[Congressional Record (Bound Edition), Volume 163 (2017), Part 8]
[House]
[Pages 11508-11514]
[From the U.S. Government Publishing Office, www.gpo.gov]




                MEDICARE PART B IMPROVEMENT ACT OF 2017

  Mr. BRADY of Texas. Madam Speaker, I move to suspend the rules and 
pass the bill (H.R. 3178) 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3178

       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

[[Page 11509]]

     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 three months of home 
     dialysis of such individual, at least monthly; and
       ``(II) after such initial three months, at least once every 
     three 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).

[[Page 11510]]

       ``(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 two 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 one 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 one 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''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Texas (Mr. Brady) and the gentleman from Massachusetts (Mr. Neal) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Texas.


                             General Leave

  Mr. BRADY of Texas. Madam Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks and include extraneous material on H.R. 3178, currently 
under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. BRADY of Texas. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, improving and strengthening Medicare for the long term 
is a major priority for the American people and Members of Congress on 
both sides of the aisle; but as we pursue this larger goal, we should 
not pass up opportunities to make smart, focused improvements that will 
help Medicare beneficiaries today. That is exactly what the Medicare 
Part B Improvement Act will do.
  I introduced this bill with Ways and Means Ranking Member Richard 
Neal, Health Subcommittee Chairman Pat Tiberi, and Ranking Member 
Sander Levin. This legislation delivers targeted, immediate reforms to 
make Medicare work better for the American people, and it includes 
solutions from roughly one dozen Members of Congress on both sides of 
the aisle.
  The Medicare Part B Improvement Act takes action on three primary 
goals: first, expanding access to high-quality care; second, improving 
efficiency in the delivery of care so that patients can better receive 
the care they need when they need it; and, third, easing administrative 
burdens on healthcare providers so they can spend less time on 
paperwork and more time with patients.
  Importantly, H.R. 3178 extends and improves Medicare home infusion 
services, which allow patients to receive personalized care in the 
comfort of their own home.
  This legislation also extends an ongoing Medicare pilot program, the 
IVIG demonstration program, that allows patients with weakened immune 
systems to receive care in their homes.
  This demonstration program carries a lot of meaning for me. I 
introduced it in 2012 as a direct response to the challenges facing 
patients with immunodeficiency diseases.

                              {time}  1345

  As I learned from Carol Ann Demaret, a constituent and friend of mine 
whose son David suffered from severe combined immunodeficiency disease, 
life with a severely weakened immune system can be an incredible 
struggle. For children especially, it can be a daily fight just to 
survive.

[[Page 11511]]

