[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3178 Engrossed in House (EH)]

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115th CONGRESS
  1st Session
                                H. R. 3178

_______________________________________________________________________

                                 AN ACT


 
To amend title XVIII of the Social Security Act to improve the delivery 
of home infusion therapy and dialysis and the application of the Stark 
        rule under the Medicare program, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medicare Part B 
Improvement Act of 2017''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
      TITLE I--IMPROVEMENTS IN PROVISION OF HOME INFUSION THERAPY

Sec. 101. Home infusion therapy services temporary transitional 
                            payment.
Sec. 102. Extension of Medicare Patient IVIG Access Demonstration 
                            Project.
Sec. 103. Orthotist's and prosthetist's clinical notes as part of the 
                            patient's medical record.
              TITLE II--IMPROVEMENTS IN DIALYSIS SERVICES

Sec. 201. Independent accreditation for dialysis facilities and 
                            assurance of high quality surveys.
Sec. 202. Expanding access to home dialysis therapy.
          TITLE III--IMPROVEMENTS IN APPLICATION OF STARK RULE

Sec. 301. Modernizing the application of the Stark rule under Medicare.
Sec. 302. Funds from the Medicare Improvement Fund.

      TITLE I--IMPROVEMENTS IN PROVISION OF HOME INFUSION THERAPY

SEC. 101. HOME INFUSION THERAPY SERVICES TEMPORARY TRANSITIONAL 
              PAYMENT.

