[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.

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