  Allowing these vulnerable patients to receive treatment from the 
safety of their own home cannot only improve the quality of care, it 
can greatly enhance their quality of life. It can give a kid a real 
chance to be a kid.
  In addition to these important provisions, this bill contains 
numerous solutions that will lower healthcare costs and increase access 
to high-quality, coordinated care for beneficiaries.
  More than that, the bill is an excellent example of what we can 
accomplish through regular order. This legislation was approved 
unanimously by the Ways and Means Committee on July 13. It demonstrates 
how, working together, we can solve real challenges facing patients, 
families, and healthcare providers in our communities.
  I would like to thank all the Ways and Means members on both sides of 
the aisle who helped craft the solutions in this bill. I would also 
like to recognize Chairman Walden and Ranking Member Pallone of the 
Energy and Commerce Committee for their leadership and hard work in 
helping us move this bill forward.
  The Medicare Part B Improvement Act takes targeted action to make 
Medicare work better for the American people. I urge all of my 
colleagues to join me in supporting its passage.
  Madam Speaker, I reserve the balance of my time, and I ask unanimous 
consent that the gentleman from Ohio (Mr. Tiberi), chairman of the 
Health Subcommittee, be permitted to control the remainder of the time.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Mr. NEAL. Madam Speaker, I yield myself such time as I may consume.
  Madam Speaker, I stand in support of H.R. 3178, the Medicare Part B 
Improvement Act of 2017.
  I am pleased that Chairman Brady, along with Health Subcommittee 
Chairman Tiberi, Ranking Member Levin, and I worked in a bipartisan 
manner to draft this legislation. It brings together a number of 
important measures to improve Medicare part B. I encourage all of our 
colleagues to support it.
  As I said during the bipartisan Ways and Means Committee markup of 
H.R. 3178, I hope the committee will be able to hold more meetings like 
this. This is what the American people want and expect from their 
Members: to get things done in a bipartisan manner.
  The bill before us today is pretty straightforward. It makes 
important changes to Medicare part B in a number of ways. It includes a 
commonsense transitional policy for home infusion services, cosponsored 
by Mr. Tiberi and Mr. Pascrell.
  Our colleagues Mr. Bishop and Mr. Mike Thompson are cosponsors of 
language to streamline Medicare rules to improve access to medically 
necessary prosthetics and orthotics.
  Mr. John Lewis cosponsored language to help dialysis facilities 
improve backlogs so they can more efficiently treat end-stage renal 
disease.
  Ms. DelBene and Mr. Mike Thompson are cosponsors of a bill that 
allows telehealth so patients can receive dialysis in the comfort of 
their own home.
  Finally, the measure includes clarification language to Stark laws 
that Mr. Kind led to provide more certainty for Medicare providers.
  Our colleagues on both sides of the aisle worked hard on these bills, 
and I am pleased we can move them forward in a bipartisan manner.
  Madam Speaker, I encourage my colleagues to support H.R. 3178, and I 
reserve the balance of my time.
  Mr. TIBERI. Madam Speaker, I yield myself such time as I may consume.
  Madam Speaker, I stand in this Chamber today in strong support of 
H.R. 3178, a package of bipartisan policies centered on improving care 
for Medicare beneficiaries across several areas.
  In particular, H.R. 3178 includes a bill that I introduced with my 
friend and colleague from New Jersey, Mr. Bill Pascrell, that provides 
a temporary transitional payment for home infusion providers.
  The 21st Century Cures Act created a new reimbursement benefit for 
home infusion therapies beginning in 2021. This new temporary 
transitional payment will bridge the potential gap in care for 
beneficiaries, and home infusion providers will continue to administer 
these therapies without going bankrupt.
  This legislation includes other good public policies that further 
encourage giving seniors the choice to receive more care in the comfort 
of their own homes, as well as expanding access to providers, 
particularly in rural and in needy areas.
  I would like to thank my colleagues on the Ways and Means Committee 
for their support. I would also like to thank my colleagues on the 
Energy and Commerce Committee for their commitment to working on this 
issue, especially Michael Burgess, as well as Chairman Emeritus Fred 
Upton, who helped pave the way for these policies with the passage of 
the 21st Century Cures Act.
  Madam Speaker, I would like to conclude with a commitment that this 
is not an end for policies encouraging care--especially drug infusion--
in the home for patients who choose to do so. We look forward to 
working with the administration and clarifying current rules to ensure 
we successfully implement both this legislation and future policies to 
ensure inclusion of payment for all drugs needed by the home infusion 
patient community.
  Madam Speaker, I reserve the balance of my time.
  Mr. NEAL. Madam Speaker, I yield 3 minutes to the gentleman from 
California (Mr. Thompson).
  Mr. THOMPSON of California. Madam Speaker, I thank the gentleman for 
yielding.
  Madam Speaker, I rise in strong support of this legislation, and I 
want to thank all my colleagues who worked in a bipartisan manner to 
make it happen.
  Patients and providers in my district and across the country will 
benefit from these important improvements, and I am proud to support 
them.
  Two provisions come from bipartisan bills that I have worked on for a 
number of years. The first helps patients get the devices they need 
while keeping fraudulent providers out of Medicare. The change we are 
debating today will ensure that any documentation created by device 
experts will be included in a patient's medical record to support the 
physician's directions.
  The second provision that I authored comes from the comprehensive 
telehealth packages that I have been working on with Representative 
Black and our colleagues from the Energy and Commerce Committee, Mr. 
Welch and Mr. Harper. This change will allow for virtual visits and 
remote patient monitoring for kidney failure patients living at home. 
Letting these patients utilize telehealth ensures that they can access 
the services they need from the setting that they prefer: their homes.
  This bill is another step forward in the expansion of telehealth, but 
we can do a lot more. Our telehealth bills offer a menu of options for 
moving forward. Policies like paying for telestroke services or adding 
telehealth to the Medicare Advantage program have bipartisan support 
among both Houses, as well as a broad coalition of support from 
stakeholders.
  We know they save money. I have worked on telehealth for decades. 
When I was in the California State Senate, I wrote the State's first 
telehealth legislation to bring critical services to folks enrolled in 
the State Medicaid program. That was in 1996. Now it is 2017, and we 
still haven't passed, in Congress, comprehensive telehealth legislation 
that would expand access for Medicare beneficiaries.
  It is long past time for Congress to come to the conclusion that 
California reached long ago: telehealth saves money, and it saves 
lives. I am optimistic that the passage of this bill is just a small 
sample of what is to come in regard to telehealth in the future.
  Mr. TIBERI. Madam Speaker, I yield 2 minutes to the gentleman from 
Texas (Mr. Burgess), chairman of the Health Subcommittee of the Energy 
and Commerce Committee and a leader on healthcare issues.
  Mr. BURGESS. Madam Speaker, I thank the gentleman for yielding.

