COVERAGE OF HOME INTRAVENOUS DRUG THERAPY SERVICES.

SEC. 203. COVERAGE OF HOME INTRAVENOUS DRUG THERAPY SERVICES. (a) In General.—Section 1832(a)(2)(A) (42 U.S.C. 1395k(a)(2)(A)) is amended by inserting “and home intravenous drug therapy services” before the semicolon. (b) Home Intravenous Drug Therapy Services Defined.—Section 1861 (42 U.S.C. 1395x) is amended by adding at the end the following new subsection: “(jj) (1) The term ‘home intravenous 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 such individual’s home; “(B) by a qualified home intravenous drug therapy provider (as defined in paragraph (3)) or by others under arrangements with them made by such 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 an intravenously administered drug regimen through use of a covered home IV drug (as defined in subsection (t)(4)), but do not include such covered outpatient drugs. “(3) The term ‘qualified home intravenous drug therapy provider’ means any entity that the Secretary determines meets the following requirements: “(i) The entity is capable of providing or arranging for the items and services described in paragraph (2) and covered home IV drugs. “(ii) The entity maintains clinical records on all patients. “(iii) The entity adheres to written protocols and policies with respect to the provision of items and services. “(iv) The entity makes services available (as needed) seven days a week on a 24-hour basis. “(v) The entity coordinates all services with the patient’s physician. 102 STAT. 722 “(vi) The entity conducts a quality assessment and assurance program, including drug regimen review and coordination of patient care. “(vii) The entity assures that only trained personnel provide covered home IV drugs (and any other service for which training is required to safely provide the service). “(viii) The entity assumes responsibility for the quality of services provided by others under arrangements with the agency or entity. “(ix) 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, (I) is licensed pursuant to such law, or (II) 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. “(x) The entity meets such other requirements as the Secretary may determine are necessary to assure the safe and effective provision of home intravenous drug therapy services and the efficient administration of the home intravenous drug therapy benefit.”. (c) Payment.— (1) In general.— Part B is amended— (A) in subsection (a)(2)(B) of section 1833 (42 U.S.C. 13951), by striking “or (E)” and inserting “(E), or (F)”; (B) in subsection (a)(2)(D) of such section, by striking “and” at the end; (C) in subsection (a)(2)(E) of such section, by striking the semicolon and inserting “; and”; (D) by inserting after subsection (a)(2)(E) of such section the following new subparagraph: “(F) with respect to home intravenous drug therapy services, the amounts described in section 1834(d)(1);”; (E) in subsection (b) of such section, by striking “services, (3)” and inserting “services and home intravenous drug therapy services, (3)”; and (F) by adding at the end of section 1834, as amended by section 202(b)(4) of this Act, the following new subsection: “(d) Home Intravenous Drug Therapy Services.— “(1) In general.—With respect to home intravenous drug therapy services, subject to paragraph (3), 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 calendar year 1990 and each succeeding calendar year a fee schedule for home intravenous 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) Limitation on acceptance of, and payments for, certain referrals.— “(A) In general.— Except as provided in subparagraph (B), a home intravenous drug therapy provider may not provide home intravenous drug therapy services under this part to an individual if the individual’s referring physician (as defined in subparagraph (D)), or an immediate family member of the physician— 102 STAT. 723 “(i) has an ownership interest in the provider, or “(ii) receives compensation from the provider. “(B) Exceptions.— “(i) Subparagraph (A)(i) shall not apply— “(I) if the ownership interest is the ownership of stock which is traded over a publicly-regulated exchange and was purchased on terms generally available to the public, or “(II) if the provider is a sole home intravenous drug therapy provider (as defined by the Secretary) in a rural area. “(ii) Subparagraph (A)(ii) shall not apply if the compensation is reasonably related to items or services actually provided by the physician and does not vary in proportion to the number of referrals made by the referring physician, but such exception shall not apply to compensation provided for direct patient care services. “(iii) Subparagraph (A) shall not be construed to apply to a referring physician whose only ownership or financial relationship with the provider is as an uncompensated officer or director of the provider. “(iv) Subparagraph (A) also shall not apply in such cases, established by the Secretary in regulations, in which the nature of the ownership or compensation does not pose a substantial risk of program abuse. “(C) Sanctions.— “(i) Denial of payment.—No payment may be made under this part for home intravenous drug therapy services which are provided in violation of subparagraph (A). “(ii) Civil money penalty for improper claims.—Any person (including a home intravenous drug therapy provider or physician) that presents or causes to be presented a claim for an item or service that such person knows or should know is for an item or service for which payment may not be made under subparagraph (A) shall be subject to a civil money penalty of not more than $15,000 for each such item or service. The provisions of section 1128A (other than the first sentence of subsection (a) and other than subsection (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). “(D) Referring physician defined.