Title II, SEC. 2006. COVERAGE OF HOME INFUSION DRUG THERAPY SERVICES. (a) In General. Section 1832(a)(2)(A) of the Social Security Act (42 U.S.C. 1395k(a)(2)(A)) is amended by inserting ``and home infusion drug therapy services'' before the semicolon. (b) Home Infusion Drug Therapy Services Defined. Section 1861 of such Act (42 U.S.C. 1395x) is amended (1) by redesignating the subsection (jj) inserted by section 4156(a)(2) of the Omnibus Budget Reconciliation Act of 1990 as subsection (kk); and (2) by inserting after such subsection the following new subsection: ``Home Infusion Drug Therapy Services ``(ll)(1) The term `home infusion drug therapy services' means the items and services described in paragraph (2) furnished to an individual who is under the care of a physician ``(A) in a place of residence used as the individual's home, ``(B) by a qualified home infusion drug therapy provider (as defined in paragraph (3)) or by others under arrangements with them made by that provider, and ``(C) under a plan established and periodically reviewed by a physician. ``(2) The items and services described in this paragraph are such nursing, pharmacy, and related services (including medical supplies, intravenous fluids, delivery, and equipment) as are necessary to conduct safely and effectively a drug regimen through use of a covered home infusion drug (as defined in subsection (t)(5)), but do not include such covered outpatient drugs. ``(3) The term `qualified home infusion drug therapy provider' means any entity that the secretary determines meets the following requirements: ``(A) The entity is capable of providing or arranging for the items and services described in paragraph (2) and covered home infusion drugs. ``(B) The entity maintains clinical records on all patients. ``(C) The entity adheres to written protocols and policies with respect to the provision of items and services. ``(D) The entity makes services available (as needed) seven days a week on a 24-hour basis. ``(E) The entity coordinates all service with the patient's physician. ``(F) The entity conducts a quality assessment and assurance program, including drug regimen review and coordination of patient care. ``(G) The entity assures that only trained personnel provide covered home infusion drugs (and any other service for which training is required to provide the service safely). ``(H) The entity assumes responsibility for the quality of services provided by others under arrangements with the entity. ``(I) In the case of an entity in any State in which State or applicable local law provides for the licensing of entities of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing entities of this nature, as meeting the standards established for such licensing. ``(J) The entity meets such other requirements as the Secretary may determine are necessary to assure the safe and effective provision of home infusion drug therapy services and the efficient administration of the home infusion drug therapy benefit.''. (c) Payment. (1) In general. Section 1833 of such Act (42 U.S.C. 1395l) is amended (A) in subsection (a)(2)(B), by striking ``or (E)'' and inserting ``(E), or (F)'', (B) in subsection (a)(2)(D), by striking ``and'' at the end, (C) in subsection (a)(2)(E), by striking the semicolon and inserting ``; and'', (D) by inserting after subsection (a)(2)(E) the following new subparagraph: ``(F) with resect to home infusion drug therapy services, the amounts described in section 1834(j);'', (E) in the first sentence of subsection (b), by striking ``services, (3)'' and inserting ``services and home infusion drug therapy services, (3)''. (2) Amount described. Section 1834 of such Act, as amended by section 13544(b)(i) of OBRA 1993, is amended by adding at the end the following new subsection: ``(j) Home infusion Drug Therapy Services. ``(1) In general. With respect to home infusion drug therapy services, payment under this part shall be made in an amount equal to the lesser of the actual charges for such services or the fee schedule established under paragraph (2). ``(2) Establishment of fee schedule. The Secretary shall establish by regulation before the beginning of 1996 and each succeeding year a fee schedule for home infusion drug therapy services for which payment is made under this part. A fee schedule established under this subsection shall be on a per diem basis.''. (3) Prohibition on certain referrals. Section 1877(h)(6) of such Act (42 U.S.C. 1395nn(h)(6)), as amended by section 13562(a) of OBRA 1993, is amended by adding at the end the following: ``(L) Home infusion drug therapy services.''. (d) Certification. Section 1835(a)(2) of such Act (42 U.S.C. 1395n(a)(2)) is amended (1) by striking ``and'' at the end of subparagraph (E), (2) by striking the period at the end of subparagraph (F) and inserting ``; and'', and (3) by inserting after subparagraph (F) the following: ``(G) in the case of home infusion drug therapy services, (i) such services are or were required because the individual needed such services for the administration of a covered home infusion drug, (ii) a plan for furnishing such services has been established and is reviewed periodically by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician.''. (e) Certification of Home infusion Drug Therapy Providers; Intermediate Sanctions for Noncompliance. (1) Treatment as provider of services. Section 1861(u) of such Act (42 U.S.C. 1395x(u)) is amended by inserting ``home infusion drug therapy provider,'' after ``hospice program,''. (2) Consultation with state agencies and other organizations. Section 1863 of such Act (42 U.S.C. 1395z) is amended by striking ``and (dd)(2)'' and inserting ``(dd)(2), and (ll)(3)''. (3) Use of state agencies in determining compliance. Section 1864(a) of such Act (42 U.S.C. 1395aa(a)) is amended (A) in the first sentence, by striking ``an agency is a hospice program'' and inserting ``an agency or entity is a hospice program or a home infusion drug therapy provider,'' after ``home health agency, or whether''; and (B) in the second sentence (i) by striking ``institution or agency'' and inserting ``institution, agency, or entity'', and (ii) by striking ``or hospice program'' and inserting ``hospice program, or home infusion drug therapy provider''. (4) Application of intermediate sanctions. Section 1846 of such Act (42 U.S.C. 1395w 2) is amended (A) in the heading, by adding ``and for qualified home infusion drug therapy providers'' at the end, (B) in subsection (a), by inserting ``or that a qualified home infusion drug therapy provider that is certified for participation under this title no longer substantially meets the requirements of section 1861(ll)(3)'' after ``under this part'', and (C) in subsection (b)(2)(A)(iv), by inserting ``or home infusion drug therapy services'' after ``clinical diagnostic laboratory tests''. (f) Use of Regional Intermediaries in Administration of Benefit. Section 1816 of such Act (42 U.S.C. 1395h) is amended by adding at the end the following new subsection: ``(k) With respect to carrying out functions relating to payment for home infusion drug therapy services and covered home infusion drugs, the Secretary may enter into contracts with agencies or organizations under this section to perform such functions on a regional basis.''.