[[Page 11512]]

  Madam Speaker, I rise in support of H.R. 3178, the Medicare Part B 
Improvement Act of 2017.
  This bill represents a series of bipartisan reforms from the 
Committees on Energy and Commerce and Ways and Means that will provide 
targeted reforms to improve access to care for Medicare beneficiaries.
  Home infusion patients are oftentimes our Nation's sickest and most 
vulnerable, and maintaining access to these services in home settings 
has proved invaluable in ensuring that patients can continue to 
effectively receive the care that they need.
  Under last year's 21st Century Cures Act, we took the necessary steps 
to ensure that taxpayers and beneficiaries were no longer overcharged 
on the acquisition and dispensing costs associated with home infusion. 
Additionally, we took complementary steps to recognize the unique 
education needs associated with receiving infusion in the home.
  However, as my subcommittee learned in a hearing on this issue just 
last week, there is still more that must be done to integrate these two 
policies without jeopardizing access to patient care. Therefore, 
today's bill creates a bridge to connect these critical policies and to 
resolve the issue.
  Additionally, H.R. 3178 takes an additional needed step to protect 
home health services by expanding opportunities for individuals to 
receive home dialysis. Access to services like home infusion and home 
dialysis has had a significant impact in my home State of Texas, and I 
am encouraged by today's bill, as it will build upon these additional 
successes for Texans and all Americans.
  I would like to thank Chairman Brady, Chairman Tiberi, and Chairman 
Walden for their leadership on the bill. They rose to the challenge to 
address these tough policy decisions. This bill is a product of their 
hard work, as well as the hard work of all the staff involved at the 
subcommittee and full committee level, and I thank them as well.
  Mr. NEAL. Madam Speaker, I yield 2 minutes to the gentleman from New 
Jersey (Mr. Pascrell).
  Mr. PASCRELL. Madam Speaker, I rise today in support of H.R. 3178, 
the Medicare Part B Improvement Act.
  I am pleased that the bill before us today includes legislation that 
I introduced with my good friend Pat Tiberi from Ohio, the Medicare 
Part B Home Infusion Services Temporary Transitional Payment Act.
  Listening to Mr. Tiberi and Mr. Neal, I believe what they say should 
resonate across the Hill. This can't be one and done. Bipartisanship is 
something that should be contagious, particularly as we are talking 
about a healthcare event which is important and may mean life or death 
to many of our citizens.
  Home infusion is an essential treatment option for individuals 
suffering from many, many debilitating diseases like cancer, congestive 
heart failure, multiple sclerosis, and rheumatoid arthritis. The 21st 
Century Cures Act, which became law last year, correctly adjusted 
payments for home infusion drugs and would establish a new home 
infusion nursing benefit within Medicare beginning in 2021.
  However, we have heard concerns that the payment adjustment going 
into effect before the nursing benefit is implemented could jeopardize 
access to home infusion in the interim. The bill that Congressman 
Tiberi from Ohio and I introduced would address that concern by 
creating a temporary nursing benefit until the new permanent benefit 
can be implemented.
  Madam Speaker, I urge my colleagues to support H.R. 3178.
  Mr. TIBERI. Madam Speaker, I yield 2 minutes to the gentlewoman from 
Kansas (Ms. Jenkins), a valuable member of our Health Subcommittee of 
the Ways and Means Committee.
  Ms. JENKINS of Kansas. Madam Speaker, I rise today in support of H.R. 
3178, the Medicare Part B Improvement Act of 2017, which includes my 
legislation, the Dialysis Certification Act.
  Kansas currently ranks among the top three longest wait times for 
dialysis center surveys. The lack of manpower at the State 
administrative agency that contracts with CMS for these surveys has 
left some clinics waiting 2 years for a certification. This bill gives 
dialysis providers the opportunity to receive surveys and 
certifications from a CMS-approved third-party accreditor, much like 
hospitals are able to do now.

