Short title; table of contents

(a)

Short title

This Act may be cited as the

Medicare IVIG Access Act of 2007

. (b)

Table of contents

The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Medicare payment for immune globulins.

Sec. 4. Coverage and payment of intravenous immune globulin in the home.

Sec. 5. Patient access surveys and reports.

Findings

(a)

Findings

Congress finds the following: (1)Intravenous immune globulin (IVIG) is a human blood plasma derived product, which over the past 25 years has become an invaluable therapy for many primary immunodeficiency diseases, as well as a number of neurological, autoimmune, and other chronic conditions and illnesses. For many of these disorders, IVIG is the most effective and viable treatment available, and has dramatically improved the quality of life for persons with these conditions and has become a life-saving therapy for many. (2)The Food and Drug Administration (FDA) recognizes each IVIG brand as a unique biologic. The differences in basic fractionation and the addition of various modifications for further purification, stabilization and virus inactivation/removal yield clearly different biological products. As a result, IVIG therapies are not interchangeable, with patient tolerance differing from one IVIG brand to another. (3)The report of the Office of the Assistant Secretary for Planning and Evaluation (ASPE), Department of Health and Human Services (DHHS), Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV), issued in May 2007, found that IVIG manufacturing is complex and requires substantial upfront cash outlay and planning and takes between seven and 12 months from plasma collection at donor centers to FDA lot release. (4)The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 changed Medicare’s reimbursement methodology for IVIG from average wholesale price (AWP) to average sales price plus 6 percent (ASP+6), effective January 1, 2005, for physicians, and January 1, 2006, for hospital outpatient departments, thereby reducing reimbursement rates paid to these providers of IVIG on behalf of Medicare beneficiaries. (5)An Office of the Inspector General (OIG) April 2007 report, Intravenous Immune Globulin: Medicare Payment and Availability, found that Medicare reimbursement for IVIG was inadequate to cover the cost many providers must pay for the product. During the third quarter of 2006, 44 percent of IVIG sales to hospitals and 41 percent of sales to physicians by the three largest distributors occurred at prices above Medicare payment amounts. (6)The ASPE report notes that after the new reimbursement rules for physicians was instituted in 2005, 42 percent of Medicare beneficiaries who had received their IVIG treatment in their physician’s office at the end of 2004 were shifted to the hospital outpatient setting by the beginning of 2006. This shift in site of care has resulted in lack of continuity of care and adverse impact on health outcomes and quality of life. (7)The OIG also reported that 61 percent of responding physicians indicated that they had sent patients to hospitals for IVIG treatment, largely because of their inability to purchase IVIG at prices below the Medicare payment amounts. In addition, OIG found that some physicians had stopped providing IVIG to Medicare beneficiaries altogether. (8)The OIG’s 2007 report concluded that whatever improvement some providers saw in the relationship of Medicare reimbursement for IVIG to prices paid during the first three quarters of 2006 would be eroded if manufacturers were to increase prices for IVIG in the future. (9)The Centers for Medicare & Medicaid Services, in recognition of dislocations experienced by patients and providers in obtaining IVIG since the change to the ASP+6 reimbursement methodology, has provided during 2006 and 2007 a temporary additional payment for IVIG preadministration-related services to compensate physicians and hospital outpatient departments for the extra resources they have had to expend in locating and obtaining appropriate IVIG products and in scheduling patient infusions. (10)Approximately 10,000 Medicare beneficiaries receive IVIG treatment for their primary immunodeficiency disease in a variety of different settings. They have no other effective treatment for their condition. (11)The Medicare Modernization Act of 2003 (MMA) established an IVIG home infusion benefit for persons with primary immunodeficiency disease (PIDD), paying only for IVIG and specifically excluding coverage of items and services related to administration of the product. (12)The ASPE report, Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV), found that Medicare’s IVIG home infusion benefit is not designed to reimburse for more than the cost of IVIG and does not cover the cost of infusion services (for example, nursing and clinical services and supplies) in the home. As a consequence, the report found that home infusion providers generally do not accept new PIDD patients with only Medicare coverage. These limitations in service are caused by health care providers(A)not being able to acquire IVIG at prices at or below the Medicare part B reimbursement level, and(B)not being reimbursed for the infusion services provided by a nurse. (13)Access to home infusion of IVIG for PIDD patients, who have a genetic or intrinsic defect in their human immune system, will reduce their exposure to infections at a time when their antibodies are compromised and will improve the quality of their care and their health.

Medicare payment for immune globulins

(a)

In general

Section 1842(o)(1)(E) of the Social Security Act (42 U.S.C. 1395u(o)(1)(E)) is amended— (1)in paragraph (1)(E)(ii), by inserting before the period the following: , plus an additional amount (if applicable) under paragraph (7); (2)in paragraph (7), by striking (6) and inserting (7) and by redesignating it as paragraph (8); and (3)by inserting after paragraph (6) the following new paragraph:

(7)(A)Not later than 6 months after the date of the enactment of the Medicare IVIG Access Act of 2007, the Secretary shall— (i)collect data on the differences, if any, between payments to physicians for immune globulins under paragraph (1)(E)(ii) and costs incurred by physicians for furnishing these products; and (ii)review available data, including survey data presented by members of the IVIG community on the access of individuals eligible for services under this part to immune globulins. (B)Upon completion of the review and collection of data under subparagraph (A), and not later than 7 months after the date of the enactment of this paragraph, the Secretary shall provide, if appropriate, to physicians furnishing immune globulins, a payment, in addition to the payment provided for in paragraph (1)(E)(ii), for all items related to the furnishing of immune globulins, in an amount that the Secretary determines to be appropriate. (C)In the case of immune globulins furnished on or after January 1, 2007, the Secretary shall continue the preadministration-related services payment established under the Final Physician Fee Schedule Rule issued by the Centers for Medicare & Medicaid Services on November 1, 2006 (CMS–1321–FC), until such time as the Secretary determines that payment for immune globulins is adequate or until a new payment methodology is implemented.