    (a) In General.--Section 1834(u) of the Social Security Act (42 
U.S.C. 1395m(u)) is amended, by adding at the end the following new 
paragraph:
            ``(7) Home infusion therapy services temporary transitional 
        payment.--
                    ``(A) Temporary transitional payment.--
                            ``(i) In general.--The Secretary shall, in 
                        accordance with the payment methodology 
                        described in subparagraph (B) and subject to 
                        the provisions of this paragraph, provide a 
                        home infusion therapy services temporary 
                        transitional payment under this part to an 
                        eligible home infusion supplier (as defined in 
                        subparagraph (F)) for items and services 
                        described in subparagraphs (A) and (B) of 
                        section 1861(iii)(2)) furnished during the 
                        period specified in clause (ii) by such 
                        supplier in coordination with the furnishing of 
                        transitional home infusion drugs (as defined in 
                        clause (iii)).
                            ``(ii) Period specified.--For purposes of 
                        clause (i), the period specified in this clause 
                        is the period beginning on January 1, 2019, and 
                        ending on the day before the date of the 
                        implementation of the payment system under 
                        paragraph (1)(A).
                            ``(iii) Transitional home infusion drug 
                        defined.--For purposes of this paragraph, the 
                        term `transitional home infusion drug' has the 
                        meaning given to the term `home infusion drug' 
                        under section 1861(iii)(3)(C)), except that 
                        clause (ii) of such section shall not apply if 
                        a drug described in such clause is identified 
                        in clauses (i), (ii), (iii) or (iv) of 
                        subparagraph (C) as of the date of the 
                        enactment of this paragraph.
                    ``(B) Payment methodology.--For purposes of this 
                paragraph, the Secretary shall establish a payment 
                methodology, with respect to items and services 
                described in subparagraph (A)(i). Under such payment 
                methodology the Secretary shall--
                            ``(i) create the three payment categories 
                        described in clauses (i), (ii), and (iii) of 
                        subparagraph (C);
                            ``(ii) assign drugs to such categories, in 
                        accordance with such clauses;
                            ``(iii) assign appropriate Healthcare 
                        Common Procedure Coding System (HCPCS) codes to 
                        each payment category; and
                            ``(iv) establish a single payment amount 
                        for each such payment category, in accordance 
                        with subparagraph (D), for each infusion drug 
                        administration calendar day in the individual's 
                        home for drugs assigned to such category.
                    ``(C) Payment categories.--
                            ``(i) Payment category 1.--The Secretary 
                        shall create a payment category 1 and assign to 
                        such category drugs which are covered under the 
                        Local Coverage Determination on External 
                        Infusion Pumps (LCD number L33794) and billed 
                        with the following HCPCS codes (as identified 
                        as of July 1, 2017, and as subsequently 
                        modified by the Secretary): J0133, J0285, 
                        J0287, J0288, J0289, J0895, J1170, J1250, 
                        J1265, J1325, J1455, J1457, J1570, J2175, 
                        J2260, J2270, J2274, J2278, J3010, or J3285.
                            ``(ii) Payment category 2.--The Secretary 
                        shall create a payment category 2 and assign to 
                        such category drugs which are covered under 
                        such local coverage determination and billed 
                        with the following HCPCS codes (as identified 
                        as of July 1, 2017, and as subsequently 
                        modified by the Secretary): J1559 JB, J1561 JB, 
                        J1562 JB, J1569 JB, or J1575 JB.
                            ``(iii) Payment category 3.--The Secretary 
                        shall create a payment category 3 and assign to 
                        such category drugs which are covered under 
                        such local coverage determination and billed 
                        with the following HCPCS codes (as identified 
                        as of July 1, 2017, and as subsequently 
                        modified by the Secretary): J9000, J9039, 
                        J9040, J9065, J9100, J9190, J9200, J9360, or 
                        J9370.
                            ``(iv) Infusion drugs not otherwise 
                        included.--With respect to drugs that are not 
                        included in payment category 1, 2, or 3 under 
                        clause (i), (ii), or (iii), respectively, the 
                        Secretary shall assign to the most appropriate 
                        of such categories, as determined by the 
                        Secretary, drugs which are--
                                    ``(I) covered under such local 
                                coverage determination and billed under 
                                HCPCS codes J7799 or J7999 (as 
                                identified as of July 1, 2017, and as 
                                subsequently modified by the 
                                Secretary); or
                                    ``(II) billed under any code that 
                                is implemented after the date of the 
                                enactment of this paragraph and 
                                included in such local coverage 
                                determination or included in 
                                subregulatory guidance as a home 
                                infusion drug described in subparagraph 
                                (A)(i).
                    ``(D) Payment amounts.--
                            ``(i) In general.--Under the payment 
                        methodology, the Secretary shall pay eligible 
                        home infusion suppliers, with respect to items 
                        and services described in subparagraph (A)(i) 
                        furnished during the period described in 
                        subparagraph (A)(ii) by such supplier to an 
                        individual, at amounts equal to the amounts 
                        determined under the physician fee schedule 
                        established under section 1848 for services 
                        furnished during the year for codes and units 
                        of such codes described in clauses (ii), (iii), 
                        and (iv) with respect to drugs included in the 
                        payment category under subparagraph (C) 
                        specified in the respective clause, determined 
                        without application of the geographic 
                        adjustment under subsection (e) of such 
                        section.
                            ``(ii) Payment amount for category 1.--For 
                        purposes of clause (i), the codes and units 
                        described in this clause, with respect to drugs 
                        included in payment category 1 described in 
                        subparagraph (C)(i), are one unit of HCPCS code 
                        96365 plus four units of HCPCS code 96366 (as 
                        identified as of July 1, 2017, and as 
                        subsequently modified by the Secretary).
                            ``(iii) Payment amount for category 2.--For 
                        purposes of clause (i), the codes and units 
                        described in this clause, with respect to drugs 
                        included in payment category 2 described in 
                        subparagraph (C)(i), are one unit of HCPCS code 
                        96369 plus four units of HCPCS code 96370 (as 
                        identified as of July 1, 2017, and as 
                        subsequently modified by the Secretary).
                            ``(iv) Payment amount for category 3.--For 
                        purposes of clause (i), the codes and units 
                        described in this clause, with respect to drugs 
                        included in payment category 3 described in 
                        subparagraph (C)(i), are one unit of HCPCS code 
                        96413 plus four units of HCPCS code 96415 (as 
                        identified as of July 1, 2017, and as 
                        subsequently modified by the Secretary).
                    ``(E) Clarifications.--
                            ``(i) Infusion drug administration day.--
                        For purposes of this subsection, a reference, 
                        with respect to the furnishing of transitional 
                        home infusion drugs or home infusion drugs to 
                        an individual by an eligible home infusion 
                        supplier, to payment to such supplier for an 
                        infusion drug administration calendar day in 
                        the individual's home shall refer to payment 
                        only for the date on which professional 
                        services (as described in section 
                        1861(iii)(2)(A)) were furnished to administer 
                        such drugs to such individual. For purposes of 
                        the previous sentence, an infusion drug 
                        administration calendar day shall include all 
                        such drugs administered to such individual on 
                        such day.
                            ``(ii) Treatment of multiple drugs 
                        administered on same infusion drug 
                        administration day.--In the case that an 
                        eligible home infusion supplier, with respect 
                        to an infusion drug administration calendar day 
                        in an individual's home, furnishes to such 
                        individual transitional home infusion drugs 
                        which are not all assigned to the same payment 
                        category under subparagraph (C), payment to 
                        such supplier for such infusion drug 
                        administration calendar day in the individual's 
                        home shall be a single payment equal to the 
                        amount of payment under this paragraph for the 
                        drug, among all such drugs so furnished to such 
                        individual during such calendar day, for which 
                        the highest payment would be made under this 
                        paragraph.
                    ``(F) Eligible home infusion suppliers.--In this 
                paragraph, the term `eligible home infusion supplier' 
                means a supplier that is enrolled under this part as a 
                pharmacy that provides external infusion pumps and 
                external infusion pump supplies and that maintains all 
                pharmacy licensure requirements in the State in which 
                the applicable infusion drugs are administered.
                    ``(G) Implementation.--Notwithstanding any other 
                provision of law, the Secretary may implement this 
                paragraph by program instruction or otherwise.''.
    (b) Conforming Amendment.--Section 1842(b)(6)(I) of the Social 
Security Act (42 U.S.C. 1395u(b)(6)(I)) is amended by inserting ``or, 
in the case of items and services described in clause (i) of section 
1834(u)(7)(A) furnished to an individual during the period described in 
clause (ii) of such section, payment shall be made to the eligible home 
infusion therapy supplier'' after ``payment shall be made to the 
qualified home infusion therapy supplier''.