                              {time}  1400

  Those third-party organizations must demonstrate their standards are 
as good as or better than the standards used by CMS, and the Secretary 
must approve them.
  I toured several clinics in my district last year, and I was 
frustrated to learn that a state-of-the-art clinic, necessary to fill a 
need in Topeka for ESRD patients, has been waiting 2 years for an 
initial survey, and a clinic in Pittsburg, Kansas, has been waiting for 
250 days. Without these clinics, patients are forced to find clinics 
much further away, which, depending on the access to transportation, 
can be a barrier to treatment. That is unacceptable, and this problem 
will be easily solved by this provision.
  I want to thank my cosponsor, Congressman John Lewis, the Energy and 
Commerce Committee and the Ways and Means Committee chairmen for 
quickly moving this bill to the House floor for action. This provision 
will allow dialysis clinics across America to more easily obtain a 
survey so they may serve patients that depend on their care.
  Mr. NEAL. Madam Speaker, I yield 2 minutes to the gentlewoman from 
Washington (Ms. DelBene), who is a coauthor of this legislation.
  Ms. DelBENE. Madam Speaker, I would like to thank the chair and the 
ranking member for working with me to include a proposal in this bill 
that I developed with Congresswoman Black, Congressman Thompson, and 
Congressman Meehan modernizing Medicare and harnessing the promise of 
telehealth to improve care for patients nationwide.
  Allowing patients with end-stage renal disease to receive dialysis at 
home can dramatically improve their health outcomes and quality of 
life. This is something I have heard consistently from providers in my 
home State of Washington, like the Northwest Kidney Centers, who do 
incredible work to help patients receive dialysis at home when it is 
medically appropriate.
  Advances in telehealth hold great potential to extend this treatment 
option to more Americans, particularly in rural communities, but there 
are still too many barriers to the use of cutting-edge technologies in 
Medicare. There is a great need to update our laws to reflect these 
innovations and reimburse telehealth appropriately; otherwise, we won't 
just be denying access to healthcare today, we could be preventing the 
next frontier of innovations from even getting off the ground.
  Without the long-term visibility of Medicare coverage, startups and 
entrepreneurs might never get the funding they need to develop new 
technologies and bring them to market. It is essential that we unlock 
the full potential of telehealth. By doing so, we can improve patient 
care, promote health, defeat heartbreaking diseases, and save lives. 
That is why I am so glad we are taking this step today.
  Thank you again to the committee for working with me on this 
important bill, and I hope it is the first of many victories as we work 
together to expand telehealth.
  I urge my colleagues to vote ``yes.''
  Mr. TIBERI. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Tennessee (Mrs. Black), a valuable member of the Health Subcommittee of 
the Committee on Ways and Means and who, as you have already heard from 
previous speakers, has an important provision in this bill and who, 
more importantly, brings her valuable training as a nurse who practiced 
before she came to Congress.
  Mrs. BLACK. Mr. Speaker, I thank my colleague for yielding me time on 
this very important issue.
  I also want to thank my colleagues for working with me on this--Mr. 
Meehan, Mr. Thompson, and Ms. DelBene--for working on a really 
important piece of legislation that is included in this package, which 
will improve the quality of life for seniors on Medicare across the 
country.

