[Congressional Record (Bound Edition), Volume 158 (2012), Part 13]
[House]
[Pages 17777-17783]
[From the U.S. Government Publishing Office, www.gpo.gov]




MEDICARE IVIG ACCESS AND STRENGTHENING MEDICARE AND REPAYING TAXPAYERS 
                              ACT OF 2012

  Mr. BRADY of Texas. Madam Speaker, I move to suspend the rules and 
pass the bill (H.R. 1845) to provide for a study on issues relating to 
access to intravenous immune globulin (IVIG) for Medicare beneficiaries 
in all care settings and a demonstration project to examine the 
benefits of providing coverage and payment for items and services 
necessary to administer IVIG in the home, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 1845

       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 IVIG Access and 
     Strengthening Medicare and Repaying Taxpayers Act of 2012''.

[[Page 17778]]



                     TITLE I--MEDICARE IVIG ACCESS

     SEC. 101. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.

       (a) Establishment.--The Secretary shall establish and 
     implement a demonstration project under part B of title XVIII 
     of the Social Security Act to evaluate the benefits of 
     providing payment for items and services needed for the in-
     home administration of intravenous immune globin for the 
     treatment of primary immune deficiency diseases.
       (b) Duration and Scope.--
       (1) Duration.--Beginning not later than one year after the 
     date of enactment of this Act, the Secretary shall conduct 
     the demonstration project for a period of 3 years.
       (2) Scope.--The Secretary shall enroll not more than 4,000 
     Medicare beneficiaries who have been diagnosed with primary 
     immunodeficiency disease for participation in the 
     demonstration project. A Medicare beneficiary may participate 
     in the demonstration project on a voluntary basis and may 
     terminate participation at any time.
       (c) Coverage.--Except as otherwise provided in this 
     section, items and services for which payment may be made 
     under the demonstration program shall be treated and covered 
     under part B of title XVIII of the Social Security Act in the 
     same manner as similar items and services covered under such 
     part.
       (d) Payment.--The Secretary shall establish a per visit 
     payment amount for items and services needed for the in-home 
     administration of intravenous immune globin based on the 
     national per visit low-utilization payment amount under the 
     prospective payment system for home health services 
     established under section 1895 of the Social Security Act (42 
     U.S.C. 1395fff).
       (e) Waiver Authority.--The Secretary may waive such 
     requirements of title XVIII of the Social Security Act as may 
     be necessary to carry out the demonstration project.
       (f) Study and Report to Congress.--
       (1) Interim evaluation and report.--Not later than three 
     years after the date of enactment of this Act, the Secretary 
     shall submit to Congress a report that contains an interim 
     evaluation of the impact of the demonstration project on 
     access for Medicare beneficiaries to items and services 
     needed for the in-home administration of intravenous immune 
     globin.
       (2) Final evaluation and report.--Not later than one year 
     after the date of completion of the demonstration project, 
     the Secretary shall submit to Congress a report that contains 
     the following:
       (A) A final evaluation of the impact of the demonstration 
     project on access for Medicare beneficiaries to items and 
     services needed for the in-home administration of intravenous 
     immune globin.
       (B) An analysis of the appropriateness of implementing a 
     new methodology for payment for intravenous immune globulins 
     in all care settings under part B of title XVIII of the 
     Social Security Act (42 U.S.C. 1395k et seq.).
       (C) An update to the report entitled ``Analysis of Supply, 
     Distribution, Demand, and Access Issues Associated with 
     Immune Globulin Intravenous (IGIV)'', issued in February 2007 
     by the Office of the Assistant Secretary for Planning and 
     Evaluation of the Department of Health and Human Services.
       (g) Funding.--There shall be made available to the 
     Secretary to carry out the demonstration project not more 
     than $45,000,000 from the Federal Supplementary Medical 
     Insurance Trust Fund under section 1841 of the Social 
     Security Act (42 U.S.C. 1395t).
       (h) Definitions.--In this section:
       (1) Demonstration project.--The term ``demonstration 
     project'' means the demonstration project conducted under 
     this section.
       (2) Medicare beneficiary.--The term ``Medicare 
     beneficiary'' means an individual who is enrolled for 
     benefits under part B of title XVIII of the Social Security 
     Act.
       (3) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.

         TITLE II--STRENGTHENING MEDICARE SECONDARY PAYER RULES

     SEC. 201. DETERMINATION OF REIMBURSEMENT AMOUNT THROUGH CMS 
                   WEBSITE TO IMPROVE PROGRAM EFFICIENCY.

       Section 1862(b)(2)(B) of the Social Security Act (42 U.S.C. 
     1395y(b)(2)(B)) is amended by adding at the end the following 
     new clause:
       ``(vii) Use of website to determine final conditional 
     reimbursement amount.--

       ``(I) Notice to secretary of expected date of a settlement, 
     judgment, etc.--In the case of a payment made by the 
     Secretary pursuant to clause (i) for items and services 
     provided to the claimant, the claimant or applicable plan (as 
     defined in paragraph (8)(F)) may at any time beginning 120 
     days before the reasonably expected date of a settlement, 
     judgment, award, or other payment, notify the Secretary that 
     a payment is reasonably expected and the expected date of 
     such payment.
       ``(II) Secretarial providing access to claims information 
     through a website.--The Secretary shall maintain and make 
     available to individuals to whom items and services are 
     furnished under this title (and to authorized family or other 
     representatives recognized under regulations and to an 
     applicable plan which has obtained the consent of the 
     individual) access to information on the claims for such 
     items and services (including payment amounts for such 
     claims), including those claims that relate to a potential 
     settlement, judgment, award, or other payment. Such access 
     shall be provided to an individual, representative, or plan 
     through a website that requires a password to gain access to 
     the information. The Secretary shall update the information 
     on claims and payments on such website in as timely a manner 
     as possible but not later than 15 days after the date that 
     payment is made. Information related to claims and payments 
     subject to the notice under subclause (I) shall be maintained 
     and made available consistent with the following:

       ``(aa) The information shall be as complete as possible and 
     shall include provider or supplier name, diagnosis codes (if 
     any), dates of service, and conditional payment amounts.
       ``(bb) The information accurately identifies those claims 
     and payments that are related to a potential settlement, 
     judgment, award, or other payment to which the provisions of 
     this subsection apply.
       ``(cc) The website provides a method for the receipt of 
     secure electronic communications with the individual, 
     representative, or plan involved.
       ``(dd) The website provides that information is transmitted 
     from the website in a form that includes an official time and 
     date that the information is transmitted.
       ``(ee) The website shall permit the individual, 
     representative, or plan to download a statement of 
     reimbursement amounts (in this clause referred to as a 
     `statement of reimbursement amount') on payments for claims 
     under this title relating to a potential settlement, 
     judgment, award, or other payment.

       ``(III) Use of timely web download as basis for final 
     conditional amount.--If an individual (or other claimant or 
     applicable plan with the consent of the individual) obtains a 
     statement of reimbursement amount from the website during the 
     protected period as defined in subclause (V) and the related 
     settlement, judgment, award or other payment is made during 
     such period, then the last statement of reimbursement amount 
     that is downloaded during such period and within 3 business 
     days before the date of the settlement, judgment, award, or 
     other payment shall constitute the final conditional amount 
     subject to recovery under clause (ii) related to such 
     settlement, judgment, award, or other payment.
       ``(IV) Resolution of discrepancies.--If the individual (or 
     authorized representative) believes there is a discrepancy 
     with the statement of reimbursement amount, the Secretary 
     shall provide a timely process to resolve the discrepancy. 
     Under such process the individual (or representative) must 
     provide documentation explaining the discrepancy and a 
     proposal to resolve such discrepancy. Within 11 business days 
     after the date of receipt of such documentation, the 
     Secretary shall determine whether there is a reasonable basis 
     to include or remove claims on the statement of 
     reimbursement. If the Secretary does not make such 
     determination within the 11 business-day period, then the 
     proposal to resolve the discrepancy shall be accepted. If the 
     Secretary determines within such period that there is not a 
     reasonable basis to include or remove claims on the statement 
     of reimbursement, the proposal shall be rejected. If the 
     Secretary determines within such period that there is a 
     reasonable basis to conclude there is a discrepancy, the 
     Secretary must respond in a timely manner by agreeing to the 
     proposal to resolve the discrepancy or by providing 
     documentation showing with good cause why the Secretary is 
     not agreeing to such proposal and establishing an alternate 
     discrepancy resolution. In no case shall the process under 
     this subclause be treated as an appeals process or as 
     establishing a right of appeal for a statement of 
     reimbursement amount and there shall be no administrative or 
     judicial review of the Secretary's determinations under this 
     subclause.
       ``(V) Protected period.--In subclause (III), the term 
     `protected period' means, with respect to a settlement, 
     judgment, award or other payment relating to an injury or 
     incident, the portion (if any) of the period beginning on the 
     date of notice under subclause (I) with respect to such 
     settlement, judgment, award, or other payment that is after 
     the end of a Secretarial response period beginning on the 
     date of such notice to the Secretary. Such Secretarial 
     response period shall be a period of 65 days, except that 
     such period may be extended by the Secretary for a period of 
     an additional 30 days if the Secretary determines that 
     additional time is required to address claims for which 
     payment has been made. Such Secretarial response period shall 
     be extended and shall not include any days for any part of 
     which the Secretary determines (in accordance with 
     regulations) that there was a failure in the claims and 
     payment posting system and the failure was justified due to 
     exceptional circumstances (as defined in such regulations). 
     Such regulations shall define exceptional circumstances in a 
     manner so that not more than 1 percent of the repayment 
     obligations under this subclause would qualify as exceptional 
     circumstances.
       ``(VI) Effective date.--The Secretary shall promulgate 
     final regulations to carry

[[Page 17779]]

     out this clause not later than 9 months after the date of the 
     enactment of this clause.
       ``(VII) Website including successor technology.--In this 
     clause, the term `website' includes any successor technology.

       ``(viii) Right of appeal for secondary payer determinations 
     relating to liability insurance (including self-insurance), 
     no fault insurance, and workers' compensation laws and 
     plans.--The Secretary shall promulgate regulations 
     establishing a right of appeal and appeals process, with 
     respect to any determination under this subsection for a 
     payment made under this title for an item or service for 
     which the Secretary is seeking to recover conditional 
     payments from an applicable plan (as defined in paragraph 
     (8)(F)) that is a primary plan under subsection (A)(ii), 
     under which the applicable plan involved, or an attorney, 
     agent, or third party administrator on behalf of such plan, 
     may appeal such determination. The individual furnished such 
     an item or service shall be notified of the plan's intent to 
     appeal such determination''.

     SEC. 202. FISCAL EFFICIENCY AND REVENUE NEUTRALITY.

       (a) In General.--Section 1862(b) of the Social Security Act 
     (42 U.S.C. 1395y(b)) is amended--
       (1) in paragraph (2)(B)(ii), by striking ``A primary plan'' 
     and inserting ``Subject to paragraph (9), a primary plan''; 
     and
       (2) by adding at the end the following new paragraph:
       ``(9) Exception.--
       ``(A) In general.--Clause (ii) of paragraph (2)(B) and any 
     reporting required by paragraph (8) shall not apply with 
     respect to any settlement, judgment, award, or other payment 
     by an applicable plan arising from liability insurance 
     (including self-insurance) and from alleged physical trauma-
     based incidents (excluding alleged ingestion, implantation, 
     or exposure cases) constituting a total payment obligation to 
     a claimant of not more than the single threshold amount 
     calculated by the Secretary under subparagraph (B) for the 
     year involved.
       ``(B) Annual computation of threshold.--
       ``(i) In general.--Not later than November 15 before each 
     year, the Secretary shall calculate and publish a single 
     threshold amount for settlements, judgments, awards, or other 
     payments for obligations arising from liability insurance 
     (including self-insurance) and for alleged physical trauma-
     based incidents (excluding alleged ingestion, implantation, 
     or exposure cases) subject to this section for that year. The 
     annual single threshold amount for a year shall be set such 
     that the estimated average amount to be credited to the 
     Medicare trust funds of collections of conditional payments 
     from such settlements, judgments, awards, or other payments 
     arising from liability insurance (including self-insurance) 
     and for such alleged incidents subject to this section shall 
     equal the estimated cost of collection incurred by the United 
     States (including payments made to contractors) for a 
     conditional payment arising from liability insurance 
     (including self-insurance) and for such alleged incidents 
     subject to this section for the year. At the time of 
     calculating, but before publishing, the single threshold 
     amount for a year, the Secretary shall inform, and seek 
     review of, the Comptroller General of the United States with 
     regard to such amount.
       ``(ii) Publication.--The Secretary shall include, as part 
     of such publication for a year--

       ``(I) the estimated cost of collection incurred by the 
     United States (including payments made to contractors) for a 
     conditional payment arising from liability insurance 
     (including self-insurance) and for such alleged incidents; 
     and
       ``(II) a summary of the methodology and data used by the 
     Secretary in computing such threshold amount and such cost of 
     collection.

       ``(C) Exclusion of ongoing expenses.--For purposes of this 
     paragraph and with respect to a settlement, judgment, award, 
     or other payment not otherwise addressed in clause (ii) of 
     paragraph (2)(B) that includes ongoing responsibility for 
     medical payments (excluding settlements, judgments, awards, 
     or other payments made by a workers' compensation law or plan 
     or no fault insurance), the amount utilized for calculation 
     of the threshold described in subparagraph (A) shall include 
     only the cumulative value of the medical payments made under 
     this title.
       ``(D) Report to congress.--Not later than November 15 
     before each year, the Secretary shall submit to the Congress 
     a report on the single threshold amount for settlements, 
     judgments, awards, or other payments for conditional payment 
     obligations arising from liability insurance (including self-
     insurance) and alleged incidents described in subparagraph 
     (A) for that year and on the establishment and application of 
     similar thresholds for such payments for conditional payment 
     obligations arising from worker compensation cases and from 
     no fault insurance cases subject to this section for the 
     year. For each such report, the Secretary shall--
       ``(i) calculate the threshold amount by using the 
     methodology applicable to certain liability claims described 
     in subparagraph (B); and
       ``(ii) include a summary of the methodology and data used 
     in calculating each threshold amount and the amount of 
     estimated savings under this title achieved by the Secretary 
     implementing each such threshold.''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall apply to years beginning with 2014.

     SEC. 203. REPORTING REQUIREMENT.

       Section 1862(b)(8) of the Social Security Act (42 U.S.C. 
     1395y(b)(8)) is amended--
       (1) in the first sentence of subparagraph (E)(i), by 
     striking ``shall be subject'' and all that follows through 
     the end of the sentence and inserting the following: ``may be 
     subject to a civil money penalty of up to $1,000 for each day 
     of noncompliance with respect to each claimant.''; and
       (2) by adding at the end the following new subparagraph:
       ``(I) Regulations.--Not later than 60 days after the date 
     of the enactment of this subparagraph, the Secretary shall 
     publish a notice in the Federal Register soliciting 
     proposals, which will be accepted during a 60-day period, for 
     the specification of practices for which sanctions will and 
     will not be imposed under subparagraph (E), including not 
     imposing sanctions for good faith efforts to identify a 
     beneficiary pursuant to this paragraph under an applicable 
     entity responsible for reporting information. After 
     considering the proposals so submitted, the Secretary, in 
     consultation with the Attorney General, shall publish in the 
     Federal Register, including a 60-day period for comment, 
     proposed specified practices for which such sanctions will 
     and will not be imposed. After considering any public 
     comments received during such period, the Secretary shall 
     issue final rules specifying such practices.''.

     SEC. 204. USE OF SOCIAL SECURITY NUMBERS AND OTHER 
                   IDENTIFYING INFORMATION IN REPORTING.

       Section 1862(b)(8)(B) of the Social Security Act (42 U.S.C. 
     1395y(b)(8)(B)) is amended by adding at the end (after and 
     below clause (ii)) the following:

     ``Not later than 18 months after the date of enactment of 
     this sentence, the Secretary shall modify the reporting 
     requirements under this paragraph so that an applicable plan 
     in complying with such requirements is permitted but not 
     required to access or report to the Secretary beneficiary 
     social security account numbers or health identification 
     claim numbers, except that the deadline for such modification 
     shall be extended by one or more periods (specified by the 
     Secretary) of up to 1 year each if the Secretary notifies the 
     committees of jurisdiction of the House of Representatives 
     and of the Senate that the prior deadline for such 
     modification, without such extension, threatens patient 
     privacy or the integrity of the secondary payer program under 
     this subsection. Any such deadline extension notice shall 
     include information on the progress being made in 
     implementing such modification and the anticipated 
     implementation date for such modification.''.

     SEC. 205. STATUTE OF LIMITATIONS.

