Browse Advisory Opinions

Favorable opinion regarding an arrangement pursuant to which a precision oncology company provides consenting patients a supplemental report at no cost in connection with a cancer screening test.

Unfavorable opinion regarding a proposed arrangement whereby an orthopedic medical technology company would enter into agreements with individuals—often physicians—who would provide consulting services for its product lines.

Favorable opinion regarding a proposal to enter into certain lease arrangements to create a centralized location for providing a range of items and services to patients with hearing loss who may be candidates for cochlear implants.

Favorable opinion regarding a pediatric dental and orthodontic services provider’s proposal to provide free, comprehensive orthodontic treatment to one of its existing patients per year.

Favorable opinion regarding a proposal by an entity and its Medicare Advantage subsidiaries that offer Employer Group Waiver Plans to share a percentage of their savings with certain groups to which they provide coverage, in certain circumstances.

Favorable opinion regarding a State-designated domestic crisis provider’s proposal to bill Federal health care programs for therapy services furnished by Requestor’s employed mental health professionals and to waive any cost sharing for such services.

Favorable opinion regarding a proposal to subsidize certain cost-sharing obligations in the context of a clinical trial.

Favorable opinion regarding a medical technology manufacturer and distributor’s proposal to offer to certain ambulatory surgery centers a discount on intraocular lenses and other surgical supplies used to perform cataract surgery, contingent on affiliated physician practices purchasing its software product.

Favorable opinion regarding the transfer of ownership interests by the sole shareholder of a Medicare certified ambulatory surgical center in anticipation of his retirement from medical practice.

Favorable opinion regarding a proposal from an entity that manages urgent care centers to operate a laboratory that would provide services to patients of the urgent care centers it manages.

Favorable opinion regarding a proposal by a manufacturer of a clinical laboratory test for colorectal cancer screening to waive any applicable cost sharing for certain commercially insured patients who receive its colorectal cancer screening test.

Unfavorable opinion regarding a proposal for a home care agency to market sign-on bonuses to prospective employees with the intention of employing those individuals for the provision of services to other individuals, who most often would be family members of the prospective employees.

Favorable opinion regarding certain discount structures that that a pharmaceutical manufacturer offers on particular vaccines.

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.