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Aimed Monthly, Volume 1, Issue 10

Welcome to Volume 1, Issue 10 of Aimed Monthly! In this issue, we are highlighting a petition for rulemaking that we recently sent to three federal agencies requesting regulatory action on copay accumulators, a new open enrollment brochure for Medicare beneficiaries, a new partnership with the Hawaii-based Atherton Family Foundation, an upcoming webinar on copay accumulator programs, and more! Start reading below to see what we have been up to over the past month.


Petition for Rulemaking
On October 9, 2019, Aimed Alliance sent a petition for rulemaking to the U.S. Department of Health and Human Services (HHS), the U.S. Department of Labor (DOL), and the U.S. Department of Treasury, asking them to rescind the FAQs about Affordable Care Act Implement Part 40 (FAQ).
In April, HHS issued the Notice of Benefit and Payment Parameters for 2020 (2020 NBPP), which contains language that arguably prohibits copay accumulator programs unless a patient fills a prescription for a brand drug with a generic equivalent. On August 29, 2019, the Departments issued the FAQ, which declares that HHS will not enforce that part of the 2020 NBPP due to ambiguities around how the rule would be implemented in high deductible health plans (HDHPs) with accompanying health savings accounts (HSAs). On October 9, 2019, Aimed Alliance submitted its petition for rulemaking to the three agencies, requesting that they revoke the FAQ and issue new guidance, clarifying that individuals will not be disqualified from enrolling in an HSA if a HDHP sponsor complies with the 2020 Rule. Read our petition in full.
Medicare Open Enrollment Brochure
Aimed Alliance has published a brochure to assist consumers select a Medicare plan during the open enrollment period. This brochure contains comprehensive information on both traditional Medicare and Medicare Advantage plans and explains the differences between these types of plans. The brochure is intended to help consumers select the plan that is right for them based on the treatments and services they need most. If you or a loved one qualify for Medicare, view our brochure.
Partnership with Atherton Family Foundation, Foundation Funding 
Aimed Alliance recently received funding from the Hawaii-based Atherton Family Foundation to study the Hawaii Medical Service Association’s recent initiative that is changing how primary care providers in the state are compensated. Stay tuned for future updates on this issue.
Supporting Hospital Transparency 
On September 27, 2019, Aimed Alliance submitted a comment to HHS in response to the agency’s proposal to require hospitals to publish additional pricing information. The proposed rule, titled Calendar Year 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule, would allow consumers to make better price comparisons for health services offered by hospitals and health systems. Aimed Alliance supports many of the transparency provisions in the proposed rule but cautions HHS against requiring hospitals to publish certain overly broad information about pricing that could serve to confuse consumers instead of informing them. Review our comment to learn more.
ICER Comments on Cardiovascular Disease and Value Assessment Framework 
On September 26, 2019, Aimed Alliance delivered oral comments on the Institute for Clinical and Economic Review’s (ICER) Evidence Report on Additive Therapies for Cardiovascular Disease: Effectiveness and Value. We thanked ICER for deeming both icosapent ethyl and rivaroxaban to be cost effective and responsibly priced. We also highlighted our concerns that (1) the Evidence Report would impact patient access by encouraging the use of prior authorization and other benefit utilization management policies; (2) ICER did not incorporate several important considerations into its potential budget impact analysis and value-based benchmark prices; and (3) ICER’s use of Quality Adjusted Life Years (QALYs) will result in inappropriate health care rationing and discrimination. ICER’s Final Evidence Report is due out October 17, 2019.
On October 15, 2019, Aimed Alliance submitted a written comment to ICER regarding its Proposed Changes to the 2020 Value Assessment Framework. Aimed Alliance thanked ICER for its stated commitments to the inclusion of real-world evidence and the patient perspective in its Value Assessment Framework, but explained our concern that the Proposed Changes still do not provide adequate mechanisms to ensure the inclusion of real world evidence into its cost-effectiveness assessment, potential budget impact, and value-based benchmark pricing. We also asked ICER to consistently include patients and medical specialists in the therapeutic area under analysis in its Evidence Appraisal Council Membership, and to provide greater transparency about the Evidence Evaluated through the Value Assessment Framework. Finally, the comment called on ICER to not use QALYs to determine the comparative effectiveness of treatment.