       (a) In General.--Section 1862(b)(2)(B)(iii) of the Social 
     Security Act (42 U.S.C. 1395y(b)(2)(B)(iii)) is amended by 
     adding at the end the following new sentence: ``An action may 
     not be brought by the United States under this clause with 
     respect to payment owed unless the complaint is filed not 
     later than 3 years after the date of the receipt of notice of 
     a settlement, judgment, award, or other payment made pursuant 
     to paragraph (8) relating to such payment owed.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply with respect to actions brought and penalties 
     sought on or after 6 months after the date of the enactment 
     of this Act.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Texas (Mr. Brady) and the gentleman from Wisconsin (Mr. Kind) 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 in which to revise and extend their 
remarks and to include extraneous material on the subject of the bill 
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.
  I, too, want to add my thanks and appreciation to my classmate on her 
years of dedication and stellar service to the United States of America 
on behalf of your wonderful State. Thank you.
  Some of you may remember David, the little boy in the bubble. He was 
a constituent from Shenandoah, Texas, who passed away at the age of 12 
after

[[Page 17780]]

living many years of his life in a sterile environment at the Texas 
Children's Hospital in Houston, Texas. His mom, Carol Ann Demeret, is a 
champion for David and for other patients who were born with 
immunodeficiency disease. Carol Ann is a friend and a constituent, and 
has worked so hard to help those patients impacted with that disease. 
For years now, Carol Ann and I and many others have been fighting to 
change the law that could help patients like David.
  Intravenous immune globulin, or IVIG therapy, is a vital step for 
treating patients with certain life-threatening diseases. These are 
patients for whom virtually every trip outside is potentially deadly. 
For the 250,000 Americans with primary immunodeficiency disease, there 
is no place more dangerous than going to a hospital for treatment. This 
is why home IVIG treatment actually prevents people being exposed to 
common illnesses that may make you and I miserable for a day or two, 
but could be deadly for patients with suppressed immune systems.
  Regular access to IVIG therapy means a better quality of life, less 
disability, and potentially the difference between life and death. 
Unfortunately, today current law excludes from Medicare coverage the 
items and services necessary to administer IVIG therapy in the home, 
where doctors tell us patients with compromised immune systems can 
benefit the most.
  The Medicare IVIG Access Act requires the Centers for Medicare and 
Medicaid Services to do a couple of things. It establishes a 3-year 
demonstration project to cover these items and services necessary to do 
this therapy in the home. It evaluates the impact of the demonstration 
project on access for these Medicare beneficiaries, analyzes the 
appropriateness of implementing a new methodology for IVIG payment in 
all care settings under Medicare part B, and updates a previous report 
on this by the Assistant Secretary for Planning and Evaluation.
  It's my intent that the required study consider the impact of lag 
times with respect to data used to determine the average sales price 
and make recommendations to reduce the lag time to ensure more accurate 
pricing for IVIG, and to report whether home infusion saves the 
Medicare program tax dollars by improving access to all care settings.
  The Medicare Payment Advisory Committee recently looked at home 
infusion, including the access problem for Medicare beneficiaries with 
PIDD.
  The June MedPAC report reported that a targeted expansion of home 
infusion coverage focusing on certain drugs would have more likelihood 
of savings.
  Drugs with a narrow indication and precise diagnostic criteria like 
IVIG for PIDD are less likely to have a woodwork effect than drugs with 
broad uses or imprecise diagnostic criteria. MedPAC's report also 
highlighted that fixing the part B home infusion therapy for 
beneficiaries with PIDD may save money because some of the other 
covered therapies for these patients are more expensive.
  I expect, Madam Speaker, that the study required by this bill will 
give us more information about potential savings from giving people 
access to the right kind of care, reducing their exposure to germs in 
other settings, and increased compliance with prescribed therapy.
  There may be a lot of division and partisanship in Washington right 
now, but not about this bill. I would like to thank my esteemed 
colleague, Representative Doris Matsui of California, for her 
leadership and tremendous hard work on this important bill. We have 
here today a solid, bipartisan bill, and both the House and Senate join 
together in support of Medicare IVIG access.
  Madam Speaker, I will include in the Record an exchange of letters 
between the Ways and Means Committee and Energy and Commerce Committee 
related to this bill, and I reserve the balance of my time.

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                Washington, DC, December 11, 2012.
     Hon. Dave Camp,
     Chairman, Committee on Ways and Means, Washington, DC.
       Dear Chairman Camp: I am writing concerning H.R. 1845, the 
     ``Medicare IVIG Access Act.'' I wanted to notify you that the 
     Committee on Energy and Commerce will forgo action on the 
     bill so that it may proceed expeditiously to the House floor 
     for consideration.
       This is done with the understanding that the Committee on 
     Energy and Commerce is not waiving any of its jurisdiction, 
     and the Committee will not be prejudiced with respect to the 
     appointment of conferees or its jurisdictional prerogatives 
     on this or similar legislation.
       I would appreciate a response confirming this understanding 
     and ask that a copy of our exchange of letters on this matter 
     be included in the Congressional Record during consideration 
     of H.R. 1845 on the House floor.
           Sincerely,
                                                       Fred Upton,
     Chairman.
                                  ____

                                         House of Representatives,


                                  Committee on Ways and Means,

                                Washington, DC, December 18, 2012.
     Hon. Fred Upton,
     Chairman, Committee on Energy and Commerce, Washington,
       Dear Chairman Upton, Thank you for your letter regarding 
     H.R. 1845, the ``Medicare IVIG Access and Strengthening 
     Medicare and Repaying Taxpayers Act of 2012,'' as amended, 
     which is expected to be considered on the floor this week.
       I appreciate your willingness to forgo action on H.R. 1845. 
     I agree that your decision should not prejudice the Committee 
     on Energy and Commerce with respect to the appointment of 
     conferees or its jurisdictional prerogatives on this or 
     similar legislation.
       I will include a copy of your letter and this response in 
     the Congressional Record during consideration of H.R. 1845 on 
     the House floor.
           Sincerely,
                                                        Dave Camp,
                                                         Chairman.