—In this paragraph, the term ‘referring physician’ means, with respect to providing home intravenous drug therapy services to an individual, a physician who— “(i) prescribed the covered home IV drug for which the services are to be provided, or “(ii) established the plan of care for such services.”. (2) Propac study.— The Prospective Payment Assessment Commission shall conduct a study, and make recommendations 3 Congress and the Secretary of Health and Human Services by not later than March 1, 1991, concerning appropriate adjustlent to the payment amounts provided under section 1886(d) of be Social Security Act for inpatient hospital services to account 102 STAT. 724for reduced costs to hospitals resulting from the amendments made by this section. (3) Inspector general report on potentially abusive ownership or compensation arrangements.— The Inspector General of the Department of Health and Human Services shall study and report to Congress, by not later than May 1, 1989, concerning— (A) physician ownership of, or compensation from, an entity providing items or services to which the physician makes referrals and for which payment may be made under the medicare program; (B) the range of such arrangements and the means by which they are marketed to physicians; (C) the potential of such ownership or compensation to influence the decision of a physician regarding referrals and to lead to inappropriate utilization of such items and services; and (D) the practical difficulties involved in enforcement actions against such ownership and compensation arrangements that violate current antikickback provisions. Such report shall include such recommendations as may be appropriate to strengthen current law provisions to prevent program abuse. (d) Certification.— (1) In general.— Section 1835(a)(2) (42 U.S.C. 1395n(a)(2)) is amended— (A) by striking “and” at the end of subparagraph (E); (B) by striking the period at the end of subparagraph (F) and inserting “; and”; and (C) by inserting after subparagraph (F) the following new subparagraph: “(G) in the case of home intravenous drug therapy services, (i) such services are or were required because the individual needed such services for the administration of a covered home IV drug, (ii) a plan for furnishing such services has been established and is reviewed periodically by a physician, (iii) such services are or were furnished while the individual is or was under the care of a physician, (iv) such services are administered in a place of residence used as such individual’s home, and (v) with respect to such services initiated before January 1, 1993, such services have been reviewed and approved by a utilization and peer review organization under section 1154(a)(16) before the date such services were initiated (or, in the case of services first initiated on an outpatient basis, within 1 working day (except in exceptional circumstances) of the date of initiation of the services).”. (2) Pro prior approval required.—Section 1154(a) (42 U.S.C. 1320c–3(a)) is amended by adding at the end the following new paragraph: (16) The organization shall perform the review described in paragraph (1) with respect to home intravenous drug therapy services (as defined in section 1861(jj)(D) initiated before January 1, 1993, within 1 working day of the date of the organization’s receipt of a request for such review. The Secretary shall establish criteria to be used by such an organization in conduct-102 STAT. 725 ing reviews with respect to the appropriateness of home intravenous drug therapy services under this paragraph.”. (e) Certification of Home Intravenous Drug Therapy Providers; Intermediate Sanctions for Noncompliance.— (1) Treatment as provider of services.—Section 1861(u) (42 U.S.C. 1395x(u)) is amended by inserting “home intravenous drug therapy provider,” after “hospice program,”. (2) Consultation with state agencies and other organizations.—Section 1863 (42 U.S.C. 1395z) is amended by striking “and (dd)(2)” and inserting “(dd)(2), and (jj)(3)”. (3) Use of state agencies in determining compliance.— Section 1864(a) (42 U.S.C. 1395aa(a)) is amended— (A) in the first sentence, by inserting “or a home intravenous drug therapy provider,” after “hospice program”, and (B) in the second sentence, by striking “or hospice program” and inserting “hospice program, or home intravenous drug therapy provider”. (4) Application of intermediate sanctions.— Section 1846 (42 U.S.C. 1395w–2) is amended— (A) in the heading, by adding “and for qualified home intravenous drug therapy providers” at the end; (B) in subsection (a), by inserting “or that a qualified home intravenous drug therapy provider that is certified for participation under this title no longer substantially meets the requirements of section 1861(jj)(3)” after “under this part”; and (C) in subsection (b)(2)(A)(iv) by inserting “or home intravenous drug therapy services” after “clinical diagnostic laboratory tests”. (f) Use of Regional Intermediaries in Administration of Benefit.—Section 1816 (42 U.S.C. 1395h) is amended by adding at the end thereof the following new subsection: “(k) With respect to carrying out functions relating to payment for home intravenous drug therapy services and covered home IV drugs, the Secretary may enter into contracts with agencies or organizations under this section to perform such functions on a regional basis.”. (g) Effective Date.—The amendments made by this section shall apply to items and services furnished on or after January 1, 1990.