II 

112TH CONGRESS 

2D SESSION H. R. 1845 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 20, 2012 

Received 

AN ACT 

To provide a demonstration project providing Medicare coverage for in-home administration of intravenous immune 

globulin (IVIG) and to amend title XVIII of the Social 

Security Act with respect to the application of Medicare 

secondary payer rules for certain claims. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medicare IVIG Access 

3 and Strengthening Medicare and Repaying Taxpayers Act 

4 of 2012’’. 

5 TITLE I—MEDICARE IVIG 

6 ACCESS 

7 SEC. 101. MEDICARE PATIENT IVIG ACCESS DEMONSTRA8 TION PROJECT. 

9 (a) ESTABLISHMENT.—The Secretary shall establish 

10 and implement a demonstration project under part B of 

11 title XVIII of the Social Security Act to evaluate the bene12 fits of providing payment for items and services needed 

13 for the in-home administration of intravenous immune 

14 globin for the treatment of primary immune deficiency dis15 eases. 

16 (b) DURATION AND SCOPE.— 

17 (1) DURATION.—Beginning not later than one 

18 year after the date of enactment of this Act, the 

19 Secretary shall conduct the demonstration project 

20 for a period of 3 years. 

21 (2) SCOPE.—The Secretary shall enroll not 

22 more than 4,000 Medicare beneficiaries who have 

23 been diagnosed with primary immunodeficiency dis24 ease for participation in the demonstration project. 

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1 onstration project on a voluntary basis and may ter2 minate participation at any time. 

3 (c) COVERAGE.—Except as otherwise provided in this 

4 section, items and services for which payment may be 

5 made under the demonstration program shall be treated 

6 and covered under part B of title XVIII of the Social Se7 curity Act in the same manner as similar items and serv8 ices covered under such part. 

9 (d) PAYMENT.—The Secretary shall establish a per 

10 visit payment amount for items and services needed for 

11 the in-home administration of intravenous immune globin 

12 based on the national per visit low-utilization payment 

13 amount under the prospective payment system for home 

14 health services established under section 1895 of the So15 cial Security Act (42 U.S.C. 1395fff). 

16 (e) WAIVER AUTHORITY.—The Secretary may waive 

17 such requirements of title XVIII of the Social Security Act 

18 as may be necessary to carry out the demonstration 

19 project. 

20 (f) STUDY AND REPORT TO CONGRESS.— 

21 (1) INTERIM EVALUATION AND REPORT.—Not 

22 later than three years after the date of enactment of 

23 this Act, the Secretary shall submit to Congress a 

24 report that contains an interim evaluation of the im25 pact of the demonstration project on access for 


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1 Medicare beneficiaries to items and services needed 

2 for the in-home administration of intravenous im3 mune globin. 

4 (2) FINAL EVALUATION AND REPORT.—Not 

5 later than one year after the date of completion of 

6 the demonstration project, the Secretary shall sub7 mit to Congress a report that contains the following: 

8 (A) A final evaluation of the impact of the 

9 demonstration project on access for Medicare 

10 beneficiaries to items and services needed for 

11 the in-home administration of intravenous im12 mune globin. 

13 (B) An analysis of the appropriateness of 

14 implementing a new methodology for payment 

15 for intravenous immune globulins in all care 

16 settings under part B of title XVIII of the So17 cial Security Act (42 U.S.C. 1395k et seq.). 

18 (C) An update to the report entitled 

19 ‘‘Analysis of Supply, Distribution, Demand, and 

20 Access Issues Associated with Immune Globulin 

21 Intravenous (IGIV)’’, issued in February 2007 

22 by the Office of the Assistant Secretary for 

23 Planning and Evaluation of the Department of 

24 Health and Human Services. 


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1 (g) FUNDING.—There shall be made available to the 

2 Secretary to carry out the demonstration project not more 

3 than $45,000,000 from the Federal Supplementary Med4 ical Insurance Trust Fund under section 1841 of the So5 cial Security Act (42 U.S.C. 1395t). 

6 (h) DEFINITIONS.—In this section: 

7 (1) DEMONSTRATION PROJECT.—The term 

8 ‘‘demonstration project’’ means the demonstration 

9 project conducted under this section. 