  Mr. KIND. Madam Speaker, I yield myself such time as I may consume.
  Madam Speaker, I rise in strong support of H.R. 1845. It's a 
combination of two strong, bipartisan commonsense bills before the 
House today. I want to thank the gentleman on the Ways and Means 
Committee, Mr. Brady, for his support of this important legislation.
  As one of the coauthors of the SMART Act, one of the bills that have 
been combined today, with Representative Tim Murphy, and as an original 
cosponsor of the Medicare IVIG Access Act, I'm glad these two 
bipartisan bills have been combined and brought to the floor for 
consideration and hopefully passage later today.
  The SMART Act had 139 bipartisan cosponsors; the Medicare IVIG Access 
Act, with 65 bipartisan cosponsors, are perfect examples of, at times, 
Democrats and Republicans joining forces and getting something done 
around this place. And hopefully that spirit will continue in the days 
to come with the difficult decisions that face this body.
  I would like to thank my good friend Tim Murphy for his leadership 
and hard work in moving the SMART Act through the Energy and Commerce 
Committee. I'd also like to recognize the extraordinary, broad 
stakeholder coalition that has worked so hard to help get the SMART Act 
on the floor today, particularly the American Association For Justice 
and the MARC Coalition.
  Finally, I want to thank Representative Brady and Doris Matsui for 
their tireless efforts on behalf of the Medicare IVIG Access Act. Their 
legislation is a step toward ensuring all seniors with primary 
immunodeficiency diseases are able to access life-saving IVIG drugs in 
their own home.
  But let me just take a few minutes to discuss the need for the SMART 
Act. The SMART Act reforms the badly broken Medicare secondary payer 
system. For background, the Medicare secondary payer system requires 
Medicare to recoup the cost of hospital and doctor bills for a senior 
if her injuries are the responsibility of a private insurer or some 
other third party. So far so good. Making sure Medicare doesn't pay for 
injuries caused by another third party is good policy to help keep 
Medicare solvent.
  The problem is that under the current system, seniors and parties 
that want to settle a claim often cannot determine how much they owe 
Medicare. That often results in the settlements collapsing. The result 
is that seniors are denied settlements to compensate for their 
injuries, and the Medicare trust fund is never reimbursed. That's

[[Page 17781]]

bad for seniors, and it's bad for the Medicare program. We're talking 
about cases where seniors are trying to give money back to the 
government and the government simply won't say how much they owe it. 
It's outrageous that seniors can't even give money back to Medicare 
that the government is owed because the system is broken down.
  At a time when Congress is considering cuts to the Medicare benefits 
and provider payments, we need to at least make sure that Medicare is 
getting the money seniors want to send it.
  The SMART Act will improve the Medicare secondary payer system by 
making the government work more efficiently, reducing unnecessary 
burdens and waste, and speeding the repayment of amounts owed to the 
Medicare trust fund. The best way to demonstrate the need for the 
legislation is with a few examples of the current system's unfairness 
and outright absurdity.