[[Page 11513]]

  As has previously been said, I am a nurse. I have worked in the field 
for over 45 years, and I am proud to sponsor a bill that enhances 
patient care for those patients who are suffering from end-stage renal 
disease.
  You know, we have made tremendous advances in technology over the 
last decade, and now it would be almost something we couldn't have 
thought of 45 years ago. Physicians can remotely monitor patients in 
their dialysis treatments through telehealth to reduce the number of 
medical visits that are necessary, to ensure that the treatment is 
efficient and effective, and to also catch signs of complications 
early, which would cause not only a decrease in quality of care for the 
patient, but also a cost.
  Telehealth provides patients an important component in the comfort of 
their own homes--think about being sick and having to get in the car to 
travel--while physicians now have a new tool to treat their patients' 
whole health.
  Our seniors deserve access to this innovative care, and it can save 
money. It can help to ensure that Medicare can be there for seniors who 
most need the care.
  So I urge my colleagues to take a vote for your constituents and for 
Medicare beneficiaries across the country and support this bill.
  I also look forward to continuing this work. This is certainly not 
the end of what we can do for our patients who are homebound and need 
care in the home. I will continue this work with Members on both sides 
of the aisle, which is being done now, for our Nation's seniors to have 
access to these kinds of innovative telehealth technologies that will 
improve care and also, more importantly, help to lower the cost of 
treatment.
  I urge passage of this amendment.
  Mr. NEAL. Mr. Speaker, I yield 1 minute to the gentlewoman from 
California (Ms. Matsui), whose husband served with great distinction as 
a member of the Ways and Means Committee.
  Ms. MATSUI. Mr. Speaker, I rise today in support of H.R. 3178, the 
Medicare Part B Improvement Act, and, specifically, a provision to 
extend the IVIG demonstration project that Chairman Brady and I worked 
on together.
  I have long been a champion of those impacted by primary 
immunodeficiency diseases, which include more than 300 rare genetic 
diseases, all of which keep the immune system from functioning 
properly. A mild infection can cause serious problems and even death 
for these patients.
  Thanks to the IVIG demo, Medicare beneficiaries with immunodeficiency 
diseases are now able to receive in-home IVIG therapy, meaning they can 
avoid community settings of care, which can be very important to people 
with compromised immune systems.
  I am pleased that this provision was included in the Medicare Part B 
Improvement Act. I urge support of this important bill.
  Mr. TIBERI. Mr. Speaker, I reserve the balance of my time.
  Mr. NEAL. Mr. Speaker, I yield 4 minutes to the gentleman from Texas 
(Mr. Doggett).
  Mr. DOGGETT. Mr. Speaker, as so often happens here, this bill bears a 
somewhat grander title than its contents. Medicare part B certainly 
does need improvement. While I support putting into statute what is 
already administrative practice, extending a demonstration project that 
appears to be working and the other provisions that my colleagues have 
worked on in this bill, I think much more should have happened.
  It is especially ironic that, at the very moment we are considering 
this bill, the United States Senate across the hall is proposing to 
eliminate healthcare coverage for millions of Americans. Certainly, 
this Republican repeal effort does far more harm to far more people 
than we can collectively undo here in the House with this rather modest 
piece of legislation.
  And there is one glaring omission from today's Medicare Improvement 
Act, one subject that the Republican leadership of the House Ways and 
Means Committee fears. It fears not only doing something about this 
problem, it fears about even understanding the extent of the problem, 
and it certainly fears having any public hearings to explore this 
subject. That is the menace that is affecting millions of people across 
this country: pharmaceutical price gouging.
  This bill fails to address any aspect of soaring pharmaceutical costs 
of part B medications. For almost a year, a number of us, House 
Democrats on the Ways and Means Committee, have called on the chairman 
to at least schedule a hearing about all aspects, all categories of 
soaring pharmaceutical prices that not only mean financial ruin for too 
many families, but also burden Medicare and most any type of taxpayer-
financed healthcare initiative.
  Government-approved monopolies for drug manufacturers are being 
exploited by charging the sick and dying whatever they might pay for a 
little more life, for a little more comfort at monopoly prices.
  Under longstanding existing law--it has been there before this 
Congress ever got together--pharmaceutical companies are at least 
required to provide average sales price data on part B Medicare drugs. 
Three years ago, the Office of the Inspector General at the Department 
of Health and Human Services found that at least one-third of the more 
than 200 manufacturers of part B drugs had not submitted any of this 
average sales price data for some of their products, and an additional 
45 manufacturers had not been required to report any data. The 
Inspector General found that inaccuracies in these average sales price 
filings may affect taxpayer-financed Medicare payments.
  Last month, the nonpartisan Medicare Payment Advisory Commission came 
before the House Ways and Means Committee and gave its report on 
Medicare. It noted that this problem on average sales price data 
continues, and that it has not been addressed by Congress, as the 
Inspector General had recommended.
  The Republican majority has refused to do anything about this 
problem. It has blocked an amendment that I offered in committee that 
simply implemented the recommendation of the Inspector General and of 
MedPAC to get that average sales price data and to ensure that all part 
B manufacturers report that data or are penalized at a reasonable 
level. It would simply have ensured compliance with existing law to 
protect program integrity and to protect the taxpayer interest. And you 
can be sure that if the Republicans didn't want to know what the prices 
were, they certainly didn't want to do anything about the soaring 
prices and the impact on American families.
  So I support the bill, but this is a missed opportunity that we 
should have employed to address a critical problem.
  Mr. TIBERI. Mr. Speaker, I yield myself as much time as I may 
consume.
  As the previous speaker said, he supports the bill, which I am 
pleased to hear that, but as the chairman has said, as the ranking 
member has said, this is just the beginning. This is just the 
beginning, and we can't let the perfect be the enemy of the good in 
this piece of legislation because there is very important bipartisan 
legislation that is meaningful to people in a home today somewhere in 
Ohio or Massachusetts where home infusion is really important or 
dialysis is really important.
  I am pleased that the ranking member from Massachusetts has been so 
helpful on this bill, and I reserve the balance of my time.
  Mr. NEAL. Mr. Speaker, I yield myself the balance of my time.
  Mr. Speaker, I want to thank the staff for their hard work on this 
bill, including Amy Hall, Sarah Levin, Melanie Egorin from the 
Democratic staff; Emily Murry and Nick Uehlecke from the Republican 
staff; Jessica Shapiro from the House Legislative Counsel's office; Ira 
Burney, Jennifer Druckman, and Lisa Yen from CMS; and the staff of the 
Congressional Budget Office, Tom Bradley, Rebecca Yip, and Lara 
Robillard. I want to thank them all for their very, very hard work.
  We have this rare opportunity, this rare moment where we have broad 
agreement on this legislation, and I

