H 1958
Version: Introduced
Author: Berkley
HR 1958 IH
112th CONGRESS
1st Session
H. R. 1958
To amend title XVIII of the Social Security Act to modify the designation of
accreditation organizations for orthotics and prosthetics, to apply
accreditation and licensure requirements to suppliers of such devices and items
for purposes of payment under the Medicare program, and to modify the payment
rules for such devices and items under such program to account for practitioner
qualifications and complexity of care.
IN THE HOUSE OF REPRESENTATIVES
May 24, 2011
MS. BERKLEY (for herself, Mr. Thompson of Pennsylvania, Mr. Ruppersberger, Mr.
Guthrie, and Mr. Neal ) introduced the following bill; which was referred to
the Committee on Energy and Commerce, and in addition to the Committee on Ways
and Means, for a period to be subsequently determined by the Speaker, in each
case for consideration of such provisions as fall within the jurisdiction of
the committee concerned
A BILL
To amend title XVIII of the Social Security Act to modify the designation of
accreditation organizations for orthotics and prosthetics, to apply
accreditation and licensure requirements to suppliers of such devices and items
for purposes of payment under the Medicare program, and to modify the payment
rules for such devices and items under such program to account for practitioner
qualifications and complexity of care.
Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled,
SEC. 1. SHORT TITLE This Act may be cited as the " Medicare Orthotics and
Prosthetics Improvement Act of 2011 ".
SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE UNDER MEDICARE TO DESIGNATION
OF ACCREDITATION ORGANIZATIONS FOR SUPPLIERS OF ORTHOTICS AND PROSTHETICS
(a) IN GENERAL Section 1834(a)(20)(B) of the Social Security Act (42 U.S.C.
1395m(a)(20)(B)) is amended --
(1) by striking "Not later than " and inserting "(i) In general . -- Subject to
clause (ii), not later than " with the same indentation as the clauses added by
paragraph (2); and
(2) by adding at the end the following new clauses:
" (ii) SPECIAL REQUIREMENTS FOR ACCREDITATION OF SUPPLIERS OF ORTHOTICS AND
PROSTHETICS For purposes of applying quality standards under subparagraph (A)
for suppliers (other than suppliers described in clause (iii)) of items and
services described in subparagraph (D)(ii), the Secretary shall designate and
approve an independent accreditation organization under clause (i) only if such
organization is a Board or program described in subsection (h)(1)(F)(iv). Not
later than January 1, 2012, the Secretary shall ensure that at least one
independent accreditation organization is designated and approved in accordance
with this clause.
" (iii) EXCEPTION Suppliers described in this clause are physicians,
occupational therapists, or physical therapists who are licensed or otherwise
regulated by the State in which they are practicing and who receive payment
under this title, including regulations promulgated pursuant to this
subsection. " .
(b) EFFECTIVE DATE An organization must satisfy the requirement of section
1834(a)(20)(B)(ii), as added by subsection (a)(2), not later than January 1,
2012, regardless of whether such organization is designated or approved as an
independent accreditation organization before, on, or after the date of the
enactment of this Act.
SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND LICENSURE REQUIREMENTS TO
CERTAIN PROSTHETICS AND CUSTOM-FABRICATED OR CUSTOM-FITTED ORTHOTICS
(a) IN GENERAL Section 1834(h)(1)(F) of the Social Security Act (42 U.S.C.
1395m(h)(1)(F)) is amended --
(1) in the heading, by inserting " or custom-fitted " after " custom-fabricated
";
(2) in clause (i), by striking "an item of custom-fabricated orthotics
described in clause (ii) or for an item of prosthetics unless such item is "
and inserting "an item of orthotics or prosthetics, including an item of
custom-fabricated orthotics described in clause (ii), unless such item is ";
(3) in clause (ii)(II), by striking "a list of items to which this subparagraph
applies " and inserting "a list of items for purposes of clause (i) "; and
(4) in clause (iii)(III), by striking "to provide or manage the provision of
prosthetics and custom-designed or -fabricated orthotics " and inserting "to
provide or manage the provision of orthotics and prosthetics (and
custom-designed or -fabricated orthotics, in the case of an item described in
clause (ii)) ".
(b) EFFECTIVE DATE The amendments made by subsection (a) shall apply to
orthotics and prosthetics furnished on or after January 1, 2012.
SEC. 4. MEDICARE PAYMENT RULES FOR ORTHOTICS AND PROSTHETICS TO ACCOUNT FOR
PRACTITIONER QUALIFICATIONS AND COMPLEXITY OF CARE Section 1834(h) of the
Social Security Act ( 42 U.S.C. 1395m(h) ) is amended --
(1) in paragraph (1)(F)(iii), by striking "other individual who " and inserting
"other individual who, with respect to a category of orthotics and prosthetics
care described in clause (i), (ii), (iii), (iv), or (v) of paragraph (5)(C)
furnished on or after January 1, 2012, and subject to paragraph (5)(A),
satisfies all applicable criteria of the provider qualification designation for
such category described in the respective clause, and who ";
(2) in paragraph (1)(F)(iv), by inserting before the period the following:
"and, with respect to a category of orthotics and prosthetics care described in
clause (i), (ii), (iii), (iv), or (v) of paragraph (5)(C) furnished on or after
January 1, 2012, and subject to paragraph (5)(A), satisfies all applicable
criteria of the provider qualification designation for such category described
in the respective clause "; and
(3) by adding at the end the following new paragraph:
" (5) PAYMENT RULES TO ACCOUNT FOR PRACTITIONER QUALIFICATIONS AND COMPLEXITY
OF CARE
" (A) CONSIDERATIONS FOR PAYMENTS
" (i) IN GENERAL In applying clauses (iii) and (iv) of paragraph (1)(F) for
purposes of determining whether payment may be made under this subsection for
orthotics and prosthetics furnished on or after January 1, 2012, the Secretary
shall take into account the complexity of the respective item and, subject to
clauses (ii), (iii), and (iv), the qualifications of the individual or entity
furnishing and fabricating such respective item in accordance with this
paragraph.
" (ii) INDIVIDUAL AND ENTITIES EXEMPTED FROM PROVIDER QUALIFICATION DESIGNATION
CRITERIA With respect to an item of orthotics or prosthetics described in
clause (ii), (iii), (iv) or (v) of subparagraph (C), any criteria for the
provider qualification designations under such respective clause, including
application of subparagraph (D), shall not apply to physicians, occupational
therapists, or physical therapists who are licensed or otherwise regulated by
the State in which they are practicing and who receive payment under this
title, including regulations promulgated pursuant to this subsection, for the
provision of orthotics and prosthetics.
" (iii) PRACTITIONERS MEDICARE-ELIGIBLE PRIOR TO JANUARY 1, 2013 EXEMPTED In
the case of a qualified practitioner or qualified supplier who is eligible to
receive payment under this title before January 1, 2013 --
" (I) with respect to an item of orthotics or prosthetics described in clause
(i) of subparagraph (C), any criteria for the provider qualification
designations under such clause, including application of subparagraph (D),
shall not apply to such practitioner or supplier, respectively, for the
furnishing or fabrication of such an item so described; and
" (II) with respect to an item of orthotics or prosthetics described in clause
(ii), (iii), or (iv) of subparagraph (C), any criteria for the provider
qualification designations under the respective clause (or a subsequent clause
of such subparagraph), including application of subparagraph (D), shall not
apply to such practitioner or supplier, respectively, for the furnishing or
fabrication of such an item described in such respective (or such subsequent)
clause.
" (iv) DELAYED APPLICATION OF CERTAIN PROVIDER QUALIFICATION DESIGNATION
CRITERIA The provider qualification designations under clauses (i), (ii), and
(iii) of subparagraph (C), including the application of subparagraph (D) to
such clauses, shall not be taken into account with respect to payment made
under this subsection for orthotics and prosthetics furnished before January 1,
2013.
" (v) MODIFICATIONS The Secretary shall, in consultation with the boards and
programs described in paragraph (1)(F)(iv), periodically review the criteria
for the provider qualification designation under subparagraph (C)(i)(III) and
may implement by regulation any modifications to such criteria, as determined
appropriate in accordance with such consultation. Any such modification shall
take effect no earlier than January 1, 2014.
" (B) ASSIGNMENT OF BILLING CODES For purposes of subparagraph (A), the
Secretary, in consultation with representatives of the fields of occupational
therapy, physical therapy, orthotics, and prosthetics shall utilize and
incorporate the set of L-codes listed, as of the date of the enactment of this
paragraph, in the Centers for Medicare & Medicaid Services document
entitled Transmittal 656 (CMS Pub. 100-04, Change Request 3959, August 19,
2005) and the 2008 Orthotics and Prosthetics Tripartite Document, a
multi-organization compilation of HCPCS codes. Transmittal 656 shall be the
controlling source of category, product, and code assignments for the orthotics
and prosthetics care described in each of clauses (i) through (v) of
subparagraph (C) using the provider qualification designation for each HCPCS
code as stated in such document and, in cases in which Transmittal 656 does not
include a particular item of orthotics or prosthetics or a related code or in
cases in which Transmittal 656 is revoked or abridged, the 2008 Orthotics and
Prosthetics Tripartite Document shall be the secondary source for such
category, product, and code assignments. In the case that either of the
documents described in the previous sentence is updated or reissued, the
previous sentence shall be applied with respect to the most recent update or
reissuance of such document.
" (C) CATEGORIES OF ORTHOTIC AND PROSTHETIC CARE DESCRIBED
" (i) CUSTOM FABRICATED LIMB PROSTHETICS CATEGORY The category of orthotic and
prosthetic care described in this clause is a category for artificial legs and
arms, including replacements (as described in section 1861(s)(9)) that are made
from detailed measurements, images, or models in accordance with a prescription
and that can only be utilized by a specific intended patient and for which
payment is made under this part. The provider qualification designation for the
category shall reflect each of the following, in accordance with subparagraph
(D):
" (I) The category of care involves the highest level of complexity with
substantial clinical risk.
" (II) The category of care requires a practitioner who satisfies any of the
education requirements described in subclause (III), has completed a prosthetic
residency accredited by the National Commission on Orthotic and Prosthetic
Education ( "NCOPE "), and is certified or licensed in prosthetics to ensure
the comprehensive provision of prosthetic care.
" (III) The category of care requires a practitioner who has completed any of
the following education requirements:
" (aa) A bachelor's degree or master's degree in prosthetics as offered by
educational institutions accredited by the Commission on Accreditation of
Allied Health Education Programs.
" (bb) A bachelor's degree, plus a certificate in prosthetics as offered by
educational institutions accredited by the Commission on Accreditation of
Allied Health Education Programs.
" (cc) A foreign degree determined by the World Education Service to be
equivalent to an educational program in prosthetics accredited by the
Commission on Accreditation of Allied Health Education Programs.
" (ii) CUSTOM FABRICATED ORTHOTICS CATEGORY The category of orthotics and
prosthetics care described in this clause is a category for custom fabricated
orthotics that are made from detailed measurements, images, or models in
accordance with a prescription and that can only be utilized by a specific
intended patient. The provider qualification designation for the category shall
reflect the following, in accordance with subparagraph (D):
" (I) The category of care involves the highest level of complexity with
substantial clinical risk.
" (II) The category of care requires a practitioner who satisfies any of the
education requirements described in clause (i)(III) (except that for purposes
of this subclause such clause shall be applied by substituting the term
"orthotics " each place the term "prosthetics " is used), has completed an
orthotic residency accredited by the National Commission on Orthotic and
Prosthetic Education, and is certified or licensed in orthotics to ensure the
appropriate provision of orthotic care.
" (iii) CUSTOM FITTED HIGH ORTHOTICS CATEGORY The category of orthotic care
described in this clause is a category for prefabricated orthotics that are
manufactured with no specific patient in mind, but that are appropriately
sized, adapted, modified, and configured (with the required tools and
equipment) to a specific patient in accordance with a prescription. The
provider qualification designation for the category shall reflect the
following, in accordance with subparagraph (D):
" (I) The category of care involves moderate to high complexity with
substantial clinical risk.
" (II) The category of care requires a practitioner who either --
" (aa) satisfies any of the education requirements described in clause
(i)(III), except that for purposes of this subclause such clause shall be
applied by substituting the term "orthotics " each place the term "prosthetics
" is used; or
" (bb) is certified or licensed in orthotics to ensure the appropriate
provision of orthotic care within the practitioner's normal scope of practice.
" (iv) CUSTOM FITTED LOW ORTHOTICS CATEGORY The category of orthotics and
prosthetics care described in this clause is a category for prefabricated
orthotics that are manufactured with no specific patient in mind, but that are
appropriately sized and adjusted to a specific patient in accordance with a
prescription. The provider qualification designation for the category shall
reflect the following:
" (I) The category of care involves a low level of complexity and low clinical
risk.
" (II) The category of care requires a supplier that is certified or licensed
within a limited scope of practice to ensure appropriate provision of orthotic
care. The supplier's education and training shall ensure that basic clinical
knowledge and technical expertise is available to confirm successful fit and
device compliance with the prescription.
" (v) OFF-THE-SHELF The category of orthotic care described in this clause is a
category for prefabricated orthotics that require minimal self adjustment for
appropriate use. The provider qualification designation for the category shall
reflect that such orthotics do not require expertise in trimming, bending,
molding, assembling, or customizing to fit the patient and that no formal
credentialing, clinical education, or technical training is required to
dispense such items.
" (D) CARE BASED ON SOUND CLINICAL JUDGMENT AND TECHNICAL EXPERTISE Care
described in clauses (i), (ii), and (iii) of subparagraph (C) shall be based on
sound clinical judgment and technical expertise based on the practitioner's
education and clinical training, in order to allow the practitioner to
determine --
" (i) with respect to care described in clause (i) and (ii) of subparagraph
(C), the device parameters and design, fabrication process, and functional
purpose specific to the needs of the patient to maximize optimal clinical
outcomes; and
" (ii) with respect to care described in subparagraph (C)(iii), the appropriate
device relative to the diagnosis and specific to the needs of the patient to
maximize optimal clinical outcomes.
" (E) CONSULTATION In modifying the payment basis, the Secretary shall consult
with appropriate experts in orthotics and prosthetics, including practitioners
that furnish items within the categories of prosthetics and orthotics care
described in subparagraph (C). " .
SEC. 5. REPORTS
(a) REPORT ON ENFORCING NEW LICENSING AND ACCREDITATION REQUIREMENTS Not later
than 18 months after the date of the enactment of this Act, the Secretary of
Health and Human Services shall submit to Congress a report on the steps taken
by the Department of Health and Human Services to ensure that the State
licensure and accreditation requirements under section 1834(h)(1)(F) of the
Social Security Act, as amended by section 3, are enforced. Such report shall
include a determination of the extent to which payments for orthotics and
prosthetics under the Medicare program under title XVIII of such Act are made
only to those providers of services and suppliers that meet the relevant
accreditation and licensure requirements under such section, as well as a
determination of whether additional steps are needed.
(b) REPORT ON FRAUD AND ABUSE Not later than 30 months after the date of the
enactment of this Act, the Secretary of Health and Human Services shall submit
to Congress a report on the effect of the requirements under subsection
(a)(20)(B)(ii) of section 1834 of the Social Security Act ( 42 U.S.C. 1395m ),
as added by section 2, and subsection (h)(1)(F) of such section, as amended by
section 3, on the occurrence of fraud and abuse under the Medicare program
under title XVIII of such Act, with respect to orthotics and prosthetics for
which payment is made under such program.
SEC. 6. REDUCTION IN MEDICARE SPENDING Not later than December 31, 2012, the
Secretary of Health and Human Services, acting through the Chief Actuary of the
Centers for Medicare & Medicaid Services, shall submit to Congress, and
have published in the Federal Register, a projection of the effect on
cumulative Federal spending under part B of title XVIII of the Social Security
Act for the period of years 2012 through 2016 that will result from the
implementation of this Act, including the amendments made by this Act. If the
Chief Actuary projects that the implementation of the amendments made by this
Act will not result in a cumulative reduction in spending under such part of at
least $250,000,000 for the period of years 2012 through 2016 (using a 2011
baseline), the Secretary shall, in accordance with the Actuary's projection,
issue an interim final regulation (to take effect for 2014 and subsequent
years) with comment period to strengthen the licensure, accreditation, and
quality standards applicable to suppliers of orthotics and prosthetics, as
described in this Act (and amendments made by this Act), in order to produce
such cumulative reduction by the end of 2016, except that such regulation shall
not apply to a qualified physical therapist or qualified occupational therapist
(as described in section 1834(h)(1)(F)(iii) of the Social Security Act ( 42
U.S.C. 1395m(h)(1)(F)(iii) ).