I 117TH CONGRESS 1ST SESSION H. R. 3808 To provide for a demonstration project to further examine the benefits of providing coverage and payment for items and services necessary to administer intravenous immune globulin (IVIG) in the home, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 11, 2021 Mr. BLUMENAUER (for himself, Mr. SMITH of New Jersey, and Mr. BUTTERFIELD) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for a demonstration project to further examine the benefits of providing coverage and payment for items and services necessary to administer intravenous immune globulin (IVIG) in the home, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medicare IVIG Access 4 Enhancement Act’’. 5 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 2 •HR 3808 IH SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 1 PROJECT. 2 (a) ESTABLISHMENT.—The Secretary of Health and 3 Human Services (in this section referred to as the ‘‘Sec- 4 retary’’) shall establish and implement a demonstration 5 project under part B of title XVIII of the Social Security 6 Act to evaluate the benefits of providing payment for items 7 and services needed for the in-home administration of in- 8 travenous immune globulin for the treatment of chronic 9 inflammatory demyelinating polyneuropathy or multifocal 10 motor neuropathy. 11 (b) DURATION AND SCOPE.— 12 (1) DURATION.—Beginning not later than 1 13 year after the date of enactment of this Act, the 14 Secretary shall conduct the demonstration project 15 for a period of 5 years. 16 (2) SCOPE.—The Secretary shall, subject to 17 subsection (d), enroll not greater than 3,000 Medi- 18 care beneficiaries who have been diagnosed with 19 chronic inflammatory demyelinating polyneuropathy 20 or multifocal motor neuropathy for participation in 21 the demonstration project. Subject to subsection (d), 22 a Medicare beneficiary may participate in the dem- 23 onstration project on a voluntary basis and may ter- 24 minate participation at any time. 25 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 3 •HR 3808 IH (c) COVERAGE.—Except as otherwise provided in this 1 section, items and services for which payment may be 2 made under the demonstration program shall be treated 3 and covered under part B of title XVIII of the Social Se- 4 curity Act in the same manner as similar items and serv- 5 ices covered under such part. 6 (d) ELIGIBILITY.—In order to participate in the dem- 7 onstration project, a Medicare beneficiary must— 8 (1) be covered under the original Medicare fee- 9 for-service program under parts A and B of title 10 XVIII of the Social Security Act and not enrolled in 11 a Medicare Advantage plan under part C of such 12 Act; 13 (2) require intravenous immunoglobulin for the 14 treatment of chronic inflammatory demyelinating 15 polyneuropathy or multifocal motor neuropathy; and 16 (3) meet any other eligibility requirements spec- 17 ified by the Secretary. 18 (e) PAYMENT.— 19 (1) INTRAVENOUS IMMUNE GLOBULIN.—For in- 20 travenous immune globulin furnished under this sec- 21 tion, the Secretary shall make payment using the 22 payment methodology under section 1847A of the 23 Social Security Act (42 U.S.C. 1395w–3a). 24 (2) OTHER ITEMS AND SERVICES.— 25 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 4 •HR 3808 IH (A) IN GENERAL.—The Secretary shall es- 1 tablish, subject to subparagraph (B), a per-visit 2 payment amount for items and services (other 3 than intravenous immune globulin) needed for 4 the in-home infusion of intravenous immune 5 globulin for the treatment of chronic inflam- 6 matory demyelinating polyneuropathy or 7 multifocal motor neuropathy based on the na- 8 tional per visit low-utilization payment amount 9 under the prospective payment system for home 10 health services established under section 1895 11 of the Social Security Act (42 U.S.C. 1395fff). 12 (B) LIMITATION.—In establishing the per 13 visit payment amount established under sub- 14 paragraph (A) for items and services described 15 in such subparagraph, the Secretary shall con- 16 sider— 17 (i) including a component for requisite 18 nursing care; 19 (ii) establishing an appropriate fur- 20 nishing fee for intravenous immune glob- 21 ulin similar to the separate payment for 22 clotting factors under section 1842(o)(5) of 23 the Social Security Act (42 U.S.C. 24 1395u(o)(5)); 25 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 5 •HR 3808 IH (iii) otherwise acknowledging the 1 length of infusions for individuals needing 2 in-home infusion of intravenous globulin 3 for treatment described in subparagraph 4 (A); 5 (iv) that, in total, such amount poten- 6 tially not being less than at least 2.5 times 7 the payment amount applied under the 8 demonstration project established under 9 section 101 of the Medicare IVIG Access 10 and Strengthening Medicare and Repaying 11 Taxpayers Act of 2012 (Public Law 112– 12 242) for items and services needed for the 13 in-home administration of intravenous im- 14 mune globulin for the treatment of pri- 15 mary immune deficiency diseases in rec- 16 ognition of the fact that patients with 17 chronic inflammatory demyelinating poly- 18 neuropathy or multifocal motor neuropathy 19 tend to have longer infusion times, require 20 more product, and have additional health- 21 care needs related to underlying neuromus- 22 cular challenges; and 23 (v) developing such amount in con- 24 sultation with stakeholders. 25 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 6 •HR 3808 IH (f) WAIVER AUTHORITY.—The Secretary may waive 1 such requirements of title XVIII of the Social Security Act 2 as may be necessary to carry out the demonstration 3 project. 4 (g) FINAL EVALUATION AND REPORT.—Not later 5 than one year after the third year of the demonstration 6 project, the Secretary shall submit to Congress a report 7 that contains— 8 (1) a current and projected evaluation of the 9 impact of the demonstration project on access for 10 Medicare beneficiaries with chronic inflammatory 11 demyelinating polyneuropathy and Medicare bene- 12 ficiaries with multifocal motor neuropathy to items 13 and services needed for the in-home administration 14 of intravenous immune globin that also draws upon 15 information and data from the ongoing home infu- 16 sion demonstration project for primary immuno- 17 deficiency diseases (Public Law 112–242) and the 18 recent effort to provide an adequate coverage benefit 19 for therapies infused through durable medical equip- 20 ment (HCPCS CMS–1738–P); and 21 (2) a final analysis of the appropriateness of ex- 22 panding or extending the demonstration project, or 23 implementing a new methodology for payment for in- 24 travenous immune globulins in all care settings 25 VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS 7 •HR 3808 IH under part B of title XVIII of the Social Security 1 Act (42 U.S.C. 1395k et seq.), or augmenting exist- 2 ing benefits to provide proper access for home infu- 3 sion of intravenous immune globulins, and, to the 4 extent such analysis determines such an expansion, 5 extension, or methodology appropriate, recommenda- 6 tions for such expansion, extension, or methodology, 7 respectively, along with an explanation of how CMS 8 intends to implement or otherwise provide such a 9 permanent benefit or mechanism for access during 10 the fifth year of the demo to ensure nondisruptions 11 in care for impacted patients. 12 (h) DEFINITIONS.—In this section: 13 (1) DEMONSTRATION PROJECT.—The term 14 ‘‘demonstration project’’ means the demonstration 15 project conducted under this Act. 16 (2) MEDICARE BENEFICIARY.—The term 17 ‘‘Medicare beneficiary’’ means an individual who is 18 enrolled for benefits under part B of title XVIII of 19 the Social Security Act. 20 Æ VerDate Sep 11 2014 23:48 Jul 13, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H3808.IH H3808 ctelli on DSK11ZRN23PROD with BILLS