[[Page 11514]]

hope all Members of the House can find their way to be supportive of 
this legislation, and I hope the path of bipartisanship that we have 
chosen here can serve as a reminder of what we can get done.
  Mr. Speaker, I yield back the balance of my time.
  Mr. TIBERI. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I just say ``ditto'' to the gentleman from Massachusetts 
(Mr. Neal), whom I have a great relationship with, for all the words 
about the staff. In particular, I also want to thank Abby Finn from my 
staff, and Emily Murray and her team; but it has been a pleasure 
working with the gentleman from Massachusetts' team as well, and Mr. 
Levin, the ranking member of the Health Subcommittee.
  Mr. Speaker, this is a good step in the right direction and the first 
step in expanding access to high-quality care and improving efficiency 
and delivery of care so seniors can better receive the care they need 
where they need it, which is so incredibly important. I really 
appreciate the comments of the ranking member.
  And again, I want to remind everybody what the chairman said, that 
this is just the beginning, and hopefully this will be a template to 
much more bipartisan support for the remainder of this year.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BISHOP of Michigan. Mr. Speaker, I rise today in strong support 
of H.R. 3178, the Medicare Part B Improvement Act. This bill would make 
specific improvements to Medicare Part B programs, like protecting 
access to orthotics and prosthetics for Medicare beneficiaries who need 
them.
  In particular, a provision within this bill, spearheaded by 
Representative GT Thompson, Mike Thompson, and myself, would allow 
additional information provided by prosthetists and orthotists--the 
trained clinical experts who evaluate and fit the beneficiary--to be 
considered by Medicare to support documentation of medical necessity 
for orthotics and prosthetics.
  This straightforward, bipartisan bill will improve the quality of 
life of beneficiaries, save jobs of orthotic and prosthetic suppliers, 
and provide a foundation to better meet the healthcare needs of our 
aging constituents.
  I urge my colleagues to join me in supporting H.R. 3178, the Medicare 
Part B improvement Act.
  The SPEAKER pro tempore (Mr. Simpson). The question is on the motion 
offered by the gentleman from Texas (Mr. Brady) that the House suspend 
the rules and pass the bill, H.R. 3178, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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