Browse Advisory Opinions

Favorable opinion regarding an arrangement pursuant to which a company operationalized and makes financial contributions to a foundation, and the foundation provides grants to families of children receiving a particular type of therapy.

Favorable opinion regarding remuneration to physicians with an ownership interest in a device manufacturer.

Unfavorable opinion regarding a medical device company’s proposal to pay a third-party vendor to access an electronic billing system operated by the vendor that is used by some of the requestor’s customers for certain billing operations.

Favorable opinion regarding assistance, including travel, lodging, and associated expenses, provided by a pharmaceutical manufacturer to qualifying patients receiving its gene therapy product and their caregivers.

Favorable opinion regarding a program operated by a pharmaceutical manufacturer to sponsor a companion laboratory test for eligible patients before a provider can prescribe a certain prescription drug manufactured by the pharmaceutical manufacturer.

Favorable opinion regarding a proposed arrangement pursuant to which a medical device manufacturer would offer up to $2,500 to reimburse purchasers for actual costs incurred associated with a needle stick injury caused by the failure of a device that it manufactures.

Unfavorable opinion regarding a medical device company’s proposal to pay the costs its customers otherwise would incur for a third-party company to screen and monitor the requestor for exclusion from Federal health care programs and to ensure compliance with certain other legal requirements.

Favorable opinion regarding a proposed arrangement whereby a management support organization and an affiliated professional corporation would enter into an agreement with telehealth providers to lease employees and provide certain administrative services.

Favorable opinion regarding an arrangement whereby Requestor— designated as a community health center pursuant to Section 330 of the Public Health Service Act—proposes, during the provision of certain social services to individuals, to: (1) identify individuals in need of primary care services; (2) inform them of the availability of such services; and (3) schedule an appointment for them to receive primary care services from Requestor or refer them to a local primary care provider.

Regarding the proposed subsidization of beneficiary cost-sharing obligations for Medicare-covered services provided as part of a clinical trial.

Favorable opinion regarding a program to provide free access to a pharmaceutical product to patients who meet financial and other eligibility criteria and who do not have adequate coverage for the product.

Favorable opinion regarding assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a cell therapy product manufactured by a pharmaceutical manufacturer.

Favorable opinion regarding the provision of meningococcal vaccinations to eligible patients prescribed one of two drugs that carry a heightened risk of contracting meningococcal disease.

Favorable opinion regarding a program to sponsor genetic testing, related genetic counseling, and disease-state awareness education regarding certain hereditary conditions that may cause kidney stones.

Favorable opinion regarding a dental supplies distributor’s proposed expansion of its existing customer loyalty program for purchases of dental-related items and services.

Favorable opinion regarding: a proposal for a municipal corporation to begin billing patients’ insurance plans—and waiving any patient cost- sharing amounts—for treatment-in-place emergency medical services without an associated ambulance transport.

Unfavorable advisory opinion regarding an entity’s proposal to share a percentage of its savings with certain groups to which it provides coverage through Employer Group Waiver Plans.

Favorable opinion regarding a proposed patient assistance program operated by a nonprofit grant-making organization.

Unfavorable opinion regarding proposed assistance for fertility services for qualifying patients receiving a gene therapy treatment developed by a biotechnology company.

Favorable in part and unfavorable in part opinion regarding proposed assistance for: (i) travel, lodging, meals, and associated expenses; and (ii) fertility preservation services for qualifying patients receiving one of two gene therapy treatments developed by a publicly traded biotechnology company.