10 (2) MEDICARE BENEFICIARY.—The term 

11 ‘‘Medicare beneficiary’’ means an individual who is 

12 enrolled for benefits under part B of title XVIII of 

13 the Social Security Act. 

14 (3) SECRETARY.—The term ‘‘Secretary’’ means 

15 the Secretary of Health and Human Services. 

16 TITLE II—STRENGTHENING 

17 MEDICARE SECONDARY 

18 PAYER RULES 

19 SEC. 201. DETERMINATION OF REIMBURSEMENT AMOUNT 

20 THROUGH CMS WEBSITE TO IMPROVE PRO21 GRAM EFFICIENCY. 

22 Section 1862(b)(2)(B) of the Social Security Act (42 

23 U.S.C. 1395y(b)(2)(B)) is amended by adding at the end 

24 the following new clause: 


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1 ‘‘(vii) USE OF WEBSITE TO DETER2 MINE FINAL CONDITIONAL REIMBURSE3 MENT AMOUNT.— 

4 ‘‘(I) NOTICE TO SECRETARY OF

5 EXPECTED DATE OF A SETTLEMENT, 

6 JUDGMENT, ETC.—In the case of a 

7 payment made by the Secretary pur8 suant to clause (i) for items and serv9 ices provided to the claimant, the 

10 claimant or applicable plan (as de11 fined in paragraph (8)(F)) may at 

12 any time beginning 120 days before 

13 the reasonably expected date of a set14 tlement, judgment, award, or other 

15 payment, notify the Secretary that a 

16 payment is reasonably expected and 

17 the expected date of such payment. 

18 ‘‘(II) SECRETARIAL PROVIDING

19 ACCESS TO CLAIMS INFORMATION

20 THROUGH A WEBSITE.—The Sec21 retary shall maintain and make avail22 able to individuals to whom items and 

23 services are furnished under this title 

24 (and to authorized family or other 

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1 lations and to an applicable plan 

2 which has obtained the consent of the 

3 individual) access to information on 

4 the claims for such items and services 

5 (including payment amounts for such 

6 claims), including those claims that 

7 relate to a potential settlement, judg8 ment, award, or other payment . Such 

9 access shall be provided to an indi10 vidual, representative, or plan through 

11 a website that requires a password to 

12 gain access to the information. The 

13 Secretary shall update the information 

14 on claims and payments on such 

15 website in as timely a manner as pos16 sible but not later than 15 days after 

17 the date that payment is made. Infor18 mation related to claims and pay19 ments subject to the notice under sub20 clause (I) shall be maintained and 

21 made available consistent with the fol22 lowing: 

23 ‘‘(aa) The information shall 

24 be as complete as possible and 

25 shall include provider or supplier 


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1 name, diagnosis codes (if any), 

2 dates of service, and conditional 

3 payment amounts. 

4 ‘‘(bb) The information accu5 rately identifies those claims and 

6 payments that are related to a 

7 potential settlement, judgment, 

8 award, or other payment to 

9 which the provisions of this sub10 section apply. 

11 ‘‘(cc) The website provides a 

12 method for the receipt of secure 

13 electronic communications with 

14 the individual, representative, or 

15 plan involved. 

16 ‘‘(dd) The website provides 

17 that information is transmitted 

18 from the website in a form that 

19 includes an official time and date 

20 that the information is trans21 mitted. 

22 ‘‘(ee) The website shall per23 mit the individual, representative, 

24 or plan to download a statement 

25 of reimbursement amounts (in 


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1 this clause referred to as a ‘state2 ment of reimbursement amount’) 

3 on payments for claims under 

4 this title relating to a potential 

5 settlement, judgment, award, or 

6 other payment. 

7 ‘‘(III) USE OF TIMELY WEB

8 DOWNLOAD AS BASIS FOR FINAL CON9 DITIONAL AMOUNT.—If an individual 

10 (or other claimant or applicable plan 

11 with the consent of the individual) ob12 tains a statement of reimbursement 

13 amount from the website during the 

14 protected period as defined in sub15 clause (V) and the related settlement, 

16 judgment, award or other payment is 

17 made during such period, then the 

18 last statement of reimbursement 

19 amount that is downloaded during 

20 such period and within 3 business 

21 days before the date of the settlement, 

22 judgment, award, or other payment 

23 shall constitute the final conditional 

24 amount subject to recovery under 


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1 clause (ii) related to such settlement, 

2 judgment, award, or other payment. 