SEC. 102. EXTENSION OF MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 
              PROJECT.

    Section 101(b) of the Medicare IVIG Access and Strengthening 
Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C. 1395l note) is 
amended--
            (1) in paragraph (1), by inserting after ``for a period of 
        3 years'' the following: ``and, subject to the availability of 
        funds under subsection (g)--
                    ``(A) if the date of enactment of the Medicare Part 
                B Improvement Act of 2017 is on or before September 30, 
                2017, for the period beginning on October 1, 2017, and 
                ending on December 31, 2020; and
                    ``(B) if the date of enactment of such Act is after 
                September 30, 2017, for the period beginning on the 
                date of enactment of such Act and ending on December 
                31, 2020''''; and
            (2) in paragraph (2), by adding at the end the following 
        new sentences: ``Subject to the preceding sentence, a Medicare 
        beneficiary enrolled in the demonstration project on September 
        30, 2017, shall be automatically enrolled during the period 
        beginning on the date of the enactment of the Medicare Part B 
        Improvement Act of 2017 and ending on December 31, 2020, 
        without submission of another application. Chapter 35 of title 
        44, United States Code, shall not apply to any application form 
        used for a Medicare beneficiary who enrolls in the 
        demonstration project on or after such date of enactment.''.

SEC. 103. ORTHOTIST'S AND PROSTHETIST'S CLINICAL NOTES AS PART OF THE 
              PATIENT'S MEDICAL RECORD.

    Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) is 
amended by adding at the end the following new paragraph:
            ``(5) Documentation created by orthotists and 
        prosthetists.--For purposes of determining the reasonableness 
        and medical necessity of orthotics and prosthetics, 
        documentation created by an orthotist or prosthetist shall be 
        considered part of the individual's medical record to support 
        documentation created by eligible professionals described in 
        section 1848(k)(3)(B).''.