                              {time}  1340

  I have a handful of demand letters here sent by CMS to seniors asking 
to be repaid $1.59, or $2.81, or $4.82, or even $36.75. Those amounts 
CMS has sought to recoup from seniors is far less than the amount it 
actually costs CMS to pursue these claims. That's penny wise and a 
pound foolish.
  The SMART Act makes sure CMS is only pursuing Medicare secondary 
payment claims that will recoup at least the cost that it takes CMS to 
pursue these claims. That's commonsense reform.
  This bill makes financial sense for Medicare, but it will also make a 
meaningful difference for seniors who are awaiting settlements that are 
held up by Medicare's process today.
  In fact, I heard the story of one gentleman who fell on a retailer's 
handicapped ramp while using a walker. Now, Mr. Law cut his left hand; 
he hit his head on the fence alongside the ramp. He and the retailer 
discussed the medical charges, and they agreed to settle for $2,000.
  It took 18 months and eight written exchanges with CMS to resolve 
this simple MSP claim, which delayed settlement of the claim by the 
same 18 months. Plus, Mr. Law actually passed away during the extended 
timeframe.
  We can do better for seniors. We can get Medicare the money it's owed 
a lot faster. This legislation would accomplish that.
  These are just a few of the examples of why the SMART Act is needed. 
The toll this broken system takes on seniors and the burden it imposes 
on businesses is unacceptable.
  I urge my colleagues to vote for H.R. 1845 to support this 
commonsense reform, including the IVIG program.
  And, Madam Speaker, since this may be the last time I'll have a 
chance to address you in the chair, I too want to echo the sentiments 
of so many of our colleagues, to congratulate you on such a 
distinguished career here in the House.
  You did well in representing your constituents back home in Missouri. 
We'll miss you as a colleague, someone who tried hard to work on 
finding bipartisan, commonsense solutions to the challenges facing our 
Nation. And, of course, we wish you all the best in your future 
endeavors.
  I reserve the balance of my time.
  Mr. BRADY of Texas. At this time, I yield 2 minutes to the chairman 
of the Health Subcommittee, a longtime fighter for patients and those 
on Medicare, the gentleman from California (Mr. Herger).
  Mr. HERGER. I thank my friend from Texas.
  Madam Speaker, I rise today in strong support of H.R. 1845, as 
amended, the Medicare IVIG Access and Strengthening Medicare and 
Repaying Taxpayers Act of 2012.
  This legislation would create a 3-year demonstration project to 
provide up to 4,000 Medicare beneficiaries suffering from primary 
immunodeficiency diseases with in-home coverage of IVIG. Medicare 
beneficiaries with PIDD need the biologic IVIG to boost their immune 
system so they can fight off infection and maintain a high quality of 
life.
  Medicare currently offers comprehensive coverage of IVIG treatments 
in the physician's office and hospital setting, but not when IVIG is 
administered in the home. This flawed payment policy encourages 
Medicare beneficiaries to receive care in the most costly settings.
  Under this demonstration project, Medicare part B would cover the 
home administration costs, including the trained medical professional 
who administers the biologic, allowing up to 4,000 beneficiaries with 
PIDD to receive IVIG treatments in their home. Importantly, 
beneficiaries who receive IVIG in their home can avoid the risk of 
infection inherent in alternative treatment settings.
  The HHS Secretary would be required to issue a report to Congress 
detailing the impact this demonstration project had on beneficiary 
access to care, and whether or not CMS should permanently change its 
IVIG coverage policy. According to CBO, the costs of this one-time 
demonstration are fully offset by permanently reforming Medicare's 
secondary-payer rules as detailed in the SMART Act.
  The SMART Act will help ensure that taxpayers will not be stuck with 
a Medicare bill for incidents caused when another party is liable or 
negligent. The SMART Act also makes important changes so that the 
arcane Medicare rules would no longer be an impediment for parties 
resolving their differences and reaching settlement.
  The SPEAKER pro tempore. The time of the gentleman has expired.
  Mr. BRADY of Texas. Madam Speaker, I yield another minute to the 
gentleman from California.
  Mr. HERGER. Madam Speaker, we need to protect the Medicare trust 
funds, and we need to have an efficient, consistent, and clear process 
to resolve these claims; and the SMART Act does exactly that.
  I urge my colleagues to join me in support of this important 
legislation.
  Mr. KIND. Madam Speaker, I want to thank my good friend, the 
gentleman from California, for his support of H.R. 1845, in particular, 
the SMART Act, and congratulate him, as well, on his distinguished 
career since he will be retiring at the end of this session of Congress 
as well.
  At this time I yield as much time as she may consume to the 
gentlewoman from California (Ms. Matsui), the principal author of the 
Medicare IVIG Act.
  Ms. MATSUI. I'd like to thank my colleague for yielding.
  I also want to say, Madam Speaker, thank you for your many wonderful 
years of service and our friendship. We'll miss you in this Chamber, 
and we wish you well.
  Madam Speaker, I rise in strong support of H.R. 1845, the Medicare 
IVIG Access Act. I'd like to thank Congressman Brady for his hard work 
and his leadership on this legislation, as well as Congressman Kind for 
the leadership on the SMART Act provisions of this important 
legislation.
  Primary Immunodeficiency Diseases or, as we call it, PIDDs, is a 
group of diseases that cause a person's immune system to be unable to 
function properly. Unlike most of us who are able to fight common 
infectious diseases, patients with untreated PIDD can become seriously 
ill from a simple cold virus or even a cut on their arm.
  Patients with PIDD are generally treated with intravenous 
immunoglobulin, or IVIG, a complex drug that provides them a temporary 
immune system. Every 3-4 weeks, patients receive an IV treatment for 
about 2-4 hours per treatment. To maintain a healthy immune system, 
they must have this treatment for the rest of their lives.
  People with commercial insurance typically receive care in any of 
three settings: hospital outpatient departments; a physician's office; 
or at home, administered by a nurse. For many patients, receiving their 
care at home is optimal, as it greatly reduces the risk of infection.
  However, for Medicare beneficiaries with PIDD, the program pays for 
home infusion of IVIG but does not cover nursing services and supplies. 
As you can imagine, a 74-year-old Medicare recipient on a fixed income 
is not capable of paying the several hundred dollars a month necessary 
for the nurse to provide IVIG infusions in their homes. As

[[Page 17782]]

a result, many patients are forced to receive their treatment in a 
hospital setting, oftentimes increasing the likelihood of infection, 
pneumonia, and an expensive stay in a hospital billed to Medicare.
  Madam Speaker, this does not make sense for the patient or for 
Medicare, and that's why Congressman Brady and I introduced the 
Medicare IVIG Access Act.
  Madam Speaker, this legislation is budget-neutral and fully paid for. 
H.R. 1845 creates a 3-year demonstration project capped at 4,000 
patients, in which the nursing services and supplies associated with 
home infusion of IVIG will be covered for Medicare beneficiaries with 
PIDD.
  I believe that this project will mirror the results of studies of 
patients with commercial insurance that found increased compliance, 
fewer infections and overall savings for patients infused at home 
versus the hospital.
  Madam Speaker, patients with rare genetic diseases should not see 
their access to care diminish when they become eligible for Medicare. 
H.R. 1845 fixes the gap in Medicare coverage that unfairly restricts 
patients' access to IVIG and disrupts their continuity of care.
  I strongly encourage my colleagues to vote for this critically 
important legislation.

                              {time}  1350

  Mr. BRADY of Texas. Madam Speaker, I am pleased to yield 5 minutes to 
the lead author and champion of the SMART Act, one of our health care 
leaders, Mr. Murphy of Pennsylvania.
  Mr. MURPHY of Pennsylvania. I thank the gentleman.
  Madam Speaker, may I add my accolades to your work for the people of 
Missouri, particularly my ancestors who founded Murphy's Settlement, 
now Farmington, in your district. You've done them well.
  Four years ago, Lorraine Babich of Washington County, Pennsylvania, 
then age 73, suffered injuries so severe from a car accident that she 
will never fully recover. After the accident, Lorraine underwent a very 
difficult surgery. She was transferred to a rehabilitation facility, 
where she contracted Methicillin-resistant Staphylococcus Aureus, 
otherwise known as MRSA. Sadly, Lorraine's condition has worsened. She 
now suffers from dementia and must receive 24/7 care at a nursing home. 
The physical pain in Lorraine's life is multiplied by the emotional 
pain of recent years. A year after the accident, Lorraine lost her 
husband; then, last year, her only child passed away.
  Lorraine's story is heartbreaking and tragic, and it's depressing to 
learn Medicare is working against Lorraine's interests. In the fall of 
2010, Lorraine's family and the automobile insurer for the other driver 
in the accident reached a monetary settlement. The insurer agreed to 
pay Lorraine's medical bills, and Lorraine would also collect damages. 
First, Lorraine's health insurer--Medicare--had to be repaid, but the 
Centers for Medicare and Medicaid Services won't tell Lorraine or the 
auto insurer how much is owed to the Medicare trust fund. The insurance 
company wants to reimburse Medicare and provide Lorraine with a 
settlement, but CMS's complicated bureaucracy is standing in the way.
  There are thousands of cases just like Lorraine's in congressional 
districts across the country. But we now have a chance to fix this 
problem and make sure Lorraine and her family receive what they are 
rightfully owed by passing H.R. 1845, which includes a bipartisan bill 
I introduced with Congressman Ron Kind.
  Our bill, the Strengthening Medicare and Repaying Taxpayers Act, or 
the SMART Act, will recoup billions of dollars owed by insurance 
companies to the Medicare trust fund quickly and eliminate waste within 
CMS. The SMART Act, which has nearly 140 bipartisan cosponsors and the 
support of trial lawyers, patient advocates, defense attorneys, and the 
U.S. Chamber of Commerce, requires that Medicare provide settling 
parties with accurate information about the total costs of medical 
bills when the parties announce a settlement is near.
  The Congressional Budget Office has looked at our bill and found it 
will save billions in Medicare. The current Medicare Secondary Payer 
bureaucracy is causing seniors to have their Social Security checks 
garnished and their Medicare coverage denied, through no fault of their 
own. Our bill fixes these issues and ensures bureaucracy does not stand 
in the way of a settlement.
  Right now, insurers are walking away from settlements because of the 
flaws in the Medicare Secondary Payer statute. When those settlements 
break down, seniors get nothing and the taxpayers are not repaid. By 
enacting this legislation, Congress can help Lorraine and thousands of 
senior citizens who are needlessly suffering because Medicare isn't 
operating effectively and efficiently.
  I want to thank Chairmen Upton and Camp, Ranking Members Waxman and 
Levin, and Congressman Kind for their support on this legislation. I 
want to extend a special thanks to their respective staffs for their 
hard work, particularly Robert Horne and Brad Grantz. Without them, 
this legislation wouldn't be moving forward.
  This is good government and saves taxpayers' money. I urge its 
adoption.
  Mr. KIND. I yield such time as he may consume to my very good friend, 
the gentleman from New Jersey, one of the leaders in the Energy and 
Commerce Committee, Mr. Pallone.
  Mr. PALLONE. I want to thank the gentleman from Wisconsin.
  Madam Speaker, I rise to lend my support to H.R. 1845, as amended. 
This bill combines two pieces of legislation: H.R. 1845, which provides 
a demonstration for the coverage of home infusion of intravenous immune 
globulin, or IVIG, and H.R. 1063, which makes improvements to the 
Medicare Secondary Payer process, or MSP. However, I would like to note 
my concerns about the process.
  Our committee acted on H.R. 1063, and I commend the chairman for his 
efforts to ensure it was a bipartisan product, but we did not act on 
the IVIG legislation, which is every bit as important to our Members as 
the MSP. So it's my hope that in the future we can avoid situations 
like this.
  The Medicare Secondary Payer provisions of this bill will reduce the 
burdens of the secondary payer process for beneficiaries and other 
stakeholders. Most importantly, the legislation will do so in a way 
that ensures that we're also protecting taxpayer dollars and the 
Medicare trust fund. I do worry, however, that the MSP bill does not 
include administrative funding for the Centers for Medicare and 
Medicaid Services, or CMS, to implement these new changes.
  One of the primary complaints I hear about MSP is that stakeholders 
are currently frustrated because the process does not move fast enough. 
But here we are, legislating new responsibilities on top of an already 
slow process--with no funding. This will simply burden the agency and 
make it more difficult to get to resolution on secondary payer cases in 
a timely fashion. So I hope that at some future date we can provide a 
reasonable sum to the agency to allow them to be better equipped to 
speed this process along.
  One additional point on MSP: the new process we've established for 
resolving disputes of claims posted on the Web portal is not intended 
to supplant the ordinary appeals process for MSP activities. I believe 
that is clear in the language, but I want to note that there should be 
no ambiguity. This bill does not supplant existing appeals rights.
  In addition to MSP changes, this bill also provides for a 3-year 
demonstration related to IVIG. IVIG is a blood-derived treatment that 
helps strengthen the immune systems of immune-deficient patients and 
prevents paralysis in some autoimmune diseases and neuropathies. 
Currently, Medicare beneficiaries may receive home infusion of IVIG as 
a part B benefit; however, the equipment, nursing services, and 
supplies necessary for the home infusion are not reimbursed.
  Congresswoman Matsui has been a clear leader on this issue and it's 
to her credit that it's included in this package today. She's worked so 
tirelessly on this IVIG issue, and I'm hopeful that this demonstration 
project she

[[Page 17783]]

