Currently, copay accumulators are being implemented by insurance companies and Pharmacy Benefit Managers (PBMs), harming patient access. With this payor program, the value of copay assistance cards/coupons issued by manufacturers do not count towards out-of-pocket costs that are applied toward deductibles. The result has caused a cost shift onto consumers and away from employers and payers. Unfortunately, in the proposed rule, the Administration defends the use of copay accumulators.
In contrast, Arizona, Virginia, and West Virginia are leading the state legislative efforts this year to ban copay accumulator programs, although Arizona’s approach to this issue is much more measured.
CMS has stated that its final rule would apply to individual market, small, and large group and self-insured group health plans starting in 2020. The final rule is effective June 25, 2019 which will be sixty days from its April 25, 2019 publication date. There will be no further public comments taken for this rule.
States are currently trending against CMS’ position regarding copay accumulators. If you would like to target your state legislation, Frier Levitt Government Affairs (FLGA) can lobby state legislators to prohibit copay accumulator programs. Contact FLGA today to get started.
Cannabidiol (CBD) products have seemingly flood the market, suddenly springing up in many places. This has lead pharmacies, natural health food stores and other retailers to discuss new strategies to position themselves in the developing market of CBD. However, recent market saturation and uncertain regulatory oversight have caused massive confusion of whether these products are legal or not.
In this recorded webinar, Ron W. Lanton, Esq., Executive Director of Frier Levitt Government Affairs, explores several issues around CBD, including: • CBD vs. THC • An examination of current state and federal CBD and Marijuana policies • A discussion of current administration viewpoints, including the FDA and DEA • Other related business trends
Viewers of this webinar will be able to: • Understand relevant CBD terms • Comprehend the current viewpoints CBD and Marijuana policies and business trends • Pinpoint the relationship of the FDA and DEA on CBD
The FDA has released a new draft guidance document titled, “Rare Diseases: Natural History Studies for Drug Development.” The guidance document impacts pharmacy supply chain stakeholders, especially drug manufacturers and specialty interests.
What Does the Guidance Do?
According to the FDA, the Agency is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. Although knowledge of a disease’s natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases, therefore, natural history information is particularly needed for these diseases.
Why You Should Participate:
If you are supply chain stakeholder looking to diversify your business into biological products or to serve rare disease patients, the trend is pointing towards greater utilization of specialty products. Comments are suggested to ensure that the government has your viewpoint in mind when developing further guidance and proposed rules.