I’ve said all along that it was obvious that only Epidiolex would qualify for Medicare’s new Plan D CBD drug coverage, and now they admit it as well. And when Sativex is approved, Jazz Pharmaceuticals will also have the monopoly on delta-9 THC drugs, like they do now with CBD because Epidiolex and FDA’s drug preclusion policy.
Rush those CBG and Varin medicines to market guys, before they do.
However, it is odd af that they reference FOODS here as though they were drugs, evidently thinking all 25,000 things from hemp were the same things, that your cereal or shirt could be high in D9, CBD, D8, HHC, THC-O, etc.
Did they paint themselves into a corner with a premature announcement which benefited just one company, then grasped at straws to include hempseed instead as a justification?
Crazy times ahead when lunatics run the asylum.
Now Open For Comments:
“Medicare Program: Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
Posted by the Centers for Medicare & Medicaid Services on Nov 28, 2025.
Currently, only one product that meets the definition of hemp under the 2018 Farm Bill has been approved as a drug in the United States: the prescription drug Epidiolex.
CMS notes that Epidiolex has been approved by the FDA to treat seizures and is covered under Medicare Part D, so it would not be permitted to be offered as a Part C supplemental benefit.
In addition, in December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. (38)
FDA had no questions at that time about the notifier’s conclusion that the ingredients were GRAS for their intended use in food. An ingredient that meets the GRAS standard can be used in food without being required to undergo premarket review and approval by FDA for that intended use. (39)
Therefore, this proposal would allow MA organizations to offer hulled hemp seed, hemp seed protein powder, and hemp seed oil, consistent with FDA’s review of the GRAS notices,—as SSBCI to qualifying enrollees, to the extent otherwise appropriate as SSBCI and under federal and applicable state law.
Additionally, at this time, any cannabis product with a delta-9 THC content above the 0.3 percent threshold is still considered marijuana, remains a Schedule I controlled substance, and therefore is illegal under federal law and would be subject to CMS’s prohibition. Any product that does not comply with the amended definition of hemp after the November 12th, 2026, effective date will be a Schedule I controlled substance as of that date, and therefore will be illegal under federal law (40) and subject to CMS’s prohibition.
Section 1852(a)(3)(D)(ii)(I) of the Act requires that an item or service offered as an SSBCI must have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee.
There may be situations in which foods containing one or more of these three specific ingredients meet the “reasonable expectation of improving or maintaining the health or overall function” standard for SSBCI. For example, there is evidence that hemp seed protein powder may offer nutritional benefits. (41) CMS reminds MA organizations about the importance of ensuring that the items and services provided to enrollees, including any foods containing these specific hemp-derived ingredients, meet the requirements for being offered as an SSBCI.
CMS notes that if this proposal is finalized and MA organizations choose to offer any of these three hemp-derived ingredients, they would be subject to all applicable SSBCI requirements under § 422.102(f), including the bibliography requirements for SSBCI items and services set forth at 42 CFR 422.102(f)(3) to demonstrate through relevant acceptable evidence that the item has a reasonable expectation of improving or maintaining the health or overall function of a chronically ill enrollee.”
Read more at: https://www.regulations.gov/document/CMS-2025-1393-0002