Establishing requirements for use of artificial intelligence in prior authorization denials under Medicare Advantage

(a)

In general

Section 1852 of the Social Security Act (42 U.S.C. 1395w–22) is amended by adding at the end the following new subsection:

(o)

Requirements for use of artificial intelligence in prior authorization denials

(1)

In general

With respect to plan years beginning on or after January 1, 2027, an MA plan that imposes a prior authorization requirement with respect to an item or service for which benefits are available under such plan may not deny a request for prior authorization with respect to such item or service based on the output of artificial intelligence, unless the following requirements are met: (A)Before such denial is issued, such denial is reviewed and approved, under the clinical direction of a medical director of such MA plan, by a qualified physician reviewer. (B)Such qualified physician reviewer provides to such MA plan a signed attestation that, in reviewing and approving such denial— (i)such qualified physician reviewer exercised medical judgment that was independent from such output; (ii)such denial was not generated or dictated by artificial intelligence; and (iii)any software used in preparing such denial was used only for administrative purposes. (C)Such MA plan provides to the provider who submitted such request— (i)a copy of the signed attestation described in subparagraph (B); (ii)an opportunity to communicate directly with such qualified physician reviewer; and (iii)an opportunity to discuss with such qualified physician reviewer the proposed individualized clinical basis for such denial. (D)Such MA plan discloses to the individual to whom such denial is issued and to such provider— (i)that artificial intelligence was used as part of such denial; and (ii)the National Provider Identifier number of such qualified physician reviewer. (E)Such MA plan makes, and maintains for not less than 10 years after the date on which such denial is issued, records with respect to such denial about— (i)the use of artificial intelligence; (ii)the review and approval by such qualified physician reviewer under subparagraph (A); and (iii)information provided under subparagraph (C), including a copy of the signed attestation described in subparagraph (B). (2)

Report to Secretary

Not later than March 31, 2027, and every 90 days thereafter, an MA plan that imposes a prior authorization requirement with respect to an item or service for which benefits are available under such plan shall submit to the Secretary a report that includes, with respect to the most recent 90-day period for which such data is available, information with respect to any requests for prior authorization for such an item or service that were denied based on the output of artificial intelligence, including— (A)any signed attestations provided under paragraph (1)(B); and (B)any algorithm, decision protocol, or documentation associated with such output. (3)

Oversight authority

In the case of an MA plan that imposes a prior authorization requirement with respect to an item or service for which benefits are available under such plan, the Secretary may audit and inspect any use of artificial intelligence by such plan that is associated with such requirement, including by— (A)reviewing data related to denials of requests for prior authorization; (B)examining whether qualified physician reviewers provided signed attestations under paragraph (1)(B); (C)reviewing such signed attestations; (D)comparing outputs of artificial intelligence to denials of requests for prior authorization; (E)assessing the rates of such denials that were overturned or did not satisfy the requirements of paragraph (1); (F)reviewing internal policies; (G)interviewing employees; and (H)reviewing any algorithm, decision protocol, or documentation related to such use. (4)

Definitions

In this subsection: (A)

Artificial intelligence

The term artificial intelligence has the meaning given such term in section 5002 of the National Artificial Intelligence Initiative Act of 2020 (15 U.S.C. 9401) and includes technology that— (i)produces synthetic content in response to prompts using patterns learned from data; (ii)acts with autonomy and purpose by executing tasks proactively and independently with minimal or no human intervention; and (iii)interfaces with external systems and tools to take meaningful action, make decisions, set goals, and operate beyond initial training data. (B)

Qualified physician reviewer

The term qualified physician reviewer means, with respect to an item or service for which a request for prior authorization is submitted to an MA plan, a physician who— (i)possesses a current and valid non-restricted license to practice medicine in the State where such item or service will be furnished; (ii)is board-certified or eligible under the rules and guidelines of the American Board of Medical Specialties or American Osteopathic Association in a specialty that correlates with the specialty of the provider who submitted such request; and (iii)has experience practicing in such specialty.

(b)

Promulgation of regulations

Not later than 1 year after the date of the enactment of this section, the Secretary shall issue a final rule to carry out the amendments made by this section.