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Aimed Monthly, Volume 2, Issue 12

Happy holidays from the Aimed Alliance team, and welcome to Volume 2, Issue 12 of Aimed Monthly. This month’s issue includes the latest advocacy and regulatory developments regarding nonmedical switching, copay accumulator programs, surprise billing, and consumer protection issues.

Highlights

Aimed Alliance Has New Contact Information

Please be informed that some of our contact information has recently changed. We can now be reached by phone at (202) 349-4089. Additionally, our physical and mailing address is now 1455 Pennsylvania Avenue, NW, Suite 400, Washington, DC 20004. We can always be reached at policy@aimedalliance.org, so please don’t hesitate to reach out with any questions or concerns.
Aimed Alliance Calls on CVS to Preserve Medication Access for Patients with Depression

On January 1, CVS Caremark will update its formulary, dropping coverage of four critical selective serotonin reuptake inhibitor (SSRI) medications, endangering treatment access for patients with depression. Studies have shown that each subsequent switch from one SSRI to another tends to produce less favorable outcomes and increase the risk of treatment-resistant depression. Patients who are forced to switch their medication for non-medical reasons may experience negative side effects, including increased depression symptoms, risks of suicide, nausea, dizziness, sensory disturbances, and even death. If the new medication is ineffective, patients face a higher risk of relapse and suicide. To address these concerns, Aimed Alliance has taken a number of steps, including the following:
  • Sign-on Letter: On November 23, 2020, Aimed Alliance and 10 other patient advocacy groups wrote a letter calling on CVS to protect stable patients from these switches. Read our letter here.
  • Letter forms: Patients and patient advocates can act now by sending letters directly to CVS, calling on them to protect stable patients with depression. Aimed Alliance’s letter form can be found here, which will be sent directly to CVS’s chief medical officers.
  • Op-ed: On December 24, 2020, RealClearHealth published an op-ed by Aimed Alliance counsel Stacey Worthy on this issue. The op-ed can be found here.
  • Video: Watch Aimed Alliance’s new video to CVS asking it not to leave patients with depression in the dark during the pandemic.
Aimed Alliance Submits a Comment on the NBPP 2022

On December 30, 2020, Aimed Alliance submitted a comment to the Centers for Medicare and Medicaid Serviced (CMS) on its “HHS Notice of Benefit and Payment Parameters for 2022” (NBPP 2022). The comment urged CMS to reinstate limitations on the use of copay accumulator programs as set forth in the NBPP 2020. The NBPP 2020 limited the use of copay accumulator programs to instances in which both a brand and generic medication were available. It incentivized cost savings by steering patients to generic medications when available, but it also recognized that copay accumulator programs are inappropriate when there is no generic alternative. The NBPP 2021 revoked those protections, and the NBPP 2022 is silent on this issue. Given the significant increase in plans adopting a copay accumulator program under NBPP 2021 and the ongoing COVID-19 pandemic, the comment urges CMS to reinstate the NBPP 2020 protections as they relate to copay accumulator programs.
Aimed Alliance Submits a Comment to the NY Department of Health Regarding Safe CBD Consumption

On December 23, 2020, Aimed Alliance submitted a comment to the New York Department of Health on a proposed rule to regulate cannabidiol (CBD) products sold in the state. Aimed Alliance expressed concern that the proposed rule allows high concentrations of CBD in food and dietary supplement products (up to 25mg per food product and up to 3,000mg per dietary supplement) despite the U.S. Food and Drug Administration (FDA) stating that CBD food and dietary supplement products are currently illegal. At this time, there is no regulatory pathway for such products to ensure that they are both safe and effective. High concentrations of CBD could result in harm to some consumers, as the effects of CBD in high doses and in special populations remain unclear. States should wait for FDA guidance on appropriate concentration levels before allowing CBD products to reach consumers. Read the full proposed rule here and our comment here.
CMS Releases Final Rule on Medicaid Value-Based Purchasing Arrangements with Copay Accumulator Program Implications

On December 21, 2020, CMS finalized a rule to alter the method by which “Medicaid best price” is calculated. In particular, the rule finalizes a controversial change requiring the value of copay assistance that drug makers provide to patients to be subtracted from best price calculations if a health plan implements a copay accumulator program. Previous regulations allowed for manufacturer copay assistance to be excluded from the Medicaid best price to the extent that the assistance benefits are provided entirely to the patient. CMS’s rational for the rule was that the full value of the financial assistance does not reach the patient. However, given the lack of transparency around copay accumulator programs, drug makers often do not know when a health plan has implemented such a program. As a result, subtracting the value of financial assistance from Medicaid drug pricing may disincentivize manufacturers from providing such financial assistance to vulnerable patients.

