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Aimed Monthly, Volume 3, Issue 2

Welcome to Volume 3, Issue 2 of Aimed Monthly. This month’s issue includes the latest advocacy and regulatory developments regarding copay accumulator programs, prior authorization requirements, and nonmedical switching; and our report on migraine disease in the workplace.


Aimed Alliance Submits Letters to State Legislators Advocating for Bills Limiting Copay Accumulators

Aimed Alliance submitted letters to legislators advocating for limits on copay accumulator programs in 10 states: Maryland, New Mexico, Connecticut, Kentucky, New York, Nebraska, South Dakota, Oregon, Ohio, and Tennessee. These programs prevent third party assistance to patients, such as drug manufacturer’s coupons, from counting toward a patient’s deductible and maximum out-of-pocket limit. This can result in significant financial harm to patients, and patients may be forced to ration their medications or abandon treatment altogether. Aimed Alliance advocated for bills that require payers to include any payments made by the insured or on behalf of the insured when calculating the cost-sharing requirement and maximum out-of-pocket limit. These bills are particularly important during the COVID-19 pandemic, due to elevated unemployment levels and an increased reliance on marketplace exchange plans with high out-of-pocket costs.
Aimed Alliance Asks CMS and HHS to Freeze NBPP 2022 and Reinstate Limitations on Copay Accumulator Programs

Aimed Alliance sent a letter to the Department for Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) asking the agencies to take the following actions regarding the Notice of Benefit and Payment Parameters for 2022 (NBPP 2022):
  • Freeze the NBPP 2022 for 60 days;
  • Open a 30-day comment period for the NBPP 2022; and
  • In its review of NBPP 2022, reinstate NBPP 2020 protections governing the use of copay accumulator programs.
In our letter, we assert that CMS violated the Administrative Procedure Act, which requires the agency to consider and address significant comments on a particular relevant matter presented. While at least 20 comments asked CMS to reconsider reinstating copay accumulator limitations from the NBPP 2020, CMS failed to address those comments in the final rule. Read our letter here.
Aimed Alliance Asks HHS and CMS to Freeze and Revoke Recent Changes to the Medicaid Best Price Rule 

Aimed Alliance submitted a letter requesting CMS to freeze and revise a recently passed rule on Medicaid Value-Based Purchasing. The rule, which is scheduled to go into effect on March 1, 2021, would require copay assistance to be counted toward the calculation of a prescription medication’s best price if a health plan has implemented a copay accumulator program. This would disincentivize drug manufacturers from providing copay assistance to vulnerable patients who may not be able to afford medically necessary treatments. This limit on copay assistance would be compounded with the medical and financial difficulties imposed on patients by copay accumulator programs, which increase financial strain on patients and can lead to decreased medication adherence. Aimed Alliance argues that under the current rule, manufacturers would be unable to determine if a health plan has adopted a copay accumulator program for a particular medication and would likely abandon offering any copay assistance. As such, Aimed Alliance argues that CMS should either reverse these changes or prohibit health plans from implementing copay accumulator programs altogether, as CMS has explicitly acknowledged the harm these programs may have on patients. Read our letter here.
Aimed Alliance Infographic Identifies Best Practices for Migraine Management in the Workplace 

A new Aimed Alliance infographic demonstrates ongoing challenges employees with migraine disease face in the workplace and best practices employers can take to improve chances of success. The survey summarizes the findings of our recent study, “Migraine Disease in the Workplace 2021.” For example, about 60% of HR professionals recognize that migraine disease can be considered a disability in their organization, but many managers and HR professionals lack knowledge about the disease. Furthermore, 40% of participants said their direct supervisors believe employees with migraine disease are “faking it” or “exaggerating,” and that migraine management is not a valid reason for missing work. Only 56% of respondents agreed their organization was doing a good job accommodating employees with migraine disease. Many reported their organization failed to provide common accommodations like alternative lighting, providing health insurance plans without restrictions like prior authorization for migraine disease, or implementing support like migraine training and education for the employer and employees. The infographic identifies what leaders in the migraine management field have done, including providing health insurance that covers migraine disease, creating training programs about migraine disease stigma and legal protections, and reviewing the organization’s culture and wellness plans to ensure they provide the necessary support. Read the infographic here and the survey report here.

Legislative Update

  • AZ SB1270: Would establish certain minimum clinical review standards for health care insurers, pharmacy benefit managers, and utilization review organizations that establish step therapy protocols. Additionally, it would establish a step therapy exception determination process, and require that an exception request be granted if sufficient evidence is submitted. For example, an exception must be granted if the requesting provider can show that the drug being required is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.
  • GA SB80: The “Ensuring Transparency in Prior Authorization Act” contains several different provisions related to implementing prior authorization requirements. For example, it would require insurers to (1) publish on their websites for health care providers any current prior authorization requirements or restrictions; (2) update such website prior to implementing any new requirements or making changes to existing prior authorization requirements; and (3) ensure that all adverse coverage determinations are made by an appropriately credentialed health care provider who practices in the specialty as the provider involved in the prior authorization request. The bill additionally would set forth certain procedural requirements for utilization review entities, including notice requirements related to medical necessity determinations, appeal reviews, and determinations for urgent health care services, among other things. Further, prior authorization would not be required for unanticipated covered health care services which are incidental to the primary covered health care services and determined by the covered person’s provider to be medically necessary. Finally, if there is a change in coverage of, or approval criteria for, a previously authorized health care service, the change in coverage or approval criteria would not affect a covered person who received prior authorization before the effective date of such change for the remainder of the covered person’s plan year so long as such covered person remains covered by the same insurer. 
  • NY S04111: Would prohibit health care plans that provide essential benefits under the Affordable Care Act from removing a prescription drug from a formulary or adding new or additional formulary restrictions from a formulary during an enrollment year. The bill would also require notice to policyholders of the intent to remove a prescription drug from a formulary or alter deductible, copayments coinsurance requirements in the upcoming plan year, thirty days prior to the open enrollment period for the consecutive plan year.
  • NY AB A4123: Would require Medicaid managed care plans to adopt the procedural protections of the Preferred Drug Program, which is a New York State Medicaid program that promotes the use of less expensive prescription drugs when medically appropriate. The procedural protections include “prescriber prevails” for all drugs. Under “prescriber prevails,” prior authorization for a non-preferred drug will be granted if a prescriber shows that the patient meets certain criteria, or if the prescriber can provide additional information to reasonably justify the use of the non-preferred drug.

Media Coverage

In Case You Missed It

CMS Starts Process to Rescind Medicaid Work Requirements
CMS notified states that it no longer believes work requirements are compatible with the goals of Medicaid and is giving states 30 days to argue in favor of keeping the programs. The work requirement demonstrations, created under the Trump administration, would allow states to revoke Medicaid coverage when a beneficiary fails to seek or obtain a job. These requirements have been subject to numerous court challenges since their creation. CMS argues that with the ongoing pandemic and increasing health inequalities, the impact of work requirements could be detrimental to vulnerable populations, and that Medicaid coverage should be based on need, not the ability to find work. CMS is also considering keeping some portions of the demonstration projects, like the extension of Medicaid eligibility to certain otherwise-ineligible individuals, and is only looking to revoke the work requirements. Read more here.

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