On August 16, 2022, President Biden signed into law the Inflation Reduction Act (IRA) of 2022, which includes expansive health and climate provisions (Center for Medicare Advocacy 2022). Although this Editorial discusses the IRA, it will focus on the health provisions only. Many issues can change between the writing of this Editorial and its publication, but here are some nuances of the law that case managers can watch. Of course, the first thing to look at in your patients is whether they have a Medicare Advantage Plan or the traditional Fee-for-Service plan. Always stay enlightened with these two very different coverage options.
Some of what the IRA will provide include (Center for Medicare Advocacy 2022):
* Allow Medicare to negotiate with drug manufacturers for the price of some Part D and Part B drugs (starting in 2026);
* Cap beneficiary out-of-pocket Part D drugs costs at $2,000 per year (starting in 2025; in 2024, the 5% coinsurance for Part D catastrophic coverage will be eliminated);
* Impose checks on the annual rise in costs of drugs and Part D premiums (limitations on drug prices start in 2023, and limitations on Part D premiums start in 2024);
* Limit monthly out-of-pocket copays for insulin to $35 (starting in 2023); and
* Expand access to the Part D low-income subsidy ("Extra Help") (starting in 2024).
One important issue for case managers to be aware of are the date/years these provision will start for the beneficiaries; they are not all immediate. The following implementation timeline of the prescription drug-related provisions of the IRA is reproduced from materials from the Kaiser Family Foundation (KFF, 2022):
Certain categories of drugs are excluded from the negotiation process, including (Cubanski et al., 2022):
* Drugs that have a generic or biosimilar available
* Drugs that are less than 9 years (for small-molecule drugs) or 13 years (for biological products) from their Food and Drug Administration (FDA)-approval or licensure date
* "Small biotech drugs" (until 2029), defined as those which account for 1% or less of Part D or Part B spending and account for 80% or more of spending under each part on that manufacturer's drugs
* Drugs with Medicare spending of less than $200 million in 2021 (increased by the Consumer Price Index For All Urban Consumers [CPI-U] for subsequent years)
* Drugs with an orphan designation as their only FDA-approved indication
* All plasma-derived products. The legislation also delays selection of biologic drugs for negotiation by up to 2 years if a biosimilar product is likely to enter the market in that time.
Note that even with the expected $2,000 annually on drugs, this does not prevent increases in the Medicare Part B premium. As always, the devil is in the details.
In addition, other coverage gaps may be allowed (Center for Medicare Advocacy 2022):
Dental health services: While broad coverage for dental services has not been expanded to all Medicare beneficiaries, the Centers for Medicare & Medicaid Services recently issued a proposed rule that includes a proposal to broaden reimbursement for "medically necessary dental services." What "medically necessary services" means is always one for case managers to carefully watch.
Hearing aids: Although this is not currently "law," there has been positive movement on hearing coverage. On August 16, 2022, the FDA announced a final rule that will soon lead to the availability of over-the-counter hearing aids. The rule will create a new category of hearing aids that supersede state-level regulations requiring patients to visit physicians or audiologists to get prescriptions and fittings.
The takeaway is that case managers should monitor this situation, stay alert for nuances, and advocate for your clients/patients. We know that if the changes are confusing to us, they will likely be confusing to our clients/patients.
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