has championed will both save money for the Medicare program and 
improve access to needed services for this vulnerable population. I 
thank her for her leadership on behalf of these patients.
  I also want to thank Chairman Upton for working on these two issues 
with us, and I look forward to the next Congress, where, hopefully, 
we'll find additional areas of common ground to work on.
  Mr. KIND. I have no further speakers. I encourage my colleagues to 
support H.R. 1845, and I yield back the balance of my time.
  Mr. BRADY of Texas. I yield myself such time as I may consume.
  In closing, I want to thank my counterpart, Doris Matsui, for her 
great work on this issue. I so appreciate the leadership and 
partnership of Mr. Kind and Mr. Murphy in combining these two important 
health care bills in order to both provide safer, more affordable 
access to care for those with compromised immune deficiencies, as well 
as finding ways to save money with the important Medicare program and 
the SMART Act.
  I want to thank Andrew Wankum of my staff for his excellent work on 
this bill, Dan Elling, staff director of the Ways and Means 
Subcommittee on Health, as well as Jennifer Safavian for her leadership 
on the Ways and Means Committee. But I especially want to thank my 
constituent friend, Carol Ann Demaret, the mom of David, for her 
decades of hard work on behalf of these patients. And I appreciate so 
much Marcia Boyle, the founder of the Immune Deficiency Foundation, and 
all those patients who for years have come up here asking for this help 
and change.
  Today, this Congress, Republicans and Democrats alike, join together 
in providing that help and that access. I urge support for this bill 
and yield back the balance of my time.
  Mr. WAXMAN. Madam Speaker, I am pleased that we are bringing this 
bill to the floor today. This bill combines two pieces of legislation, 
H.R. 1845 which provides a demonstration for the coverage of home 
infusion of intra venous immune globulin (IVIG) and H.R. 1063, which 
makes improvements to the Medicare Secondary Payer process.
  H.R. 1063 was developed and reported by the Energy and Commerce 
Committee as a bipartisan effort. I commend Chairman Upton's 
willingness to work with us to achieve a solution. I believe we have a 
good balance assembling this package of improvements to the current 
process.
  Under current law, Medicare is a secondary payer to certain group 
health plans and non-group health plans regardless of state law or plan 
provisions. These plans include auto or other liability insurance, no-
fault insurance, and workers' compensation plans. But even though it is 
legally a secondary payer, it pays medical claims for Medicare 
beneficiaries--even if they may have other entities with a legal 
responsibility--and then recovers its expenditures so seniors and 
persons with disabilities are able to get the services they need. Then 
the appropriate claims are settled after the fact. The goal of the 
Medicare Secondary Payer bill is to reduce the burdens of the secondary 
payer process for beneficiaries and other stakeholders and help to have 
timely settlements, but to do so in a way that makes sure we are also 
protecting taxpayer dollars and the Medicare trust fund.
  I do regret that we were unable to include administrative funding for 
the Centers for Medicare and Medicaid Services (CMS) to implement these 
new changes. Stakeholders are currently frustrated because the process 
does not move fast enough; adding new responsibilities on top of an 
already slow process--with no new funding--is going to burden the 
agency and make it more difficult to meet the stakeholders' desired 
time frame for resolution. I hope that at some future date we can 
provide a reasonable sum to speed this process along.
  I would like to clarify one additional point regarding the changes in 
this bill. The new process we have established for resolving disputes 
of claims posted on the web portal is not intended to supplant the 
ordinary appeals process for MSP activities. I believe that is clear in 
the language, but I want to note there should be no ambiguity.
  I am also pleased that a bill Congresswoman Matsui has been a clear 
leader on is included in this package today. She has worked tirelessly 
on this IVIG issue, and I am hopeful that this demonstration project 
she has championed will save both save money for the Medicare program 
and improve access to needed services for this vulnerable population. I 
thank her for her leadership on this issue.
  I thank Chairman Upton for working on these two issues with us, and 
our colleagues on the Ways and Means Committee who worked to bring 
these bills to the floor, and I look forward to next Congress where 
hopefully we will find additional areas of common ground to work on.
  Mr. REICHERT. Madam Speaker, I rise today to express my support for 
H.R. 1845. Title II addresses a set of issues involving the employers 
and the casualty insurance industry and the Medicare Secondary Payer 
(MSP) law.
  However, this is not the only set of MSP issues that impact workers' 
compensation that also needs to be addressed. My legislation, H.R. 
5284, the Medicare Secondary Payer and Workers' Compensation Settlement 
Agreement Act, is cosponsored by Representative Mike Thompson and has 
bipartisan support.
  This legislation aims to resolve the delays by the Centers for 
Medicare and Medicaid Services (CMS) in reviewing workers' compensation 
settlements to determine the appropriate set-aside amount to be 
maintained by Medicare beneficiaries to pay for future medical costs in 
which Medicare may have an interest.
  H.R. 5284 creates a system of certainty and allows the workers' 
compensation settlement process to move forward while eliminating 
millions of dollars in administrative costs. It will help create clear 
and consistent standards, currently lacking in the process, to address 
workers' compensation issues. Most importantly, it will benefit all 
parties involved--injured workers, employers, insurers and CMS.
  I am hopeful that the House of Representatives will be able to move 
H.R. 5284 towards enactment.
  Mr. VAN HOLLEN. Madam Speaker, I rise in support of H.R. 1845, a 
combination of two common-sense Medicare reforms that would improve 
access to intravenous immune globulin (IVIG) home infusion for 
beneficiaries with primary immunodeficiency diseases while streamlining 
the process for repayments to the Medicare Trust Fund.
  While the Medicare Modernization Act of 2003 sought to ensure that 
patients needing IVIG therapy could receive their infusions at home, 
the current policy does not cover the items and services necessary for 
providers to administer it in the home. As a result, access to home 
infusion is limited and seniors who rely solely on Medicare have no 
choice but to receive their treatments in the hospital, a more risky 
environment for immune deficient patients. The Medicare IVIG Access Act 
would create a three-year demonstration project that would study 
coverage of the items and services needed to administer IVIG home 
infusion.
  This legislation is fiscally responsible, paid for through the 
inclusion of the Strengthening Medicare and Repaying Taxpayers (SMART) 
Act. The SMART Act would sensibly reform the Medicare Secondary Payer 
system, increasing the likelihood of and speed up reimbursements to the 
Medicare Trust Fund. This is a win-win--beneficiaries and companies 
will be able to resolve their claims faster and the Trust Fund will be 
strengthened through a more efficient repayment process.
  I urge my colleagues to support this legislation.
  The SPEAKER pro tempore. 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. 1845, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. BRADY of Texas. Madam Speaker, on that I demand the yeas and 
nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this question will be postponed.

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