shall use the information described in 
paragraph (3)(A) (if available) and shall 
issue a request for information from Medi-
care Advantage plans, providers, suppliers, 
beneficiary advocacy organizations, con-
sumer organizations, and other stake-
holders for purposes of identifying requests 
for a period under clause (ii). 
‘‘(iv) DEFINITION OF REAL-TIME DE-
CISION.— 
‘‘(I) IN
GENERAL.—In estab-
lishing the definition of a real-time 
decision for purposes of clause (i), the 
Secretary shall take into account cur-
rent medical practice, technology, 
health care industry standards, and 
other relevant information and factors 
to ensure the accurate and timely fur-
nishing of items and services to indi-
viduals. 
‘‘(II) UPDATE.—The Secretary 
shall update, not less often than once 
every 2 years, the definition of a real- 
time decision for purposes of clause 
(i), taking into account changes in 
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medical practice, changes in tech-
nology, changes in health care indus-
try standards, and other relevant in-
formation, such as the information 
submitted by Medicare Advantage 
plans under paragraph (3)(A)(i), and 
factors to ensure the accurate and 
timely furnishing of items and services 
to individuals. 
‘‘(v) 
IMPLEMENTATION.—The 
Sec-
retary shall use notice and comment rule-
making, which may include use of the an-
nual call letter process under this part, for 
each of the following: 
‘‘(I) Establishing the definition 
of a ‘real-time decision’ for purposes 
of clause (i). 
‘‘(II) Updating such definition 
pursuant to clause (iv)(II). 
‘‘(III) 
Identifying 
applicable 
items or services pursuant to clause 
(ii) for the initial period of 2 plan 
years as described in such clause. 
‘‘(IV) Updating the identification 
of such items and services for each 
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subsequent period of 2 plan years as 
described in such clause. 
‘‘(3) TRANSPARENCY REQUIREMENTS.— 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the transparency requirements 
specified in this paragraph are, with respect to 
a Medicare Advantage plan, the following: 
‘‘(i) The plan, annually and in a man-
ner specified by the Secretary, shall submit 
to the Secretary the following information: 
‘‘(I) A list of all applicable items 
and services that are described in sub-
section (a)(1)(B) that are subject to a 
prior authorization requirement under 
the plan. 
‘‘(II) The percentage of prior au-
thorization requests approved during 
the previous plan year by the plan in 
an initial determination with respect 
to each such item and service. 
‘‘(III) The percentage of such re-
quests that were initially denied and 
that were subsequently appealed in 
any manner, and the percentage of 
such appealed requests that were 
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overturned, with respect to each such 
item and service, broken down by each 
stage of appeal (including judicial re-
view). The plan may include informa-
tion regarding the number of initial 
denials due to request submissions 
that did not meet clinical evidence 
standards. 
‘‘(IV) The percentage of such re-
quests that were denied and the per-
centage of the total number of denied 
requests that were denied as a result 
of decision support technology or 
other clinical decision-making tools. 
‘‘(V) The average and the median 
amount of time (in hours) that 
elapsed during the previous plan year 
between the submission of such a re-
quest to the plan and a determination 
by the plan with respect to such re-
quest for each such item and service, 
excluding any such requests that did 
not contain all information required to 
be submitted by the plan. 
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‘‘(VI) A list that includes a de-
scription of each occurrence during 
the previous plan year in which the 
plan made a determination to approve 
or deny an item or service in the case 
where a provider furnished an addi-
tional or differing item or service dur-
ing the peroperative period of a sur-
gical or otherwise invasive procedure 
that such provider determined was 
medically necessary. 
‘‘(VII) A disclosure and descrip-
tion of any software decision-making 
tools the plan utilizes in making de-
terminations with respect to such re-
quests. 
‘‘(VIII) Such other information 
as the Secretary determines appro-
priate. 
‘‘(ii) The plan shall provide— 
‘‘(I) to each provider or supplier 
who seeks to enter into a contract 
with such plan to furnish applicable 
items and services under such plan, 
the list described in clause (i)(I) and 
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any policies or procedures used by the 
plan for making determinations with 
respect to prior authorization re-
quests; 
‘‘(II) to each such provider and 
supplier who does enter into such a 
contract, access to the criteria used by 
the plan for making such determina-
tions, including an itemization of the 
medical or other documentation re-
quired to be submitted by a provider 
or supplier with respect to such a re-
quest, except to the extent that provi-
sion of access to such criteria would 
disclose proprietary information of 
such plan; and 
‘‘(III) to each beneficiary subject 
to prior authorization under the plan, 
access to the criteria used by the plan 
for making such determinations, ex-
cept to the extent that provision of ac-
cess to such criteria would disclose 
proprietary information of such plan. 
‘‘(B) REGULATIONS.—The Secretary shall, 
through notice and comment rulemaking, pro-
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