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Aimed Monthly, Volume 1, Issue 7

Welcome to Volume 1, Issue 7 of Aimed Monthly! In this issue, we have several updates we’re excited to share with you, including progress on copay accumulators, our recent comment to the U.S. Food and Drug Administration (FDA) regarding regulation of products containing cannabidiol (CBD), and updates regarding federal regulations that we have been tracking. Start reading below!

Highlights

Department of Labor - Copay Accumulators
While three states have passed laws limiting the use of copay accumulator policies in commercial health plans, these laws do not apply to employer-sponsored health plans. Aimed Alliance has urged Congressional leaders to amend the Employee Retirement Income Security Act (ERISA) to create uniformity across every type of health plan, and we have also asked the Department of Labor to issue guidance that clarifies how the implementation of a copay accumulator policy in an employer-sponsored health plan could violate fiduciary duties. For instance, if an employer-sponsored plan using language that is intentionally misleading to describe a copay accumulator policy, such action could violate the fiduciary duty not to mislead plan enrollees. The Department of Labor has responded to our request and has indicated that it is cognizant of this issue and exploring ways to address it. To review the current status of copay accumulator programs, review our recent work on the issue.
CBD Comment
On May 31, 2019, the FDA held a hearing where it sought information from the public regarding the safety, manufacturing, quality, marketing, labeling, and sale of products containing cannabis and cannabis-derived compounds. This hearing was the federal government’s most recent attempt to grapple with the complexities of regulating the many types of products that contain cannabis. This hearing follows the federal government exempting hemp from the Controlled Substances Act, which allows consumers to acquire hemp-derived CBD products without a prescription. Aimed Alliance submitted a comment to the FDA with recommendations to improve health and safety risks and to reduce consumer confusion regarding food and supplement products containing CBD.  Read our comment and view our infographic to learn more about this issue and our position on it.
EPIC Brochures 
Following the launch of the Exocrine Pancreatic Insufficiency Coalition (EPIC), Aimed Alliance published several Know Your Rights brochures that are tailored towards cystic fibrosis and chronic pancreatitis, which are conditions that are associated with exocrine pancreatic insufficiency (EPI). We also published a brochure specific to EPI. There brochures can be found on the EPIC page on the Aimed Alliance website. We have also updated the coalition page to display coalition members’ logos.
Signing On 
During the month of June, Aimed Alliance joined several sign-on letters from other organizations. On June 6, 2019, Aimed Alliance signed onto a letter sent by the MapRx coalition to the House Energy and Commerce and Ways and Means Committees requesting that it implement an out-of-pocket cap for Medicare Part D beneficiaries, as well as providing other recommendations for how to improve the Part D program. On June 10, 2019, Aimed Alliance signed onto a letter sent by the Partnership to Improve Patient Care to the Institute for Clinical and Economic Review (ICER), requesting that the organization do more to incorporate feedback from patients and patient advocates into value assessment frameworks. On June 26, 2019, Aimed Alliance signed onto a letter sent by the All Copays Count coalition to each state’s insurance commissioner, requesting that he or she implement and enforce the new federal rules regarding copay accumulator programs in commercial health insurance policies.
Rebate Rule Reconsidered 
On July 10, 2019, the Trump Administration announced that the rebate rule, proposed in January, will not be finalized due to predictions that it would raise premiums in Medicare, in addition to the estimated $177 billion that the rule would cost the federal government over the next ten years. The proposed rule would have adjusted the Anti-Kickback Statute’s safe harbor provisions to encourage Medicare Part D plans to pass through rebates from pharmaceutical manufacturers to beneficiaries at the point-of-sale. The rule was intended to ensure that patients are able to benefit from pharmaceutical rebates that are negotiated on their behalf by their insurance plan, instead of the plan retaining those rebates and using them to lower aggregate premiums across the plan. Aimed Alliance had supported the rule because it had the potential to reduce pharmaceutical prices and it could have increased access to medically necessary treatments, so we are disappointed to see that it has been abandoned.

Events

  • Migraine Webinar
    • On Tuesday, July 30, 2019, Aimed Alliance will be jointly hosting a webinar with the Headache and Migraine Policy Forum, the Migraine at Work Coalition, and HR.com from 3:00pm to 4:00pm EDT. The webinar is titled “Preventing Discrimination and Providing Quality Benefits for Employees with Migraine Disease and Other Chronic Conditions,” and will feature a patient, an attorney, and a disability and productivity consultant in examining the workplace burdens of migraine disease and how employers can create a positive workplace for employees. The webinar is FREE to attend.
  • Copay Accumulators
    • On Tuesday, August 13, 2019, Aimed Alliance Counsel Stacey L. Worthy, Esq. will be speaking on a panel at CBI’s 2019 Reimbursement and Access Conference, where she will discuss copay accumulator policies. On Wednesday, October 2, 2019, Aimed Alliance Staff Attorney John A. Wylam, Esq. will be joining Carl Schmid from the AIDS Institute and Anna Hyde from the Arthritis Foundation to deliver a panel presentation on copay accumulator programs at CBI’s Coupon and Copay Conference in Philadelphia, PA.

