[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2479 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2479

     To amend title XVIII of the Social Security Act to modify the 
 designation of accreditation organizations for prosthetic devices and 
    orthotics and prosthetics, to apply accreditation and licensure 
 requirements to 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 19, 2009

 Ms. Berkley 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 prosthetic devices and 
    orthotics and prosthetics, to apply accreditation and licensure 
 requirements to 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 2009''.

SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE UNDER MEDICARE TO 
              DESIGNATION OF ACCREDITATION ORGANIZATIONS FOR SUPPLIERS 
              OF PROSTHETIC DEVICES AND 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 clause added by paragraph (2); and
            (2) by adding at the end the following new clause:
                            ``(ii) Special requirements for 
                        accreditation of prosthetic devices and 
                        orthotics and prosthetics.--For purposes of 
                        applying quality standards under subparagraph 
                        (A) for suppliers 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, 2010, 
                        the Secretary shall ensure that at least one 
                        independent accreditation organization is 
                        designated and approved in accordance with this 
                        clause.''.
    (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, 2010, 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 FOR CERTAIN PROSTHETICS AND CUSTOM-
              FABRICATED ORTHOTICS TO PROSTHETIC DEVICES AND ORTHOTICS 
              AND PROSTHETICS.

    (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 striking ``Special payment rules for 
        certain prosthetics and custom-fabricated orthotics'' and 
        inserting ``Payment rules'';
            (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 ``a prosthetic 
        device or an item of orthotics or prosthetics, including an 
        item of custom-fabricated orthotics described in clause (ii), 
        unless such device or item, respectively, 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 prosthetics and orthotics (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 devices and items furnished on or after January 1, 2010.

SEC. 4. MEDICARE PAYMENT RULES FOR PROSTHETIC DEVICES AND 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, 2010, 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) and furnished on or after 
        January 1, 2010, 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) 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 
                prosthetic devices and orthotics and prosthetics 
                furnished on or after January 1, 2010, the Secretary 
                shall take into account the complexity of the 
                respective item and the qualifications of the 
                individual or entity furnishing and fabricating such 
                respective item in accordance with this paragraph.
                    ``(B) Assignment of billing codes.--For purposes of 
                subparagraph (A), the Secretary shall utilize and 
                incorporate the set of L-codes listed, as of the date 
                of the enactment of this paragraph, in the `2008 
                Orthotics and Prosthetics Tripartite Document', a 
                multi-organization compilation of HCPCS codes, to 
                assign specific billing codes to the category of 
                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. In the case that such 
                document 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 orthotics and prosthetics care 
                described.--
                            ``(i) Custom fabricated prosthetics 
                        category.--The category of orthotics and 
                        prosthetics care described in this clause is a 
                        category for custom fabricated prosthetics 
                        devices 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:
                                    ``(I) The category of care involves 
                                the highest level of complexity with 
                                substantial clinical risk.
                                    ``(II) The category of care 
                                requires a practitioner who is educated 
                                and trained with a course of study 
                                specific to and is credentialed, 
                                certified, or licensed in prosthetics 
                                to ensure the comprehensive provision 
                                of prosthetic care. Such care 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 the device 
                                parameters and design, fabrication 
                                process, and functional purpose 
                                specific to the needs of the patient to 
                                maximize optimal clinical outcomes.
                            ``(ii) Custom fabricated orthotics 
                        category.--The category of orthotics and 
                        prosthetics care described in this clause is a 
                        category for custom fabricated orthotics 
                        devices 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:
                                    ``(I) The category of care involves 
                                the highest level of complexity with 
                                substantial clinical risk.
                                    ``(II) The category of care 
                                requires a practitioner who is educated 
                                and trained with a course of study 
                                specific to orthotics and is 
                                credentialed, certified, or licensed in 
                                orthotics to ensure the appropriate 
                                provision of orthotic care. Such care 
                                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 the 
                                device parameters and design, 
                                fabrication process, and functional 
                                purpose specific to the needs of the 
                                patient to maximize optimal clinical 
                                outcomes.
                            ``(iii) Custom fitted high.--The category 
                        of orthotics and prosthetics care described in 
                        this clause is a category for prefabricated 
                        orthotics devices 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:
                                    ``(I) The category of care involves 
                                moderate to high complexity with 
                                substantial clinical risk.
                                    ``(II) The category of care 
                                requires a practitioner who is educated 
                                and trained with a course of study 
                                specific to orthotics and is 
                                credentialed, certified, or licensed in 
                                orthotics to ensure the appropriate 
                                provision of orthotic care. Such care 
                                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 the 
                                appropriate device relative to the 
                                diagnosis and specific to the needs of 
                                the patient to maximize optimal 
                                clinical outcomes.
                            ``(iv) Custom fitted low.--The category of 
                        orthotics and prosthetics care described in 
                        this clause is a category for prefabricated 
                        orthotics devices 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 
                                credentialed, certified, or licensed 
                                within a limited scope of practice to 
                                ensure appropriate provision of 
                                orthotic care. The supplier's education 
                                and training shall insure 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 
                        orthotics and prosthetics care described in 
                        this clause is a category for prefabricated 
                        devices that require minimal self adjustment 
                        for appropriate use. The provider qualification 
                        designation for the category shall reflect that 
                        such devices 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 
                        devices.
                    ``(D) Consultation.--In modifying the payment 
                basis, the Secretary shall consult with appropriate 
                experts in orthotics and prosthetics, including 
                practitioners that furnish devices and items within the 
                categories of prosthetics and orthotics care described 
                in subparagraph (C).
                    ``(E) Budget neutrality.--This paragraph shall be 
                applied in a manner to result in the same aggregate 
                amount of expenditures for prosthetic devices and 
                orthotics and prosthetics under this section for a year 
                as would be made if this paragraph did not apply, as 
                estimated by the Secretary.''.

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 prosthetic devices 
and 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 prosthetic devices and orthotics and 
prosthetics for which payment is made under such program.

SEC. 6. RULES OF CONSTRUCTION.

    (a) Scope of Practice.--Nothing in this Act shall be construed as 
superceding or otherwise affecting a provision of State law insofar as 
such law relates to the scope of practice for occupational therapists, 
physical therapists, or both.
    (b) No Effect on Other Services.--Nothing in this Act shall be 
construed as modifying the ability, in existence as of the date of the 
enactment of this Act, of a physical therapist or occupational 
therapist to provide services for which payment may be made under title 
XVIII of the Social Security Act if such services are completely 
distinct from the fabrication and sale of prosthetic devices and 
orthotics and prosthetics described in section 1834(h)(4) of the Social 
Security Act (42 U.S.C. 1395m(h)(4)), such as assisting in adapting or 
using such devices, gate training, or other equivalent services.
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