https://www.gpo.gov/fdsys/pkg/PLAW-113publ93/html/PLAW-113publ93.htm
PAMA Section 218/Appropriate Use Criteria (Clipped; becomes SSA 1834(q)):
(b) Promoting Evidence-Based Care.--
(1) In general.--Section 1834 of the Social Security Act (42
U.S.C. 1395m), as amended by subsection (a), is amended by
adding at the end the following new subsection:
``(q) Recognizing Appropriate Use Criteria for Certain Imaging
Services.--
``(1) Program established.--
``(A) In general.--The Secretary shall establish a
program to promote the use of appropriate use criteria
(as defined in subparagraph (B)) for applicable imaging
services (as defined in subparagraph (C)) furnished in
an applicable setting (as defined in subparagraph (D))
by ordering professionals and furnishing professionals
(as defined in subparagraphs (E) and (F), respectively).
``(B) Appropriate use criteria defined.--In this
subsection, the term `appropriate use criteria' means
criteria, only developed or endorsed by national
professional medical specialty societies or other
provider-led entities, to assist ordering professionals
and furnishing professionals in making the most
appropriate treatment decision for a specific clinical
condition for an individual. To the extent feasible,
such criteria shall be evidence-based.
``(C) Applicable imaging service defined.--In this
subsection, the term `applicable imaging service' means
an advanced diagnostic imaging service (as defined in
subsection (e)(1)(B)) for which the Secretary
determines--
``(i) one or more applicable appropriate use
criteria specified under paragraph (2) apply;
``(ii) there are one or more qualified
clinical decision support mechanisms listed under
paragraph (3)(C); and
``(iii) one or more of such mechanisms is
available free of charge.
``(D) Applicable setting defined.--In this
subsection, the term `applicable setting' means a
physician's office, a hospital outpatient department
(including an emergency department), an ambulatory
surgical center, and any other provider-led outpatient
setting determined appropriate by the Secretary.
``(E) Ordering professional defined.--In this
subsection, the term `ordering professional' means a
physician (as defined in section 1861(r)) or a
practitioner described in section 1842(b)(18)(C) who
orders an applicable imaging service.
``(F) Furnishing professional defined.--In this
subsection, the term `furnishing professional' means a
physician (as defined in section 1861(r)) or a
practitioner described in section 1842(b)(18)(C) who
furnishes an applicable imaging service.
``(2) Establishment of applicable appropriate use
criteria.--
[[Page 128 STAT. 1066]]
``(A) <<NOTE: Deadline. Regulations. Consultation.>> In
general.--Not later than November 15, 2015, the
Secretary shall through rulemaking, and in consultation
with physicians, practitioners, and other stakeholders,
specify applicable appropriate use criteria for
applicable imaging services only from among appropriate
use criteria developed or endorsed by national
professional medical specialty societies or other
provider-led entities.
``(B) Considerations.--In specifying applicable
appropriate use criteria under subparagraph (A), the
Secretary shall take into account whether the criteria--
``(i) have stakeholder consensus;
``(ii) are scientifically valid and evidence
based; and
``(iii) are based on studies that are
published and reviewable by stakeholders.
``(C) <<NOTE: Review. Deadline.>> Revisions.--The
Secretary shall review, on an annual basis, the
specified applicable appropriate use criteria to
determine if there is a need to update or revise (as
appropriate) such specification of applicable
appropriate use criteria and make such updates or
revisions through rulemaking.
``(D) Treatment of multiple applicable appropriate
use criteria.--In the case where the Secretary
determines that more than one appropriate use criterion
applies with respect to an applicable imaging service,
the Secretary shall apply one or more applicable
appropriate use criteria under this paragraph for the
service.
``(3) Mechanisms for consultation with applicable
appropriate use criteria.--
``(A) Identification of mechanisms to consult with
applicable appropriate use criteria.--
``(i) In general.--The Secretary shall specify
qualified clinical decision support mechanisms
that could be used by ordering professionals to
consult with applicable appropriate use criteria
for applicable imaging services.
