[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2125 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2125

     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 SENATE OF THE UNITED STATES

                           February 17, 2012

  Mr. Wyden (for himself, Ms. Snowe, and Mr. Grassley) introduced the 
 following bill; which was read twice and referred to the Committee on 
                                Finance

_______________________________________________________________________

                                 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 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 (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 
                        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.
                                 <all>