I 

109TH CONGRESS 

2D SESSION H. R. 5193 

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. 

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 deterVerDate Aug 31 2005 08:36 Apr 28, 2006 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H5193.IH H5193

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minations denying Medicare prescription drug coverage, 

and for holding pharmacies harmless for certain costs 

incurred during implementation of Medicare part D. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. CONTINUITY OF MEDICARE PRESCRIPTION 

4 DRUG COVERAGE FOR FULL-BENEFIT DUAL 

5 ELIGIBLE INDIVIDUALS. 

6 (a) IN GENERAL.—Section 1860D–2(a) of the Social 

7 Security Act (42 U.S.C. 1395w–102(a)) is amended— 

8 (1) in paragraph (1), by inserting ‘‘subject to 

9 paragraph (6),’’ after ‘‘part C’’; and 

10 (2) by adding at the end the following new 

11 paragraph: 

12 ‘‘(6) CONTINUATION OF MEDICARE COVERAGE

13 FOR CERTAIN PRESCRIPTIONS FOR FULL-BENEFIT

14 DUAL ELIGIBLE INDIVIDUALS.—In the case of an in15 dividual who, as of the date the individual is first 

16 enrolled under a prescription drug plan under this 

17 part (or an MA–PD plan under part D), is a full18 benefit dual eligible individual and is being provided 

19 medical assistance for a covered part D drug under 

20 title XIX, qualified prescription drug coverage must 

21 include coverage for such drug unless a prescribing 

22 physician certifies that the coverage of such drug is 

23 not medically necessary, regardless of whether the 


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1 individual subsequently remains a full-benefit dual 

2 eligible individual.’’. 

3 (b) EFFECTIVE DATE.—The amendments made by 

4 subsection (a) shall be effective as if included in the enact5 ment of Medicare Prescription Drug, Improvement, and 

6 Modernization Act of 2003 (Public Law 108–173). 

7 SEC. 2. MEDICARE PRESCRIPTION DRUG COVERAGE OF 

8 BENZODIAZEPINES. 

9 (a) IN GENERAL.—Section 1860D–2(e)(2)(A) of the 

10 Social Security Act (42 U.S.C. 1395w–112(e)(2)(A)) is 

11 amended by inserting after ‘‘agents)’’ the following: ‘‘and 

12 other than subparagraph (J) of such section (relating to 

13 benzodiazepines)’’. 

14 (b) EFFECTIVE DATE.—The amendment made by 

15 subsection (a) shall be effective as if included in the enact16 ment of Medicare Prescription Drug, Improvement, and 

17 Modernization Act of 2003 (Public Law 108–173). 

18 SEC. 3. PERMITTING STATE MEDICAID PROGRAMS TO 

19 COVER MEDICARE PRESCRIPTION DRUG CO20 PAYMENTS FOR FULL-BENEFIT DUAL ELIGI21 BLE INDIVIDUALS. 

22 (a) IN GENERAL.—Section 1935(d) of the Social Se23 curity Act (42 U.S.C. 1396u–5(d)) is amended by adding 

24 at the end the following new paragraph: 


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1 ‘‘(3) OPTIONAL COVERAGE OF MEDICARE PRE2 SCRIPTION DRUG COST-SHARING.—Notwithstanding 

3 paragraph (1), a State may, at its option, provide 

4 medical assistance under the plan under this title for 

5 the deductible and cost-sharing imposed under a 

6 prescription drug plan (or an MA–PD plan) for full7 benefit dual eligible individuals and payment shall be 

8 available under section 1903(a) with respect to such 

9 assistance provided. ’’. 

10 (b) EFFECTIVE DATE.—The amendment made by 

11 subsection (a) shall be effective as if included in the enact12 ment of Medicare Prescription Drug, Improvement, and 

13 Modernization Act of 2003 (Public Law 108–173). 

14 SEC. 4. MEDICARE COVERAGE OF OFF-LABEL USES OF PRE15 SCRIPTION DRUGS AND BIOLOGICALS. 

16 (a) IN GENERAL.—Section 1860D—2(e) of the So17 cial Security Act (42 U.S.C. 1395w–102(e)) is amended 

18 at the end by adding the following new paragraph: 

19 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this sub20 section shall be construed as excluding from the definition 

21 of the term ‘covered part D drug’— 

22 ‘‘(A) a drug described in paragraph (1)(A) on 

23 the sole basis that such drug is prescribed by a phy24 sician for a use other than a use included in the la25 beling of such drug pursuant to the approval of the 


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1 safety and effectiveness of such drug as a prescrip2 tion drug under section 505 or 507 of the Federal 

3 Food, Drug, and Cosmetic Act or approval of such 

4 drug under section 505(j) of such Act; or 

5 ‘‘(B) a biological product described in para6 graph (1)(B) on the sole basis that such product is 

7 prescribed by a physician for a use other than a use 

8 included in the labeling of such product pursuant to 

9 the licensure of such product under section 351 of 

10 the Public Health Service Act; 

11 even if the unlabeled use of the drug or product is not 

12 included in a standard clinical reference compendia used 

13 by clinicians for purposes of providing guidance to such 

14 clinicians with respect to unlabeled uses of such a drug 

15 or product.’’. 

