Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

HHS Addresses Drug Manufacturer Coupons on Out-of-Pocket Limits

Client Alert

On May 7, 2020, the US Department of Health and Human Services (“HHS”) announced their Notice of Benefit Parameters for 2021 in which HHS addressed the application of prescription drug manufacturer copay coupons towards a patient’s out-of-pocket limit. Under this guidance, HHS will permit, but not require, plans and insurers to count direct support offered to enrollees by drug manufacturers (i.e., coupons) for specific prescription drugs toward the annual limits on cost-sharing, regardless of whether a generic equivalent is available.

In the Notice of Benefit Parameters for 2020, HHS finalized a proposal that for plan years beginning on or after January 1, 2020, amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to enrollees to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing.[1] HHS received stakeholder feedback indicating confusion on whether plans and issuers are required to count the value of all forms of direct support provided by drug manufacturers, including drug manufacturers' coupons, toward the annual limitation on cost sharing, other than in circumstances in which there is a medically appropriate generic equivalent available, particularly with regard to large group market and self-insured group health plans.

In an effort to alleviate this confusion, HHS is revising the rule to state, “…amounts of direct support offered by drug manufacturers to enrollees for specific prescription drugs towards reducing the cost sharing incurred by an enrollee using any form are not required to be counted toward the annual limitation on cost sharing.”[2] Health insurance issuers and group health plans now have the flexibility to determine whether drug manufacturer direct support to enrollees for specific prescription drugs counts toward the annual limitation on cost sharing.

HHS considered a proposal to interpret the definition of “cost sharing” to exclude expenditures covered by drug manufacturer coupons, but after review of proposal rule feedback and comments, is refusing to adopt this interpretation in this 2021 final rule.

Finally, HHS expects issuers and group health plans to be transparent with enrollees regarding potential out-of-pocket liability and whether the value of direct drug manufacturer support accrues to the annual limitation on cost sharing. HHS is encouraging issuers and group health plans to prominently include this information on websites and in brochures, plan summary documents, and other collateral material that consumers may use to select, plan, and understand their benefits, but this is not a requirement.

Please contact a BMD healthcare attorney if you have any questions regarding this final rule, the application of drug manufacturer coupons on cost sharing, or other general healthcare questions. 


Health Care Providers Take Note: Federal Budget Brings Medicaid and Staffing Rule Changes

The 2025 federal budget introduces significant changes for health care providers and Medicaid recipients, including new cost-sharing requirements, work eligibility mandates, rural health grants, and a pause on minimum staffing rules.

Key Healthcare Provisions in Ohio’s 2026–2027 Budget

Ohio’s newly enacted biennial budget (HB 96) for FY 2026–2027 brings sweeping changes for healthcare providers across the state. The law includes new Medicaid eligibility requirements, reporting mandates, funding directives, and social policy provisions. Several vetoes by Governor DeWine also affect healthcare-related initiatives.

Providers Beware: Court Sides with Insurers in No Surprises Act Arbitration

On June 12, 2025, the Fifth Circuit ruled in favor of Aetna and Kaiser in two lawsuits brought by air ambulance providers challenging how insurers calculated payments under the No Surprises Act’s Independent Dispute Resolution process. The court held that unless there is clear evidence of fraud or serious misconduct, IDR decisions will stand, reinforcing the finality of the arbitration process.

Introducing HB 281: Enforcement of Federal Immigration Laws in Ohio Hospitals

House Bill 281, introduced on May 20, 2025, would require Ohio hospitals to allow law enforcement, including federal immigration agents, to enter facilities and enforce immigration laws. The bill mandates that hospitals comply with information requests and adopt formal policies, raising significant concerns about patient privacy and access to care for immigrant communities.

Parental Consent May Soon Be Required for Minor Mental Health Services in Ohio

HB 172 proposes repealing a provision in Ohio law that allows minors age 14 and older to consent to limited outpatient mental health services without parental involvement. The bill would require parental consent for all such care and remove related language from other sections of the Ohio Revised Code.