(b)

As part of hospital outpatient services

Section 1833(t)(14) of such Act (42 U.S.C. 1395l(t)(14)) is amended— (1)in subparagraph (A)(iii), by striking subparagraph (E) and inserting subparagraphs (E) and (I); and (2)by adding at the end the following new subparagraph:

(I)

Additional payment for immune globulins

(i)

Data collection and review

Not later than 6 months after the date of the enactment of the Medicare IVIG Access Act of 2007, the Secretary shall— (I)review available data, including survey data presented by members of the IVIG community, on the access of individuals eligible for services under this part to immune globulins; and (II)collect data on the differences, if any, between payments for immune globulins under subparagraph (A)(iii) and costs incurred for furnishing these products. (ii)

Additional payment authority

Upon completion of the review and collection of data under clause (i), and not later than 7 months after the date of the enactment of this subparagraph, the Secretary shall provide, if appropriate, to hospitals furnishing immune globulins as part of a covered OPD service, a payment, in addition to the payment provided for under subparagraph (A)(iii), for all items related to the furnishing of immune globulins, in an amount that the Secretary determines to be appropriate. (iii)

Continuation of special payment rule

In the case of immune globulins furnished on or after January 1, 2007, the Secretary shall continue the preadministration-related services payment established under the Final Hospital Outpatient Rule issued by the Centers for Medicare & Medicaid Services November 1, 2006 (CMS–1506–FC), until such time as the Secretary determines that payment for immune globulins is adequate or until a new payment methodology is implemented.

Coverage and payment of intravenous immune globulin in the home

(a)

Including coverage of administration

(1)

In general

Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— (A)in subsection (s)(2)(Z), by inserting before the semicolon at the end the following: , regardless of whether the individual receiving the globulin is eligible to receive home health services under this title; and (B)in subsection (zz), by striking but not including items or services related to the administration of the derivative. (2)

Conforming home health amendment

Section 1814(a) of such Act (42 U.S.C. 1395f(a)) is amended by adding at the end the following: An individual eligible for intravenous immune globulin under section 1861(s)(2)(Z) shall not be considered eligible for home health services under paragraph (2)(C) or section 1835(a)(2)(A) solely on the basis of meeting the requirements of such subsection or section 1861(zz).. (b)

Payment for intravenous immune globulin administration in the home

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

(n)

Payment for intravenous immune globulin in the home

The Secretary shall review available published and unpublished data and information, including the Study of Intravenous Immune Globulin Administration Options: Safety, Access, and Cost Issues (CMS Contract #500–95–0059), on confirming the appropriateness of administration of intravenous immune globulin in the home setting, and (as appropriate) calculate the amount, in addition to that made under section 1842(o)(1)(E)(ii) for immune globulins, that should be paid to providers for clinical, compliance, and complication management services for ensuring safe and efficacious delivery of immune globulins in the home setting under 1861(s)(2)(Z). The Secretary shall pay such amounts no later than January 1, 2008.

(c)

Application of criminal record request provisions to IVIG in-home providers

Section 124(i)(1) of the Departments of Commerce, Justice, State, the Judiciary, and Related Agencies Appropriations Act, 1999 (as contained in section 1(b) of Public Law 105–277; 112 Stat. 2681–74) is amended by adding at the end the following: Such term includes an entity providing intravenous immune globulin under part B of title XVIII of the Social Security Act in a home.. (d)

Effective date

The amendments made by subsections (a) and (b) shall apply to intravenous immune globulin administered on or after January 1, 2008.

Patient access surveys and reports

(a)

Surveys

The Secretary of Health and Human Services shall conduct, not later than 3 years after the date of the enactment of this Act, two surveys of Medicare and non-Medicare patients who need immune globulins for the purpose of measuring changes in patient access to those products (and providers furnishing those products), as well as changes in the health care status of those patients. The Secretary may enter into contracts with organizations or entities qualified to conduct such surveys. (b)

Survey reports

Each of the surveys shall include a report to the Secretary and the Committees on Energy and Commerce and Ways and Means of the House of Representatives and the Committee on Finance of the Senate on findings from the survey, as well as a discussion of reasons for observed changes, if any. (c)

Congressional reports

On the basis of findings from such surveys, the Secretary shall submit to Congress reports that include recommendations on necessary adjustments in payments for immune globulins under the Medicare program in order to assure beneficiary access to those products and providers that furnish those products. The first such report shall be submitted no later than 2 years after the date of the enactment of this Act and the second report no later than four years after such date.