A.__Ensure participation of participating providers, including physicians and pharmacists, in the development of the formulary; and

B.__Consistent with the standards for a utilization review under section 4304, provide for exceptions from the formulary limitation when a nonformulary alternative is medically indicated.

2.__Coverage of approved drugs and medical devices.__A carrier that provides any coverage of prescription drugs or medical devices may not deny coverage of such a drug or device on the basis that the use is investigational if the use:

A.__In the case of a prescription drug:

(1)__Is included in the labeling authorized by the application in effect for the drug pursuant to the Federal Food, Drug, and Cosmetics Act, Section 505, subsection (b) or (j), without regard to any postmarketing requirements that may apply under that Act; or

(2)__Is included in the labeling authorized by the application in effect for the drug under the federal Public Health Service Act, Section 351, without regard to any postmarketing requirements that may apply pursuant to that section; or

B.__In the case of a medical device, is included in the labeling authorized by a regulation under the federal Food, Drug, and Cosmetics Act, Section 513, subsection (d) or (3); an order under Section 513, subsection (f) of that Act; or an application approved under Section 515 of that Act, without regard to any postmarketing requirements that may apply under that Act.

3.__Construction.__This section may not be construed to require a carrier to provide any coverage of prescription drugs or medical devices.

§4314.__Nondiscrimination in delivery of services

1.__Delivery of services.__A carrier may not discriminate against an enrollee in the delivery of health care services that are consistent with the benefits under the plan or coverage or as