior Authorization
  • AZ HB 2621 requires plans to provide health care practitioners with access to a uniform prior authorization request form approved by the state.
  • NY AB 3134 requires plans to provide coverage of a 120-day supply of any prescription medication without prior authorization during a state disaster emergency, and requires pharmacies to dispense the 120-day supply of medication at no cost to a patient in the event such patient’s insurance denies coverage due to lack of prior authorization.
Step Therapy
  • AR SB 99 requires healthcare insurers to base step therapy protocols on appropriate clinical practice guidelines or published peer reviewed data developed by independent experts with knowledge of the condition and additional transparency protections so that patients have access to a fair, transparent, and independent process for requesting a step therapy protocol exception when the patient’s physician deems it appropriate
  • KS HB2157 and NJ A4815 require that step therapy protocols be based on clinical practice guidelines, creates an exception process, and requires the plan to grant an exception if the patient has already failed on the same drug; and mandating a timeline for acting on exception requests.
  • NY A03276 prohibits plans from applying step therapy protocols for medications used for the treatment of mental health conditions.

Media Coverage

Where We've Been

  • On January 14, 2021, Aimed Alliance hosted a webinar through titled “The State of Migraine Disease in the Workplace.” The webinar featured the findings of our recent report by the same title. Wendy Bohmfalk, Director of Operations at the World Health Education Foundation & Migraine World Summit and Campaign Manager at Migraine at Work, shared her story of working with migraine disease, and Brian Gifford, Director of Research and Analytics at the Integrated Benefits Institute, shared research and statistics on improving productivity in the workplace for employees with migraine disease. You can view an archived recording of the webinar here.

In Case You Missed It

Biden Signs Executive Order to Open Exchanges for Three Months
On January 28, 2021, President Biden signed an executive order requesting that the Department of Health and Human Services (HHS) create a special enrollment period in response to the COVID-19 public health emergency. Individuals without health insurance will be able to sign up for a health plan through the federal marketplace exchange. HHS announced that the enrollment period will run from February 15 through May 15, 2021. HHS also noted that state-based marketplaces operating their own platforms have the opportunity to take similar actions within their states. In most states, the open enrollment period ended on December 15, 2020. According to a new Kaiser Family Foundation report, the special enrollment period could result in nearly 9 million uninsured Americans receiving free or subsidized health insurance.
Record Enrollment in Exchange Plans  
Covered California announced nearly 1.6 million people have selected plans since the start of open enrollment, or 200,000 more than during the same period last year, setting a record for the nation’s largest state-run exchange. Covered California’s open enrollment will run through Jan. 31.
Also, Minnesota’s health insurance exchange – MNSure – said last week that more than 122,000 residents signed up for a qualified health plan coverage during open enrollment, or 4% more than last year. MNsure’s open enrollment ended on December 22. Read more here.
Biden Issues Executive Order that Could Roll Back Medicaid Work Requirements
On January 28, 2021, the Biden Administration issued an executive order that instructs HHS and CMS to examine 1) demonstrations and waivers that may reduce coverage under or otherwise undermine the Medicaid program; and 2) policies or practices that may present unnecessary barriers to individuals and families attempting to access Medicaid coverage. In recent years, CMS has granted 1115 waivers to several states, allowing them to impose work requirements for Medicaid beneficiaries. As several courts have determined, these work requirements can undermine the Medicaid program and impose barriers to qualification. The Supreme Court is also set to hear a case about Medicaid work requirements.

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