16 (b) EFFECTIVE DATE.—The amendment made by 

17 subsection (a) shall be effective as if included in the enact18 ment of Medicare Prescription Drug, Improvement, and 

19 Modernization Act of 2003 (Public Law 108–173). 

20 SEC. 5. AUTHORIZATION FOR SECRETARY OF HEALTH AND 

21 HUMAN SERVICES TO WAIVE DENIAL OF PRE22 SCRIPTION DRUG COVERAGE. 

23 (a) IN GENERAL.—Section 1860D–4(h) of the Social 

24 Security Act (42 U.S.C. 1395w–104(h)) is amended at the 

25 end by adding the following new paragraph: 


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1 ‘‘(4) AUTHORIZATION FOR SECRETARY TO WAIVE

2 DENIAL OF PRESCRIPTION DRUG COVERAGE.—After a 

3 part D eligible individual has exhausted all rights of such 

4 individual under this subsection and subsection (g), with 

5 respect to a determination made under this subsection or 

6 subsection (g) for a prescription drug plan not to provide 

7 for coverage of a covered part D drug (or a determination 

8 related to the application of tiered cost-sharing described 

9 in subsection (g)(2)), the individual may apply to the Sec10 retary for a waiver that requires the prescription drug 

11 plan to provide for such coverage (or provide for an excep12 tion to the structure of such tiered cost-sharing). Upon 

13 receipt of such application, the Secretary may grant such 

14 waiver if the prescribing physician certifies that the cov15 erage of such prescription drug is medically necessary with 

16 respect to the individual.’’. 

17 (b) EFFECTIVE DATE.—The amendment made by 

18 subsection (a) shall be effective as if included in the enact19 ment of Medicare Prescription Drug, Improvement, and 

20 Modernization Act of 2003 (Public Law 108–173). 

21 SEC. 6. HOLDING PHARMACIES HARMLESS FOR CERTAIN 

22 COSTS INCURRED DURING IMPLEMENTATION 

23 OF MEDICARE PART D. 

24 (a) IN GENERAL.—The Secretary of Health and 

25 Human Services shall provide for such payments to pharVerDate Aug 31 2005 08:36 Apr 28, 2006 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5193.IH H5193

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1 macies as may be necessary to reimburse pharmacies fully 

2 for— 

3 (1) transaction fees associated with any point4 of-sale facilitated identification and enrollment proc5 ess established by the Secretary to facilitate, at 

6 point of sale, the identification of drug plan assign7 ment of full-benefit dual eligible individuals (as de8 fined in section 1935(c)(6) of the Social Security 

9 Act (42 U.S.C. 1396u–5(c)(6)) or the enrollment of 

10 previously unidentified or new full-benefit dual eligi11 ble individuals into Medicare prescription drug cov12 erage under part D of title XVIII of the Social Secu13 rity Act; 

14 (2) costs associated with technology or software 

15 upgrades necessary to make any identification and 

16 enrollment inquiries as part of a process described in 

17 paragraph (1); and 

18 (3) costs of providing prescription drugs and bi19 ological products to part D eligible individuals (as 

20 defined in section 1860D–1(a)(3)(A) of such Act (42 

21 U.S.C. 1395w–101(a)(3)(A)) whose prescription 

22 drug plans could not be identified, if the pharmacy 

23 involved was not reimbursed for such costs upon 

24 completion of plan reconciliation. 


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1 (b) TIME.—Payments under subsection (a) shall be 

2 made with respect to fees and costs incurred during the 

3 period beginning on December 1, 2005, and ending on 

4 June 1, 2006. 

5 (c) PAYMENTS FROM ACCOUNT.—Payments under 

6 subsection (a) shall be made from the Medicare Prescrip7 tion Drug Account under section 1860D–16 of the Social 

8 Security Act (42 U.S.C. 1395w–116) and shall be deemed 

9 to be payments from such Account under subsection (b) 

10 of such section. 

Æ 


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