This rule is set to take effect on January 1, 2023. The delay may allow for time to come up with a solution for patients, which would ideally be to limit the use of copay accumulator programs. The final rule, which will be published on December 31, 2020, can be read here.

Legislative Update


Federal Surprise Billing Law
 
The new stimulus package signed into law on December 28, 2030 included the No Surprises Act, which establishes protections for patients against the practice of “surprise billing.” Surprise billing is a term for unanticipated bills that individuals receive after they have sought care at an in-network medical facility but were unknowingly treated by an out-of-network provider. Under the new law, which takes effect starting in 2022, individuals are not to receive any surprise bills when they receive emergency care, are transported by an air ambulance, or receive nonemergency care at an in-network hospital but are unknowingly treated by an out-of-network practitioner or laboratory. Under these circumstances, individuals will only pay the in-network deductible and copayment amounts under terms of their insurance plans. The bill requires hospitals and medical providers negotiate acceptable payments with insurers and not hold the patients responsible for the difference between in-network and out-of-network costs. For individuals without insurance, the bill requires the Department of Health and Human Services to create a bill dispute resolution process between providers and patients.
 
In non-emergency situations, if patients proactively choose to seek medical care from out-of-network providers, the bill requires those providers to offer a cost estimate and get patient consent at least 72 hours before treatment or the day of appointment in certain circumstances.  
 
Texas Prior Authorization Bill
 
On December 23, 2020, Texas introduced a new bill that prohibits health plans from requiring prior authorization for any drugs prescribed to treat a chronic or autoimmune disease.

Events

  • On January 14, 2021, Aimed Alliance will host a webinar titled “The State of Migraine Disease in the Workplace” with HR.com. During this webinar, we will release the results from our upcoming report of the same name, which explores how employers perceive migraine disease, provide accommodations, and incorporate practices to help improve the chances of success. We will be joined by Wendy Bohmfalk, Director of Operations at the World Health Education Foundation, and Brian Gifford, Director of Research and Analytics at Integrated Benefits Institute. Register for the event here.

Where We've Been

In Case You Missed It

Supreme Court Ruling Opens Door to State Regulations of PBMs
 
On December 10, 2020, the Supreme Court of the United States held that Arkansas Act 900 is not preempted by ERISA, opening the door to state regulations of pharmacy benefit managers (PBMs). The Arkansas law requires PBMs to reimburse pharmacies no less than what pharmacies pay for generic drugs and was adopted due to concerns that PBM reimbursement rates are often lower than pharmacy costs. Although the Court found ERISA preempted state laws in two recent cases (Aetna Health v. Davilia in 2004; Gobeille v. Liberty Mutual in 2016), the Court found the Arkansas law does not relate to plans covered by ERISA because Act 900 does not regulate the structure of benefits or require coverage of specific benefits. Justice Sotomayor noted that “ERISA does not preempt state rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage.” Read the full opinion, captioned Rutledge v. Pharm. Care Mgmt. Assn.here.
 
CMS Unveils Rule to Streamline and Speed Up Prior Authorization Decisions
 
On December 10, 2020, CMS proposed a new rule aimed at reducing the time payers take to issue a prior authorization decision and increasing payer data sharing to ease patient transfer between payers. Among other things, it requires Medicaid, CHIP, and Qualified Health Plan payers to issue decisions on prior authorizations within 72 hours for urgent requests and seven days for non-urgent requests, and payers must include a specific reason when denying a prior authorization request. This data must be publicly reported, including average wait times from submission to determination and the percentage of prior authorization requests approved, denied, and approved after appeal. The proposed rule also requires payers to share claims and encounter data with other payers to allow efficient information flow, allowing patients to take their health information with them when changing plans. CMS is accepting comments before 5:00pm EST on January 4, 2021. Read the full proposed rule here.

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