3 ‘‘(IV) RESOLUTION OF DISCREP4 ANCIES.—If the individual (or author5 ized representative) believes there is a 

6 discrepancy with the statement of re7 imbursement amount, the Secretary 

8 shall provide a timely process to re9 solve the discrepancy. Under such 

10 process the individual (or representa11 tive) must provide documentation ex12 plaining the discrepancy and a pro13 posal to resolve such discrepancy. 

14 Within 11 business days after the 

15 date of receipt of such documentation, 

16 the Secretary shall determine whether 

17 there is a reasonable basis to include 

18 or remove claims on the statement of 

19 reimbursement. If the Secretary does 

20 not make such determination within 

21 the 11 business-day period, then the 

22 proposal to resolve the discrepancy 

23 shall be accepted. If the Secretary de24 termines within such period that there 

25 is not a reasonable basis to include or 


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1 remove claims on the statement of re2 imbursement, the proposal shall be re3 jected. If the Secretary determines 

4 within such period that there is a rea5 sonable basis to conclude there is a 

6 discrepancy, the Secretary must re7 spond in a timely manner by agreeing 

8 to the proposal to resolve the discrep9 ancy or by providing documentation 

10 showing with good cause why the Sec11 retary is not agreeing to such pro12 posal and establishing an alternate 

13 discrepancy resolution. In no case 

14 shall the process under this subclause 

15 be treated as an appeals process or as 

16 establishing a right of appeal for a 

17 statement of reimbursement amount 

18 and there shall be no administrative 

19 or judicial review of the Secretary’s 

20 determinations under this subclause. 

21 ‘‘(V) PROTECTED PERIOD.—In 

22 subclause (III), the term ‘protected 

23 period’ means, with respect to a set24 tlement, judgment, award or other 

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1 dent, the portion (if any) of the period 

2 beginning on the date of notice under 

3 subclause (I) with respect to such set4 tlement, judgment, award, or other 

5 payment that is after the end of a 

6 Secretarial response period beginning 

7 on the date of such notice to the Sec8 retary. Such Secretarial response pe9 riod shall be a period of 65 days, ex10 cept that such period may be extended 

11 by the Secretary for a period of an 

12 additional 30 days if the Secretary de13 termines that additional time is re14 quired to address claims for which 

15 payment has been made. Such Secre16 tarial response period shall be ex17 tended and shall not include any days 

18 for any part of which the Secretary 

19 determines (in accordance with regu20 lations) that there was a failure in the 

21 claims and payment posting system 

22 and the failure was justified due to 

23 exceptional circumstances (as defined 

24 in such regulations). Such regulations 

25 shall define exceptional circumstances 


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1 in a manner so that not more than 1 

2 percent of the repayment obligations 

3 under this subclause would qualify as 

4 exceptional circumstances. 

5 ‘‘(VI) EFFECTIVE DATE.—The 

6 Secretary shall promulgate final regu7 lations to carry out this clause not 

8 later than 9 months after the date of 

9 the enactment of this clause. 

10 ‘‘(VII) WEBSITE INCLUDING SUC11 CESSOR TECHNOLOGY.—In this 

12 clause, the term ‘website’ includes any 

13 successor technology. 

14 ‘‘(viii) RIGHT OF APPEAL FOR SEC15 ONDARY PAYER DETERMINATIONS RELAT16 ING TO LIABILITY INSURANCE (INCLUDING

17 SELF-INSURANCE), NO FAULT INSURANCE, 

18 AND WORKERS’ COMPENSATION LAWS AND

19 PLANS.—The Secretary shall promulgate 

20 regulations establishing a right of appeal 

21 and appeals process, with respect to any 

22 determination under this subsection for a 

23 payment made under this title for an item 

24 or service for which the Secretary is seek25 ing to recover conditional payments from 


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1 an applicable plan (as defined in para2 graph (8)(F)) that is a primary plan under 

3 subsection (A)(ii), under which the applica4 ble plan involved, or an attorney, agent, or 

5 third party administrator on behalf of such 

6 plan, may appeal such determination. The 

7 individual furnished such an item or serv8 ice shall be notified of the plan’s intent to 

9 appeal such determination’’. 