Where We've Been

  • Networking Luncheon
    • On June 28, 2019, Aimed Alliance hosted a networking luncheon for entry- and mid-level health policy professionals. This one-hour meeting served as an introduction to the work of Aimed Alliance and prompted attendees to explore ways that they can collaborate on common issues. This meeting was attended by representatives from the AIDS Institute, the American Cancer Society Cancer Action Network, the National Multiple Sclerosis Society, and the Society for Women’s Health Research.
  • CBD Op-ed
    • Aimed Alliance Counsel Stacey L. Worthy authored an op-ed discussing the need for regulation and oversight of hemp-derived CBD products. The op-ed was published by Natural Products Insider, and focused on the need for stronger manufacturing and testing standards to ensure that products are uniform and unadulterated.

Legislative Update

  • Pennsylvania Waiver
    • On June 11, 2019, Pennsylvania legislators advanced a plan that would move the state off the federally facilitated health insurance exchange platform in favor of the state operating its own digital infrastructure. Lawmakers anticipate that this will save the state several millions of dollars, which they plan to dedicate towards a state reinsurance fund. In light of recent court challenges to the Affordable Care Act, other states that currently rely on the federal marketplace exchange should consider doing the same.
  • New York Nonmedical Switching
    • On June 19, 2019, the New York legislature passed a nonmedical switching bill and sent it to the Governor for his signature. This legislation would protect consumers by restricting the ability of health plans to make changes to their formularies in the middle of the plan year.
  • Illinois Copay Accumulator 
    • On June 27, 2019, the Illinois legislature passed a copay accumulator bill and sent it to the Governor for his signature. This legislation would protect consumers by requiring health plans to count third-party financial assistance towards an enrollee’s deductible, cost-sharing responsibilities, and maximum out-of-pocket costs. If Governor Pritzker signs this into law, Illinois will become the fourth state in the nation to regulate copay accumulator programs.

In Case You Missed It

  • DTC Proposal Struck Down
    • In June 2019, three pharmaceutical manufacturers filed suit against the Trump Administration to challenge a rule that would have required drug pricing information to be included in direct-to-consumer (DTC) advertisements. The manufacturers alleged that the proposed rule encroaches on their First Amendment rights to free speech. On July 8, 2019, Judge Amit Mehta of the D.C. District Court struck down the rule, holding that the U.S. Department of Health and Human Services exceeded its authority. Aimed Alliance had previously submitted comments arguing that drug pricing in DTC ads could cause consumer confusion given that prices will vary significantly depending on health plan coverage. As an alternative, we have recommended implementing drug pricing information based on health coverage into electronic medical record systems instead so that providers could give accurate information to patients.
  • NEJM Work Requirements Study
    • On June 19, 2019, researchers published a study  in the New England Journal of Medicine that explored the relationship between employment rates, insurance coverage, and the recent Medicaid work requirements that were implemented in Arkansas. The study found that the work requirements policy did not lead to gains in employment, which was a rationale used by proponents to support implementing the policy. This study provides one more reason that states that have implemented or are considering implementing a work requirement should rethink such a requirement.
  • Senate HELP Committee Passes LHCCA
    • On June 26, 2019, the Senate’s Health, Education, Labor & Pensions (HELP) Committee passed the Lower Health Care Costs Act of 2019 by a 20-3 bipartisan vote. This legislation contains several provisions that are responsive to our policy priorities, including surprise out-of-network medical bills and anticompetitive terms in pharmacy benefit manager contracts. Following the committee vote, the legislation will advance to a full floor vote in the Senate. To view our comments on the legislation, read our letter.
  • SWHR Toolkit
    • On July 8, 2019, the Society for Women’s Health Research (SWHR) launched a toolkit with easy-to-understand patient information on migraine diagnosis and treatment, including tips on how to navigate treatment options with providers and insurance companies. All information in the toolkit has been vetted by SWHR’s diverse network of researchers, clinicians, and patients to help migraine patients manage their condition and to educate stakeholders about the societal burden of migraine.
Contact Us
Questions, comments, suggestions, or feedback? Send us an email.
Copyright © 2019 Aimed Alliance, All rights reserved.


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