  • Biosimilars
    • On Friday, October 25, 2019, Aimed Alliance Counsel Stacey L. Worthy, Esq. will be speaking at HealthyWomen’s Biosimilars & Women’s Health Forum at the National Union Building in Washington, DC. This event will bring together patient advocates, researchers, and clinicians, and industry and government representatives. Ms. Worthy will be discussing current federal legislation and regulations regarding biosimilars. To register, click here. 
  • Copay Accumulator Webinar
    • Join Aimed Alliance on November 7, 2019 from 12:00-1:00pm ET for a webinar on employers’ use of copay accumulator programs titled Copay Accumulators: Striking a Balance Between Promoting a Healthy Work Force and Managing Costs. This webinar will provide insight into recent legislative and regulatory activity impacting copay accumulator programs, data on the impact that copay accumulator programs have on employees, and recommendations and best practices for employers who are interested in implementing a copay accumulator program in their health benefits. Click here to register. Presenters will include:
      • Stacey L. Worthy, Esq., Aimed Alliance Counsel
      • John A. Wylam, Esq., Aimed Alliance Staff Attorney
      • Rick Fry, TrialCard Vice President of Client Services
      • Bruce Sherman, MD, National Alliance of Healthcare Purchaser Coalitions Chief Medical Officer
  • NFWL
    • Aimed Alliance Counsel Stacey L. Worthy, Esq. will be presenting on emerging health care topics at the National Foundation of Women Legislators’ Annual Conference in San Antonio, TX on November 19, 2019.
  • Lunch-and-Learn Series on Cannabidiol (CBD)
    • Greenwich Biosciences is sponsoring a series of Lunch-and-Learn seminars to serve as a primer on CBD. It is intended to help raise awareness and facilitate an open dialogue around the current and anticipated legislative and regulatory environment around cannabidiol and cannabidiol-based products. Aimed Alliance has heard from many of our collaborators that more information is needed, but it is unclear how best to get started.  
      These lunch-and-learns are designed to level-set around the current environment and provide a comprehensive overview of the available scientific and policy dialogues ongoing in Washington DC. Two were held in October, and the remaining two are scheduled for November 14 and November 15.  Each of the four Lunch-and-Learns have a unique focus to a particular set of stakeholders and co-convened by thought leaders in the space. We encourage you to participate in these events and learn more about the issues. All events will run from 12:00pm – 1:30pm on their respective days. Should there be any questions, please do not hesitate to reach out to Matthew Rubin, who is helping to coordinate these sessions.

In Case You Missed It

  • Nonmedical Switching Op-Ed
    • On October 8, 2019, the Columbus Dispatch published an op-ed authored by Aimed Alliance Staff Attorney John A. Wylam, Esq., which discusses the issue of nonmedical switching among health systems in Ohio. This issue arises when patients are forced to switch medications for nonmedical reasons, which can be harmful to their health
  • Bad Drug Advertisement Brochure
    • We recently published a brochure on “bad drug” advertisements, which often use frightening language and imagery that can dissuade patients from taking their medications. Following the publication of this brochure, we sent a copy of it to Attorneys General across the country to raise awareness about the issue.
  • Growing Health Costs
    • New data from the National Business Group on Health reveals how, in 2019, costs to employers associated with providing health coverage to employees has surpassed $15,000 per year, per employee. This is putting significant pressure on both employees and employers to contain health care costs as they continue to grow.
  • Medicare Part D and PCSK9 Inhibitors
    • PCSK9 inhibitors are an important tool for reducing the risk of heart attack, stroke, and cardiovascular disease by lowering LDL cholesterol. However, access to these medications has been restricted by payers due to their high cost. Fortunately, the Trump Administration recently announced that PCSK9 inhibitors will no longer be on the specialty tier in Medicare Part D, which could increase access to these medications for America’s seniors.
  • New HHS Opioid Prescribing Guidelines
    • On October 10, 2019, HHS issued new guidelines for prescribing opioids for chronic pain. These guidelines provide guardrails for prescribers on when it is appropriate to taper patients off opioids and are intended to allow patients who have a legitimate medical need for medications to continue receiving such treatment.
Contact Us
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