H. R. 1845 

One Hundred Twelfth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Tuesday, 

the third day of January, two thousand and twelve 

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. 

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’’. 

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). 
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(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 
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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 
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(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 
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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 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.— 
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‘‘(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— 
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‘‘(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 
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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. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.