              TITLE II--IMPROVEMENTS IN DIALYSIS SERVICES

SEC. 201. INDEPENDENT ACCREDITATION FOR DIALYSIS FACILITIES AND 
              ASSURANCE OF HIGH QUALITY SURVEYS.

    (a) Accreditation and Surveys.--
            (1) In general.--Section 1865 of the Social Security Act 
        (42 U.S.C. 1395bb) is amended--
                    (A) in subsection (a)--
                            (i) in paragraph (1), in the matter 
                        preceding subparagraph (A), by striking ``or 
                        the conditions and requirements under section 
                        1881(b)''; and
                            (ii) in paragraph (4), by inserting 
                        ``(including a renal dialysis facility)'' after 
                        ``facility''; and
                    (B) by adding at the end the following new 
                subsection:
    ``(e) With respect to an accreditation body that has received 
approval from the Secretary under subsection (a)(3)(A) for 
accreditation of provider entities that are required to meet the 
conditions and requirements under section 1881(b), in addition to 
review and oversight authorities otherwise applicable under this title, 
the Secretary shall (as the Secretary determines appropriate) conduct, 
with respect to such accreditation body and provider entities, any or 
all of the following as frequently as is otherwise required to be 
conducted under this title with respect to other accreditation bodies 
or other provider entities:
            ``(1) Validation surveys referred to in subsection (d).
            ``(2) Accreditation program reviews (as defined in section 
        488.8(c) of title 42 of the Code of Federal Regulations, or a 
        successor regulation).
            ``(3) Performance reviews (as defined in section 488.8(a) 
        of title 42 of the Code of Federal Regulations, or a successor 
        regulation).''.
            (2) Timing for acceptance of requests from accreditation 
        organizations.--Not later than 90 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall begin accepting requests from national 
        accreditation bodies for a finding described in section 
        1865(a)(3)(A) of the Social Security Act (42 U.S.C. 
        1395bb(a)(3)(A)) for purposes of accrediting provider entities 
        that are required to meet the conditions and requirements under 
        section 1881(b) of such Act (42 U.S.C. 1395rr(b)).
    (b) Requirement for Timing of Surveys of New Dialysis Facilities.--
Section 1881(b)(1) of the Social Security Act (42 U.S.C. 1395rr(b)(1)) 
is amended by adding at the end the following new sentence: ``Beginning 
180 days after the date of the enactment of this sentence, an initial 
survey of a provider of services or a renal dialysis facility to 
determine if the conditions and requirements under this paragraph are 
met shall be initiated not later than 90 days after such date on which 
both the provider enrollment form (without regard to whether such form 
is submitted prior to or after such date of enactment) has been 
determined by the Secretary to be complete and the provider's 
enrollment status indicates approval is pending the results of such 
survey.''.

SEC. 202. EXPANDING ACCESS TO HOME DIALYSIS THERAPY.