10 SEC. 202. FISCAL EFFICIENCY AND REVENUE NEUTRALITY. 

11 (a) IN GENERAL.—Section 1862(b) of the Social Se12 curity Act (42 U.S.C. 1395y(b)) is amended— 

13 (1) in paragraph (2)(B)(ii), by striking ‘‘A pri14 mary plan’’ and inserting ‘‘Subject to paragraph (9), 

15 a primary plan’’; and 

16 (2) by adding at the end the following new 

17 paragraph: 

18 ‘‘(9) EXCEPTION.— 

19 ‘‘(A) IN GENERAL.—Clause (ii) of para20 graph (2)(B) and any reporting required by 

21 paragraph (8) shall not apply with respect to 

22 any settlement, judgment, award, or other pay23 ment by an applicable plan arising from liability 

24 insurance (including self-insurance) and from 

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1 ing alleged ingestion, implantation, or exposure 

2 cases) constituting a total payment obligation 

3 to a claimant of not more than the single 

4 threshold amount calculated by the Secretary 

5 under subparagraph (B) for the year involved. 

6 ‘‘(B) ANNUAL COMPUTATION OF THRESH7 OLD.— 

8 ‘‘(i) IN GENERAL.—Not later than 

9 November 15 before each year, the Sec10 retary shall calculate and publish a single 

11 threshold amount for settlements, judg12 ments, awards, or other payments for obli13 gations arising from liability insurance (in14 cluding self-insurance) and for alleged 

15 physical trauma-based incidents (excluding 

16 alleged ingestion, implantation, or exposure 

17 cases) subject to this section for that year. 

18 The annual single threshold amount for a 

19 year shall be set such that the estimated 

20 average amount to be credited to the Medi21 care trust funds of collections of condi22 tional payments from such settlements, 

23 judgments, awards, or other payments 

24 arising from liability insurance (including 

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1 dents subject to this section shall equal the 

2 estimated cost of collection incurred by the 

3 United States (including payments made 

4 to contractors) for a conditional payment 

5 arising from liability insurance (including 

6 self-insurance) and for such alleged inci7 dents subject to this section for the year. 

8 At the time of calculating, but before pub9 lishing, the single threshold amount for a 

10 year, the Secretary shall inform, and seek 

11 review of, the Comptroller General of the 

12 United States with regard to such amount. 

13 ‘‘(ii) PUBLICATION.—The Secretary 

14 shall include, as part of such publication 

15 for a year— 

16 ‘‘(I) the estimated cost of collec17 tion incurred by the United States 

18 (including payments made to contrac19 tors) for a conditional payment aris20 ing from liability insurance (including 

21 self-insurance) and for such alleged 

22 incidents; and 

23 ‘‘(II) a summary of the method24 ology and data used by the Secretary 


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1 in computing such threshold amount 

2 and such cost of collection. 

3 ‘‘(C) EXCLUSION OF ONGOING EX4 PENSES.—For purposes of this paragraph and 

5 with respect to a settlement, judgment, award, 

6 or other payment not otherwise addressed in 

7 clause (ii) of paragraph (2)(B) that includes on8 going responsibility for medical payments (ex9 cluding settlements, judgments, awards, or 

10 other payments made by a workers’ compensa11 tion law or plan or no fault insurance), the 

12 amount utilized for calculation of the threshold 

13 described in subparagraph (A) shall include 

14 only the cumulative value of the medical pay15 ments made under this title. 

16 ‘‘(D) REPORT TO CONGRESS.—Not later 

17 than November 15 before each year, the Sec18 retary shall submit to the Congress a report on 

19 the single threshold amount for settlements, 

20 judgments, awards, or other payments for con21 ditional payment obligations arising from liabil22 ity insurance (including self-insurance) and al23 leged incidents described in subparagraph (A) 

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1 ments for conditional payment obligations aris2 ing from worker compensation cases and from 

3 no fault insurance cases subject to this section 

4 for the year. For each such report, the Sec5 retary shall— 

6 ‘‘(i) calculate the threshold amount by 

7 using the methodology applicable to certain 

8 liability claims described in subparagraph 

9 (B); and 

10 ‘‘(ii) include a summary of the meth11 odology and data used in calculating each 

12 threshold amount and the amount of esti13 mated savings under this title achieved by 

14 the Secretary implementing each such 

15 threshold.’’. 

