109 HR 5193 IH: To amend titles XVIII and XIX of the Social Security Act to provide for continuity of Medicare prescription drug coverage for full-benefit dual eligible individuals, for Medicare prescription drug coverage of benzodiazepines and off-label uses of certain prescription drugs and biological products, for optional Medicaid coverage of Medicare prescription drug cost-sharing for full-benefit dual eligible individuals, for authorization to the Secretary of Health and Human Services to waive certain determinations denying Medicare prescription drug coverage, and for holding pharmacies harmless for certain costs incurred during implementation of Medicare part D. U.S. House of Representatives 2006-04-25 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 2d Session H. R. 5193 IN THE HOUSE OF REPRESENTATIVES April 25, 2006 Mrs. Wilson of New Mexico 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 amend titles XVIII and XIX of the Social Security Act to provide for continuity of Medicare prescription drug coverage for full-benefit dual eligible individuals, for Medicare prescription drug coverage of benzodiazepines and off-label uses of certain prescription drugs and biological products, for optional Medicaid coverage of Medicare prescription drug cost-sharing for full-benefit dual eligible individuals, for authorization to the Secretary of Health and Human Services to waive certain determinations denying Medicare prescription drug coverage, and for holding pharmacies harmless for certain costs incurred during implementation of Medicare part D.

1.

Continuity of medicare prescription drug coverage for full-benefit dual eligible individuals

(a)

In general

Section 1860D–2(a) of the Social Security Act (42 U.S.C. 1395w–102(a)) is amended— (1)in paragraph (1), by inserting subject to paragraph (6), after part C; and (2) by adding at the end the following new paragraph: (6)

Continuation of medicare coverage for certain prescriptions for full-benefit dual eligible individuals

In the case of an individual who, as of the date the individual is first enrolled under a prescription drug plan under this part (or an MA–PD plan under part D), is a full-benefit dual eligible individual and is being provided medical assistance for a covered part D drug under title XIX, qualified prescription drug coverage must include coverage for such drug unless a prescribing physician certifies that the coverage of such drug is not medically necessary, regardless of whether the individual subsequently remains a full-benefit dual eligible individual.. (b)

Effective date

The amendments made by subsection (a) shall be effective as if included in the enactment of Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173).

2.

Medicare prescription drug coverage of benzodiazepines

(a)

In general

Section 1860D–2(e)(2)(A) of the Social Security Act (42 U.S.C. 1395w–112(e)(2)(A)) is amended by inserting after agents) the following: and other than subparagraph (J) of such section (relating to benzodiazepines). (b)

Effective date

The amendment made by subsection (a) shall be effective as if included in the enactment of Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173).

3.

Permitting State medicaid programs to cover medicare prescription drug copayments for full-benefit dual eligible individuals

(a)

In general

Section 1935(d) of the Social Security Act (42 U.S.C. 1396u–5(d)) is amended by adding at the end the following new paragraph: (3)

Optional coverage of medicare prescription drug cost-sharing

Notwithstanding paragraph (1), a State may, at its option, provide medical assistance under the plan under this title for the deductible and cost-sharing imposed under a prescription drug plan (or an MA–PD plan) for full-benefit dual eligible individuals and payment shall be available under section 1903(a) with respect to such assistance provided. . (b)

Effective date

The amendment made by subsection (a) shall be effective as if included in the enactment of Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173).

4.

Medicare coverage of off-label uses of prescription drugs and biologicals

(a)

In general

Section 1860D—2(e) of the Social Security Act (42 U.S.C. 1395w–102(e)) is amended at the end by adding the following new paragraph: (4)

Rule of construction

Nothing in this subsection shall be construed as excluding from the definition of the term covered part D drug— (A)a drug described in paragraph (1)(A) on the sole basis that such drug is prescribed by a physician for a use other than a use included in the labeling of such drug pursuant to the approval of the safety and effectiveness of such drug as a prescription drug under section 505 or 507 of the Federal Food, Drug, and Cosmetic Act or approval of such drug under section 505(j) of such Act; or (B)a biological product described in paragraph (1)(B) on the sole basis that such product is prescribed by a physician for a use other than a use included in the labeling of such product pursuant to the licensure of such product under section 351 of the Public Health Service Act; even if the unlabeled use of the drug or product is not included in a standard clinical reference compendia used by clinicians for purposes of providing guidance to such clinicians with respect to unlabeled uses of such a drug or product.. (b)

Effective date

The amendment made by subsection (a) shall be effective as if included in the enactment of Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173).

5.

Authorization for Secretary of Health and Human Services to waive denial of prescription drug coverage

(a)

In general

Section 1860D–4(h) of the Social Security Act (42 U.S.C. 1395w–104(h)) is amended at the end by adding the following new paragraph: (4)

Authorization for Secretary to waive denial of prescription drug coverage

After a part D eligible individual has exhausted all rights of such individual under this subsection and subsection (g), with respect to a determination made under this subsection or subsection (g) for a prescription drug plan not to provide for coverage of a covered part D drug (or a determination related to the application of tiered cost-sharing described in subsection (g)(2)), the individual may apply to the Secretary for a waiver that requires the prescription drug plan to provide for such coverage (or provide for an exception to the structure of such tiered cost-sharing). Upon receipt of such application, the Secretary may grant such waiver if the prescribing physician certifies that the coverage of such prescription drug is medically necessary with respect to the individual.. (b)

Effective date

The amendment made by subsection (a) shall be effective as if included in the enactment of Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108–173).

6.

Holding pharmacies harmless for certain costs incurred during implementation of Medicare part D

(a)

In general

The Secretary of Health and Human Services shall provide for such payments to pharmacies as may be necessary to reimburse pharmacies fully for— (1)transaction fees associated with any point-of-sale facilitated identification and enrollment process established by the Secretary to facilitate, at point of sale, the identification of drug plan assignment of full-benefit dual eligible individuals (as defined in section 1935(c)(6) of the Social Security Act (42 U.S.C. 1396u–5(c)(6)) or the enrollment of previously unidentified or new full-benefit dual eligible individuals into Medicare prescription drug coverage under part D of title XVIII of the Social Security Act; (2)costs associated with technology or software upgrades necessary to make any identification and enrollment inquiries as part of a process described in paragraph (1); and (3)costs of providing prescription drugs and biological products to part D eligible individuals (as defined in section 1860D–1(a)(3)(A) of such Act (42 U.S.C. 1395w–101(a)(3)(A)) whose prescription drug plans could not be identified, if the pharmacy involved was not reimbursed for such costs upon completion of plan reconciliation. (b)

Time

Payments under subsection (a) shall be made with respect to fees and costs incurred during the period beginning on December 1, 2005, and ending on June 1, 2006. (c)

Payments from account

Payments under subsection (a) shall be made from the Medicare Prescription Drug Account under section 1860D–16 of the Social Security Act (42 U.S.C. 1395w–116) and shall be deemed to be payments from such Account under subsection (b) of such section.