    (a) Allowing Use of Telehealth for Monthly End Stage Renal Disease-
Related Visits.--
            (1) In general.--Paragraph (3) of section 1881(b) of the 
        Social Security Act (42 U.S.C. 1395rr(b)) is amended--
                    (A) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively;
                    (B) in clause (i), as redesignated by subparagraph 
                (A), by striking ``under this subparagraph'' and 
                inserting ``under this clause'';
                    (C) in clause (ii), as redesignated by subparagraph 
                (A), by inserting ``subject to subparagraph (B),'' 
                before ``on a comprehensive'';
                    (D) by striking ``With respect to'' and inserting 
                ``(A) With respect to''; and
                    (E) by adding at the end the following new 
                subparagraph:
    ``(B)(i) Subject to clause (ii), an individual who is determined to 
have end stage renal disease and who is receiving home dialysis may 
choose to receive monthly end stage renal disease-related visits, 
furnished on or after January 1, 2019, via telehealth.
    ``(ii) Clause (i) shall apply to an individual only if the 
individual receives a face-to-face visit, without the use of 
telehealth--
            ``(I) in the case of the initial 3 months of home dialysis 
        of such individual, at least monthly; and
            ``(II) after such initial 3 months, at least once every 3 
        consecutive months.''.
            (2) Conforming amendment.--Paragraph (1) of such section is 
        amended by striking ``paragraph (3)(A)'' and inserting 
        ``paragraph (3)(A)(i)''.
    (b) Expanding Originating Sites for Telehealth To Include Renal 
Dialysis Facilities and the Home for Purposes of Monthly End Stage 
Renal Disease-Related Visits.--
            (1) In general.--Section 1834(m) of the Social Security Act 
        (42 U.S.C. 1395m(m)) is amended--
                    (A) in paragraph (4)(C)(ii), by adding at the end 
                the following new subclauses:
                                    ``(IX) A renal dialysis facility, 
                                but only for purposes of section 
                                1881(b)(3)(B).
                                    ``(X) The home of an individual, 
                                but only for purposes of section 
                                1881(b)(3)(B).''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(5) Treatment of home dialysis monthly esrd-related 
        visit.--The geographic requirements described in paragraph 
        (4)(C)(i) shall not apply with respect to telehealth services 
        furnished on or after January 1, 2019, for purposes of section 
        1881(b)(3)(B), at an originating site described in subclause 
        (VI), (IX), or (X) of paragraph (4)(C)(ii)), subject to 
        applicable State law requirements, including State licensure 
        requirements.''.
            (2) No facility fee if originating site for home dialysis 
        therapy is the home.--Section 1834(m)(2)(B) of the Social 
        Security (42 U.S.C. 1395m(m)(2)(B)) is amended--
                    (A) by redesignating clauses (i) and (ii) as 
                subclauses (I) and (II), respectively, and by indenting 
                each of such subclauses 2 ems to the right;
                    (B) in subclause (II), as redesignated by 
                subparagraph (A), by striking ``clause (i) or this 
                clause'' and inserting ``subclause (I) or this 
                subclause'';
                    (C) by striking ``site.--With respect to'' and 
                inserting ``site.--
                            ``(i) In general.--Subject to clause (ii), 
                        with respect to''; and
                    (D) by adding at the end the following new clause:
                            ``(ii) No facility fee if originating site 
                        for home dialysis therapy is the home.--No 
                        facility fee shall be paid under this 
                        subparagraph to an originating site described 
                        in subclause (X) of paragraph (4)(C)(ii).''.
    (c) Clarification Regarding Telehealth Provided to Beneficiaries.--
Section 1128A(i)(6) of the Social Security Act (42 U.S.C. 1320a-
7a(i)(6)) is amended--
            (1) in subparagraph (H), by striking ``; or'' and inserting 
        a semicolon;
            (2) in subparagraph (I), by striking the period at the end 
        and inserting ``; or''; and
            (3) by adding at the end the following new subparagraph:
                    ``(J) the provision of telehealth technologies on 
                or after January 1, 2019, to individuals with end stage 
                renal disease under title XVIII by a health care 
                provider for the purpose of furnishing of 
                telehealth.''.
    (d) Study and Report on Further Expansion.--
            (1) Study.--The Comptroller General of the United States 
        shall conduct a study to examine the feasibility, benefits, and 
        drawbacks of expanding the use of telehealth and store-and-
        forward technologies under the Medicare program under title 
        XVIII of the Social Security Act for items and services 
        included in renal dialysis services, as such term is defined in 
        section 1881(b)(14)(B) of such Act (42 U.S.C. 
        1395rr(b)(14)(B)).
            (2) Report.--Not later than 2 years after the date of the 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report on the results of the study conducted under 
        paragraph (1).

          TITLE III--IMPROVEMENTS IN APPLICATION OF STARK RULE

SEC. 301. MODERNIZING THE APPLICATION OF THE STARK RULE UNDER MEDICARE.

