Consolidation of Medicare coverage of home infusion therapy under part B

(a)

In general

Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— (1)in subsection (s)(2)— (A)by striking and at the end of subparagraph (Z); (B)by adding and at the end of subparagraph (AA); and (C)by adding at the end the following new subparagraph:

(BB)home infusion therapy (as defined in subsection (ccc)(1));

; and

(2)by adding at the end the following new subsection:

(ccc)

Home infusion therapy

(1)The term home infusion therapy means the following items and services furnished to an individual, who is under the care of a physician, which are provided, except as provided in subparagraph (B), by a qualified home infusion therapy provider under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a physician, which items and services are provided in an integrated manner in the individual’s home in conformance with clinical standards of care established by the Secretary (after taking into account the standards commonly used for home infusion therapy by Medicare Advantage organizations and accreditation organizations)— (A)infusion drugs (as defined in paragraph (2)(B)); (B)nursing services provided, directly or by an accredited homecare organization under arrangements made, by the qualified home infusion therapy provider, in connection with such infusion; and (C)other professional services (including pharmacy and care coordination services) and related items and services (including medical supplies, intravenous fluids, home delivery, equipment, and other items and services the Secretary determines appropriate) to administer infusion drug therapies to an individual safely and effectively in the home;

except that such term does not include nursing services to the extent they are covered as home health services.

(2)For purposes of paragraph (1): (A)The term home means a place of residence used as an individual’s home and includes such alternate settings as the Secretary determines. (B)The term infusion drugs means parenteral drugs and biologicals administered via an intravenous, intraspinal, intra-arterial, intrathecal, subcutaneous, or intramuscular access device inserted into the body. (C)The term qualified home infusion therapy provider means any pharmacy that— (i)has expertise in the preparation of compounded sterile preparations in compliance with enforceable standards of the U.S. Pharmacopoeia or other nationally recognized standards that regulate compounding of sterile preparations as determined by the Secretary; (ii)provides infusion therapy to patients with acute or chronic conditions requiring parenteral administration of drugs and biologicals administered through catheters or needles, or both, in a home; and (iii)meets such requirements as the Secretary determines are necessary to ensure the safe and effective provision of home infusion therapy (taking into account the standards of care for home infusion therapy established by private payers).

(b)

Payment for home infusion therapy

(1)

In general

Section 1834 of such Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

(n)

Payment for home infusion therapy

The payment amount under this part for home infusion therapy is determined as follows: (1)

In general

Except as provided in this subsection, the Secretary shall determine a per diem schedule for payment for home infusion therapy (including pharmacy services, administration services, care coordination services, supplies and equipment necessary to safely and properly administer a home infusion drug or biological in accordance with the requirements and clinical standards commonly used for home infusion therapy) which reflects the reasonable costs which must be incurred by efficiently and economically operated qualified home infusion therapy providers to provide such therapy in conformity with applicable State and Federal laws, regulations, and quality and safety standards and to assure that Medicare beneficiaries have reasonable access to such therapy. (2)

Infusion drugs

(A)

In general

Except as provided in subparagraph (B), the provisions of section 1847A shall apply to payment under this part for drugs included in home infusion therapy. (B)

Special rule

In applying subparagraph (A), the determination of average sales prices under section 1847A shall be limited to such prices for infusion drug sales to home infusion therapy pharmacies.

(2)

Conforming amendments

(A)Section 1833(a)(1) of such Act (42 U.S.C. 1395l(a)(1)) is amended by striking and before (V) and by inserting before the semicolon at the end the following: , and (W) with respect to home infusion therapy, the amounts paid shall be determined under section 1834(n). (B)The first sentence of section 1842(b)(6) of such Act (42 U.S.C. 1395u(b)(6)) is amended by striking and before (H) and by inserting before the period at the end the following: , and (I) in the case of home infusion therapy, payment shall be made to the qualified home infusion therapy provider responsible for furnishing the therapy. (c)

Other conforming provisions

(1)

Exclusion from durable medical equipment benefit

Section 1861(n) of such Act (42 U.S.C. 1395x(n)) is amended by adding at the end the following: Such term does not include home infusion therapy.. (2)

Application of accreditation organization provisions

The provisions of section 1865(b) of the Social Security Act apply to accreditation of qualified home infusion therapy providers. (d)

Effective date

The amendments made by this section shall apply to home infusion therapy furnished on or after January 1, 2007.