``(ii) Consultation.--The Secretary shall
consult with physicians, practitioners, health
care technology experts, and other stakeholders in
specifying mechanisms under this paragraph.
``(iii) Inclusion of certain mechanisms.--
Mechanisms specified under this paragraph may
include any or all of the following that meet the
requirements described in subparagraph (B)(ii):
``(I) Use of clinical decision
support modules in certified EHR
technology (as defined in section
1848(o)(4)).
``(II) Use of private sector
clinical decision support mechanisms
that are independent from certified EHR
technology, which may include use of
clinical decision support mechanisms
available from medical specialty
organizations.
``(III) Use of a clinical decision
support mechanism established by the
Secretary.
``(B) Qualified clinical decision support
mechanisms.--
[[Page 128 STAT. 1067]]
``(i) In general.--For purposes of this
subsection, a qualified clinical decision support
mechanism is a mechanism that the Secretary
determines meets the requirements described in
clause (ii).
``(ii) Requirements.--The requirements
described in this clause are the following:
``(I) The mechanism makes available
to the ordering professional applicable
appropriate use criteria specified under
paragraph (2) and the supporting
documentation for the applicable imaging
service ordered.
``(II) In the case where there is
more than one applicable appropriate use
criterion specified under such paragraph
for an applicable imaging service, the
mechanism indicates the criteria that it
uses for the service.
``(III) The mechanism determines the
extent to which an applicable imaging
service ordered is consistent with the
applicable appropriate use criteria so
specified.
``(IV) The mechanism generates and
provides to the ordering professional a
certification or documentation that
documents that the qualified clinical
decision support mechanism was consulted
by the ordering professional.
``(V) The mechanism is updated on a
timely basis to reflect revisions to the
specification of applicable appropriate
use criteria under such paragraph.
``(VI) The mechanism meets privacy
and security standards under applicable
provisions of law.
``(VII) The mechanism performs such
other functions as specified by the
Secretary, which may include a
requirement to provide aggregate
feedback to the ordering professional.
``(C) <<NOTE: Deadlines.>> List of mechanisms for
consultation with applicable appropriate use criteria.--
``(i) <<NOTE: Publication.>> Initial list.--
Not later than April 1, 2016, the Secretary shall
publish a list of mechanisms specified under this
paragraph.
``(ii) Periodic updating of list.--The
Secretary shall identify on an annual basis the
list of qualified clinical decision support
mechanisms specified under this paragraph.
``(4) Consultation with applicable appropriate use
criteria.--
``(A) Consultation by ordering professional.--
Beginning <<NOTE: Effective date.>> with January 1,
2017, subject to subparagraph (C), with respect to an
applicable imaging service ordered by an ordering
professional that would be furnished in an applicable
setting and paid for under an applicable payment system
(as defined in subparagraph (D)), an ordering
professional shall--
``(i) consult with a qualified decision
support mechanism listed under paragraph (3)(C);
and
[[Page 128 STAT. 1068]]
``(ii) provide to the furnishing professional
the information described in clauses (i) through
(iii) of subparagraph (B).
``(B) <<NOTE: Effective date.>> Reporting by
furnishing professional.--Beginning with January 1,
2017, subject to subparagraph (C), with respect to an
applicable imaging service furnished in an applicable
setting and paid for under an applicable payment system
(as defined in subparagraph (D)), payment for such
service may only be made if the claim for the service
includes the following:
``(i) Information about which qualified
clinical decision support mechanism was consulted
by the ordering professional for the service.
``(ii) Information regarding--
``(I) whether the service ordered
would adhere to the applicable
appropriate use criteria specified under
paragraph (2);
``(II) whether the service ordered
would not adhere to such criteria; or
``(III) whether such criteria was
not applicable to the service ordered.
``(iii) The national provider identifier of
the ordering professional (if different from the
furnishing professional).
