[112th Congress Public Law 242]
[From the U.S. Government Printing Office]



[[Page 2373]]

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

[[Page 126 STAT. 2374]]

Public Law 112-242
112th Congress

                                 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. <<NOTE: Jan. 10, 
                         2013 -  [H.R. 1845]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Medicare IVIG 
Access and Strengthening Medicare and Repaying Taxpayers Act of 2012. 42 
USC 1305 note.>> 
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. <<NOTE: 42 USC 1395l note.>>  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) <<NOTE: Effective date. Time period.>>  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).

[[Page 126 STAT. 2375]]

    (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

[[Page 126 STAT. 2376]]

                                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 <<NOTE: Deadline.>> 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

[[Page 126 STAT. 2377]]

                                (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 <<NOTE: Proposal.>> such process 
                                the individual (or representative) must 
                                provide documentation explaining the 
                                discrepancy and a proposal to resolve 
                                such discrepancy. Within 11 <<NOTE: Time 
                                period.>> 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) <<NOTE: Definition.>>  
                                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

[[Page 126 STAT. 2378]]

                                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) <<NOTE: Regulations. Deadline.>>  
                                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 <<NOTE: Definition.>> 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 <<NOTE: Regulations.>> 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 <<NOTE: Notification.>> 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.--

[[Page 126 STAT. 2379]]

                          ``(i) <<NOTE: Deadlines. Publication.>>  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 <<NOTE: Review.>> 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--

[[Page 126 STAT. 2380]]

                          ``(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 <<NOTE: 42 USC 1395y note.>> 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 <<NOTE: Deadline. Notice. Federal Register, 
                publications. Time period.>> 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 <<NOTE: Deadline. Time 
                period. Notification.>> 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

[[Page 126 STAT. 2381]]

                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 <<NOTE: Deadline. Notification.>> 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 <<NOTE: Applicability. 42 USC 1395y 
note.>> 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.

    Approved January 10, 2013.

LEGISLATIVE HISTORY--H.R. 1845:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 158 (2012):
            Dec. 19, considered and passed House.
            Dec. 21, considered and passed Senate.

                                  <all>