In 2023, the FDA authorised the primary over the counter (OTC) daily oral contraceptive pill, Opill, and extra just lately, the primary OTC at-home test for chlamydia and gonorrhea, Easy 2 Check. With those OTC merchandise turning into to be had on-line and/or in retail outlets quickly, the implementation problems raised concerning the availability and affordability of those merchandise and different OTC preventive provides have garnered the eye of policymakers and advocates. Personal insurers and Medicaid typically require a prescription to hide OTC merchandise, so although those merchandise will likely be to be had with out the wish to download a prescription from a clinician, protection with no prescription will likely be restricted with out federal or state motion.
In October 2023, the Departments of the Treasury, Exertions, and Well being and Human Products and services issued a request for information to assemble public enter in regards to the possible advantages, prices, and implementation concerns of requiring personal medical insurance plans to hide OTC preventive products and services and provides with no prescription.
This coverage watch addresses key concerns for the implementation of insurance plans for non-prescribed OTC contraceptives in accordance with the teachings realized from KFF’s 2023 study of Insurance Coverage of OTC Oral Contraceptives. KFF body of workers interviewed greater than 80 folks representing key avid gamers in states that require state regulated plans to hide sure OTC birth control strategies with no prescription and without spending a dime sharing.
Present federal coverage does no longer require insurance plans of OTC contraceptives with no prescription (not like the ACA contraceptive protection necessities that mandate protection with out a affected person cost-sharing with a prescription). Thus far, then again, six states have handed rules requiring state-regulated personal well being plans to hide sure OTC birth control, similar to emergency birth control and condoms, with out the desire for a prescription and with out cost-sharing (Determine 1). State medical insurance necessities follow to particular person plans, plans introduced by way of public employers, and fully-insured plans introduced by way of personal employers, however to not self-funded plans introduced by way of personal employers, which duvet nearly two-thirds of employees with employer-sponsored insurance coverage. Seven states use state-only budget to offer protection for sure non-prescribed OTC contraceptives for Medicaid beneficiaries. In different states, well being plans hardly be offering this protection to their enrollees voluntarily.
Billing Protocols for OTC Contraceptives in States that Require Protection
In states the place protection for OTC birth control is needed with no prescription, there are typically two pathways for shoppers to obtain protection.
- Direct billing on the pharmacy counter: That is probably the most repeatedly used billing means and calls for shoppers to procure the product on the pharmacy counter. Relying at the insurer’s protocol, the pharmacist or technician should input a Nationwide Supplier Identifier (NPI), a novel, 10-digit quantity issued by way of the Facilities for Medicare and Medicaid Products and services (CMS) to well being care suppliers, together with pharmacists, which may be used for billing functions. This declare is then transmitted to the plan, the drugstore is reimbursed, and the policyholder receives the product in a lot the similar approach that almost all prescription drugs are processed.
- Buying the OTC contraceptive product out of doors the drugstore, with the enrollee filing a pharmacy declare to the plan: This system of protection is utilized by few personal well being plans and is very similar to the repayment procedure that was once used for some at-home COVID-19 checks. Whilst this feature can enlarge get right of entry to to protection in sure scenarios, it doubtlessly poses monetary and logistical limitations for the enrollee since the policyholder must pay the price prematurely and navigate the plan’s claims and repayment procedure.
Issues for Imposing Protection of OTC Birth control
On the whole, maximum personal insurance coverage and Medicaid cost programs had been set as much as procedure claims for prescription drugs and lately lack the infrastructure to procedure claims for non-prescribed OTC medication. Key avid gamers interviewed by way of KFF cited several common implementation challenges and possible approaches, together with:
- Setting up common NPI numbers for OTC merchandise and standardized billing protocols: Interviewees famous that billing protocols for non-prescribed OTC birth control range broadly by way of medical insurance plan, resulting in confusion for some pharmacists. Some states that experience applied protection of OTC contraceptives with no prescription for his or her Medicaid enrollees have created a common NPI quantity for each and every coated OTC contraceptive to steer clear of the wish to for pharmacists or pharmacies to go into their particular person NPI numbers for an OTC product. In interviews with pharmacists, some mentioned they have been reluctant to go into their very own NPI quantity for a product they didn’t prescribe, mentioning considerations about possible criminal legal responsibility. A standardized billing procedure throughout payors would facilitate any federal or state requirement to hide OTC medication.
- Expanding consciousness and communique: There was little explicit outreach about this coated get advantages to well being plan enrollees and pharmacists, and there was restricted communique about billing protocols between pharmacies, pharmacy get advantages managers (PBMs), well being plans, and state insurance coverage departments. Expanding consciousness and bettering communique throughout key avid gamers can assist building up usage of this coated get advantages and facilitate protection for OTC contraceptives.
- Mitigating pharmacist and pharmacy body of workers overload: The role and scope of pharmacists and pharmacy body of workers in well being care have unexpectedly expanded over time, with a rising choice of pharmacists shelling out medicine, administering vaccines, and counseling sufferers, amongst different products and services. Group of workers at primary drugstore chains just lately staged walkouts over tough operating stipulations. Processing claims for OTC contraceptives provides every other layer of accountability for pharmacists who’re already overstretched. Correctly assessing pharmacy staffing wishes, compensating pharmacists for the time it takes to procedure those claims, and streamlining the billing procedure have been known as elements that might alleviate those demanding situations and permit pharmacists and different body of workers to play a job in facilitating protection of OTC contraceptives.
Protection for non-prescribed preventive well being care pieces to be had over-the-counter may facilitate get right of entry to to a vast vary of OTC merchandise that fortify sexual and reproductive well being, together with emergency contraceptive pills; condoms; folic acid dietary supplements; and the newly-FDA-approved STI tests, and pave the best way for brand new contraceptive merchandise that can change into FDA authorised for OTC use one day.
Around the spectrum of key avid gamers, the KFF analysis finds that there’s passion and engagement about the opportunity of OTC birth control to expand the provision of and get right of entry to to contraceptive choices, however the extent to which this happens depends on many elements, together with state and federal insurance policies and steering, pharmacy engagement, billing programs, and public and supplier consciousness, and adjustments to present programs of protection.
Further KFF sources on Over-The-Counter Contraceptive Tablets: