HR 1958
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,
SECTION 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)).
END
