[Congressional Record Volume 158, Number 27 (Friday, February 17, 2012)]
[Senate]
[Pages S910-S912]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. WYDEN (for himself, Ms. Snowe, and Mr. Grassley):
S. 2125. 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; to the Committee on Finance.
Mr. WYDEN. Mr. President, I rise today on behalf of patients,
practitioners and the American taxpayer to introduce the Medicare
Orthotics and Prosthetics Improvement Act of 2012 with my colleagues,
Senators Snowe and Grassley.
The current orthotics and prosthetics, O&P, market is ripe for fraud
and abuse. Unqualified and dishonest practitioners are taking advantage
of patients and Medicare by providing substandard O&P products and
manipulating the Medicare payment system. No rule has been implemented
on the Federal level which would require these practitioners and
providers to be licensed or accredited, despite calls from Congress to
do so, and therefore all comers are able to bill Medicare on the
taxpayer's dime.
Congress and the Centers for Medicare and Medicaid Services have
tried to address this issue in the past, but have come up short. In
both 2000 and 2003, Congress passed legislation which should have
increased the qualification standards for these providers.
Unfortunately, nothing came of these efforts and a decade later we have
a system in place that does little to discourage fraud and abuse in
these fields.
One department, however, has stepped up and taken the lead on this
issue: the Department of Veterans Affairs. After a program evaluation
showed that VA O&P Laboratories did not meet quality standards they
changed their policy so that only accredited laboratories and
individuals may fabricate prostheses and orthoses.
The rest of the country must follow the VA's lead in order to ensure
that patients from Oregon to Maine have access to high quality
orthotics and prosthetics from a trusted source. Our legislation
accomplishes this goal through measures that would improve the
oversight of O&P practitioners.
The Medicare Orthotics and Prosthetics Improvement Act would get rid
of unqualified practitioners by prohibiting CMS from making any
Medicare payment for orthotics and prosthetics to a practitioner who
has not secured a license in those states that require licensure.
Again, this requirement was issued by CMS in 2005 but has not yet been
implemented. Practitioners in states without licensure requirements
would need to become accredited in order to continue practicing. The
accreditation standard would be identical to the standard adopted by
the Veterans Administration in 2004.
The legislation goes a step further by requiring that the Medicare
payment is matched to the qualification of the provider and the
complexity of the patient's needs and the device provided. This
provision will protect patients from suppliers with little or no
education and training to provide comprehensive O&P services, while
rewarding providers who have secured more advanced training and
practice on more complex patients.
These common sense reforms will benefit patients, qualified
practitioners and taxpayers. I urge my colleagues to join Senators
Snowe, Grassley and me in supporting this legislation.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the text of the bill was ordered to be
printed in the Record, as follows:
S. 2125
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 2012''.
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 ``organizations.--Not later than'' and
inserting ``organizations.--
``(i) In general.--Subject to clause (ii), not later
than''; and
(2) by adding after clause (i), as added by paragraph (1),
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, 2013, 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
[[Page S911]]
(a)(2), not later than January 1, 2013, 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)'';
(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))''; and
(5) by adding at the end the following new clause:
``(v) Exemption of off-the-shelf orthotics included in a
competitive acquisition program.--This subparagraph shall not
apply to an item of orthotics described in paragraph (2)(C)
of section 1847(a) furnished on or after January 1, 2013,
that is included in a competitive acquisition program in a
competitive acquisition area under such section.''.
(b) Effective Date.--The amendments made by subsection (a)
shall apply to orthotics and prosthetics furnished on or
after January 1, 2013.
SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR ORTHOTICS AND
PROSTHETICS BASED ON 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), in the matter preceding
subclause (I), 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, 2013, 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, 2013, 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) Eligibility for payment based on practitioner
qualifications and complexity of care.--
``(A) Considerations for eligibility 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, 2013, 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,
2014.
``(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, 2015.
``(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
[[Page S912]]
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 described in section
1847(a)(2)(C). The provider qualification designation for the
category shall reflect 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) or (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 clause (iii) of
such subparagraph, the appropriate device relative to the
diagnosis and specific to the needs of the patient to
maximize optimal clinical outcomes.''.
SEC. 5. CONSULTATION.
In implementing the provisions of, and amendments made by,
this Act, the Secretary of Health and Human Services shall
consult with appropriate experts in orthotics and
prosthetics, including practitioners that furnish items
within the categories of orthotic and prosthetic care
described in section 1834(h)(5)(C) of the Social Security
Act, as added by section 4.
SEC. 6. 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 and 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. 7. REDUCTION IN MEDICARE SPENDING.
(a) Projection of Cumulative Effect on Spending.--Not later
than December 31, 2013, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary''),
acting through the Chief Actuary of the Centers for Medicare
& Medicaid Services (in this section referred to as the
``Chief Actuary''), 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 2013 through
2017 as a result of the implementation of the provisions of,
and amendments made by, this Act.
(b) Strengthening Standards Applicable if Savings Not
Achieved.--
(1) In general.--Subject to paragraph (2), if the Chief
Actuary projects under subsection (a) that the implementation
of the provisions of, and 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 2013
through 2017 (using a 2012 baseline), the Secretary shall, in
accordance with the Chief Actuary's projection, issue an
interim final regulation (to take effect for 2014 and
subsequent years) with a period for public comment on such
regulation after the date of publication to strengthen the
licensure, accreditation, and quality standards applicable to
suppliers of orthotics and prosthetics under title XVIII of
the Social Security Act, including such standards described
in subsections (a)(20) and (h)(1)(F) of section 1834 of such
Act (42 U.S.C. 1395m), as amended by this Act, in order to
produce such cumulative reduction by December 31, 2017.
(2) Exception.--The interim final regulation issued under
paragraph (1) 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))).
SEC. 8. NO EFFECT ON PAYMENT BASIS FOR ORTHOTICS AND
PROSTHETICS OR COMPETITIVE BIDDING PROGRAMS.
Nothing in the provisions of, or amendments made by, this
Act shall have any effect on--
(1) the determination of the payment basis for orthotics
and prosthetics under section 1834(h) of the Social Security
Act (42 U.S.C. 1395m(h)); or
(2) the implementation of competitive acquisition programs
under section 1847 of such Act (42 U.S.C. 1395w 3), including
such implementation with respect to off-the-shelf orthotics
described in subsection (a)(2)(C) of that section, that are
included in a competitive acquisition program in a
competitive acquisition area under that section.
____________________