``(C) Exceptions.--The provisions of subparagraphs
(A) and (B) and paragraph (6)(A) shall not apply to the
following:
``(i) Emergency services.--An applicable
imaging service ordered for an individual with an
emergency medical condition (as defined in section
1867(e)(1)).
``(ii) Inpatient services.--An applicable
imaging service ordered for an inpatient and for
which payment is made under part A.
``(iii) Significant hardship.--An applicable
imaging service ordered by an ordering
professional who the Secretary may, on a case-by-
case basis, exempt from the application of such
provisions if the Secretary determines, subject to
annual renewal, that consultation with applicable
appropriate use criteria would result in a
significant hardship, such as in the case of a
professional who practices in a rural area without
sufficient Internet access.
``(D) Applicable payment system defined.--In this
subsection, the term `applicable payment system' means
the following:
``(i) The physician fee schedule established
under section 1848(b).
``(ii) The prospective payment system for
hospital outpatient department services under
section 1833(t).
``(iii) The ambulatory surgical center payment
systems under section 1833(i).
``(5) Identification of outlier ordering professionals.--
``(A) <<NOTE: Effective date. Determination.>> In
general.--With respect to applicable imaging services
furnished beginning with 2017, the Secretary shall
determine, on an annual basis, no more than five percent
[[Page 128 STAT. 1069]]
of the total number of ordering professionals who are
outlier ordering professionals.
``(B) Outlier ordering professionals.--The
determination of an outlier ordering professional
shall--
``(i) be based on low adherence to applicable
appropriate use criteria specified under paragraph
(2), which may be based on comparison to other
ordering professionals; and
``(ii) include data for ordering professionals
for whom prior authorization under paragraph
(6)(A) applies.
``(C) Use of two years of data.--The Secretary shall
use two years of data to identify outlier ordering
professionals under this paragraph.
``(D) Process.--The Secretary shall establish a
process for determining when an outlier ordering
professional is no longer an outlier ordering
professional.
``(E) Consultation with stakeholders.--The Secretary
shall consult with physicians, practitioners and other
stakeholders in developing methods to identify outlier
ordering professionals under this paragraph.
``(6) Prior authorization for ordering professionals who are
outliers.--
``(A) <<NOTE: Effective date.>> In general.--
Beginning January 1, 2020, subject to paragraph (4)(C),
with respect to services furnished during a year, the
Secretary shall, for a period determined appropriate by
the Secretary, apply prior authorization for applicable
imaging services that are ordered by an outlier ordering
professional identified under paragraph (5).
``(B) Appropriate use criteria in prior
authorization.--In applying prior authorization under
subparagraph (A), the Secretary shall utilize only the
applicable appropriate use criteria specified under this
subsection.
``(C) Funding.--For purposes of carrying out this
paragraph, the Secretary shall provide for the transfer,
from the Federal Supplementary Medical Insurance Trust
Fund under section 1841, of $5,000,000 to the Centers
for Medicare & Medicaid Services Program Management
Account for each of fiscal years 2019 through 2021.
Amounts transferred under the preceding sentence shall
remain available until expended.
``(7) Construction.--Nothing in this subsection shall be
construed as granting the Secretary the authority to develop or
initiate the development of clinical practice guidelines or
appropriate use criteria.''.
(2) Conforming amendment.--Section 1833(t)(16) of the Social
Security Act (42 U.S.C. 1395l(t)(16)) is amended by adding at
the end the following new subparagraph:
``(E) Application of appropriate use criteria for
certain imaging services.--For provisions relating to
the application of appropriate use criteria for certain
imaging services, see section 1834(q).''.
(3) Report on experience of imaging appropriate use criteria
program.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report that includes
[[Page 128 STAT. 1070]]
a description of the extent to which appropriate use criteria
could be used for other services under part B of title XVIII of
the Social Security Act (42 U.S.C. 1395j et seq.), such as
radiation therapy and clinical diagnostic laboratory services.
....SEC. 219. USING FUNDING FROM TRANSITIONAL FUND FOR SUSTAINABLE
GROWTH RATE (SGR) REFORM.
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