    (a) Clarification of the Writing Requirement and Signature 
Requirement for Arrangements Pursuant to the Stark Rule.--
            (1) Writing requirement.--Section 1877(h)(1) of the Social 
        Security Act (42 U.S.C. 1395nn(h)(1)) is amended by adding at 
        the end the following new subparagraph:
            ``(D) Written requirement clarified.--In the case of any 
        requirement pursuant to this section for a compensation 
        arrangement to be in writing, such requirement shall be 
        satisfied by such means as determined by the Secretary, 
        including by a collection of documents, including 
        contemporaneous documents evidencing the course of conduct 
        between the parties involved.''.
            (2) Signature requirement.--Section 1877(h)(1) of the 
        Social Security Act (42 U.S.C. 1395nn(h)(1)), as amended by 
        paragraph (1), is further amended by adding at the end the 
        following new subparagraph:
                    ``(E) Special rule for signature requirements.--In 
                the case of any requirement pursuant to this section 
                for a compensation arrangement to be in writing and 
                signed by the parties, such signature requirement shall 
                be met if--
                            ``(i) not later than 90 consecutive 
                        calendar days immediately following the date on 
                        which the compensation arrangement became 
                        noncompliant, the parties obtain the required 
                        signatures; and
                            ``(ii) the compensation arrangement 
                        otherwise complies with all criteria of the 
                        applicable exception.''.
    (b) Indefinite Holdover for Lease Arrangements and Personal 
Services Arrangements Pursuant to the Stark Rule.--Section 1877(e) of 
the Social Security Act (42 U.S.C. 1395nn(e)) is amended--
            (1) in paragraph (1), by adding at the end the following 
        new subparagraph:
                    ``(C) Holdover lease arrangements.--In the case of 
                a holdover lease arrangement for the lease of office 
                space or equipment, which immediately follows a lease 
                arrangement described in subparagraph (A) for the use 
                of such office space or subparagraph (B) for the use of 
                such equipment and that expired after a term of at 
                least 1 year, payments made by the lessee to the lessor 
                pursuant to such holdover lease arrangement, if--
                            ``(i) the lease arrangement met the 
                        conditions of subparagraph (A) for the lease of 
                        office space or subparagraph (B) for the use of 
                        equipment when the arrangement expired;
                            ``(ii) the holdover lease arrangement is on 
                        the same terms and conditions as the 
                        immediately preceding arrangement; and
                            ``(iii) the holdover arrangement continues 
                        to satisfy the conditions of subparagraph (A) 
                        for the lease of office space or subparagraph 
                        (B) for the use of equipment.''; and
            (2) in paragraph (3), by adding at the end the following 
        new subparagraph:
                    ``(C) Holdover personal service arrangement.--In 
                the case of a holdover personal service arrangement, 
                which immediately follows an arrangement described in 
                subparagraph (A) that expired after a term of at least 
                1 year, remuneration from an entity pursuant to such 
                holdover personal service arrangement, if--
                            ``(i) the personal service arrangement met 
                        the conditions of subparagraph (A) when the 
                        arrangement expired;
                            ``(ii) the holdover personal service 
                        arrangement is on the same terms and conditions 
                        as the immediately preceding arrangement; and
                            ``(iii) the holdover arrangement continues 
                        to satisfy the conditions of subparagraph 
                        (A).''.

SEC. 302. FUNDS FROM THE MEDICARE IMPROVEMENT FUND.

    Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)) is amended by striking ``during and after fiscal year 
2021, $270,000,000'' and inserting ``during and after fiscal year 2021, 
$245,000,000''.

            Passed the House of Representatives July 25, 2017.

            Attest:

                                                                 Clerk.
115th CONGRESS

  1st Session

                               H. R. 3178

_______________________________________________________________________

                                 AN ACT

To amend title XVIII of the Social Security Act to improve the delivery 
of home infusion therapy and dialysis and the application of the Stark 
        rule under the Medicare program, and for other purposes.