16 (b) EFFECTIVE DATE.—The amendments made by 

17 subsection (a) shall apply to years beginning with 2014. 

18 SEC. 203. REPORTING REQUIREMENT. 

19 Section 1862(b)(8) of the Social Security Act (42 

20 U.S.C. 1395y(b)(8)) is amended— 

21 (1) in the first sentence of subparagraph (E)(i), 

22 by striking ‘‘shall be subject’’ and all that follows 

23 through the end of the sentence and inserting the 

24 following: ‘‘may be subject to a civil money penalty 


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1 of up to $1,000 for each day of noncompliance with 

2 respect to each claimant.’’; and 

3 (2) by adding at the end the following new sub4 paragraph: 

5 ‘‘(I) REGULATIONS.—Not later than 60 

6 days after the date of the enactment of this 

7 subparagraph, the Secretary shall publish a no8 tice in the Federal Register soliciting proposals, 

9 which will be accepted during a 60-day period, 

10 for the specification of practices for which sanc11 tions will and will not be imposed under sub12 paragraph (E), including not imposing sanc13 tions for good faith efforts to identify a bene14 ficiary pursuant to this paragraph under an ap15 plicable entity responsible for reporting infor16 mation. After considering the proposals so sub17 mitted, the Secretary, in consultation with the 

18 Attorney General, shall publish in the Federal 

19 Register, including a 60-day period for com20 ment, proposed specified practices for which 

21 such sanctions will and will not be imposed. 

22 After considering any public comments received 

23 during such period, the Secretary shall issue 

24 final rules specifying such practices.’’. 


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1 SEC. 204. USE OF SOCIAL SECURITY NUMBERS AND OTHER 

2 IDENTIFYING INFORMATION IN REPORTING. 

3 Section 1862(b)(8)(B) of the Social Security Act (42 

4 U.S.C. 1395y(b)(8)(B)) is amended by adding at the end 

5 (after and below clause (ii)) the following: 

6 ‘‘Not later than 18 months after the date of en7 actment of this sentence, the Secretary shall 

8 modify the reporting requirements under this 

9 paragraph so that an applicable plan in com10 plying with such requirements is permitted but 

11 not required to access or report to the Sec12 retary beneficiary social security account num13 bers or health identification claim numbers, ex14 cept that the deadline for such modification 

15 shall be extended by one or more periods (speci16 fied by the Secretary) of up to 1 year each if 

17 the Secretary notifies the committees of juris18 diction of the House of Representatives and of 

19 the Senate that the prior deadline for such 

20 modification, without such extension, threatens 

21 patient privacy or the integrity of the secondary 

22 payer program under this subsection. Any such 

23 deadline extension notice shall include informa24 tion on the progress being made in imple25 menting such modification and the anticipated 

26 implementation date for such modification.’’. 


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1 SEC. 205. STATUTE OF LIMITATIONS. 

2 (a) IN GENERAL.—Section 1862(b)(2)(B)(iii) of the 

3 Social Security Act (42 U.S.C. 1395y(b)(2)(B)(iii)) is 

4 amended by adding at the end the following new sentence: 

5 ‘‘An action may not be brought by the United States 

6 under this clause with respect to payment owed unless the 

7 complaint is filed not later than 3 years after the date 

8 of the receipt of notice of a settlement, judgment, award, 

9 or other payment made pursuant to paragraph (8) relating 

10 to such payment owed.’’. 

11 (b) EFFECTIVE DATE.—The amendment made by 

12 subsection (a) shall apply with respect to actions brought 

13 and penalties sought on or after 6 months after the date 

14 of the enactment of this Act. 

Passed the House of Representatives December 19, 

2012. 

Attest: KAREN L. HAAS, 

Clerk. 


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