II 

110TH CONGRESS 

1ST SESSION S. 1887 

To amend title XVIII of the Social Security Act in order to ensure access 

to critical medications under the Medicare part D prescription drug program. 

IN THE SENATE OF THE UNITED STATES 

JULY 26, 2007 

Mr. SMITH (for himself and Mr. KERRY) introduced the following bill; which 

was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act in order 

to ensure access to critical medications under the Medicare part D prescription drug program. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Access to 

5 Critical Medications Act of 2007’’. 

6 SEC. 2. FORMULARY REQUIREMENTS WITH RESPECT TO 

7 CERTAIN CATEGORIES AND CLASSES OF 

8 DRUGS. 

9 (a) REQUIRED INCLUSION OF DRUGS IN CERTAIN

10 CATEGORIES AND CLASSES.— 


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1 (1) INITIAL LIST.—Section 1860D–4(b)(3) of 

2 the Social Security Act (42 U.S.C. 1395w– 

3 104(b)(3)) is amended— 

4 (A) in subparagraph (C)(i), by striking 

5 ‘‘The formulary’’ and inserting ‘‘Subject to sub6 paragraph (G), the formulary’’; and 

7 (B) by inserting after subparagraph (F) 

8 the following new subparagraph: 

9 ‘‘(G) INITIAL LIST OF REQUIRED DRUGS IN

10 CERTAIN CATEGORIES AND CLASSES.— 

11 ‘‘(i) IN GENERAL.—Subject to clause 

12 (iv), the formulary must include all or sub13 stantially all drugs in the following cat14 egories and classes that are available as of 

15 April 30 of the year prior to the year 

16 which includes the date of enactment of 

17 the Medicare Access to Critical Medica18 tions Act of 2007: 

19 ‘‘(I) Immunosuppressant. 

20 ‘‘(II) Antidepressant. 

21 ‘‘(III) Antipsychotic. 

22 ‘‘(IV) Anticonvulsant. 

23 ‘‘(V) Antiretroviral. 

24 ‘‘(VI) Antineoplastic. 

25 ‘‘(ii) NEWLY APPROVED DRUGS.— 


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1 ‘‘(I) IN GENERAL.—In the case 

2 of a drug in any of the categories and 

3 classes described in subclauses (I) 

4 through (VI) of clause (i) that be5 comes available after the April 30 

6 date described in clause (i), the for7 mulary shall include such drug within 

8 30 days of the drug becoming avail9 able, except that, in the case of such 

10 a drug that becomes available during 

11 the period beginning on such April 30 

12 and ending on the date of enactment 

13 of the Medicare Access to Critical 

14 Medications Act of 2007, the for15 mulary shall include such drug within 

16 30 days of such date of enactment. 

17 ‘‘(II) USE OF FORMULARY MAN18 AGEMENT PRACTICES AND POLI19 CIES.—Nothing in this clause shall be 

20 construed as preventing the Pharmacy 

21 and Therapeutic Committee of a PDP 

22 sponsor from advising such sponsor 

23 on the clinical appropriateness of uti24 lizing formulary management prac25 tices and policies with respect to a 


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1 newly approved drug that is required 

2 to be included on the formulary under 

3 subclause (I). 

4 ‘‘(iii) UNIQUE DOSAGES AND

5 FORMS.—A PDP sponsor of a prescription 

6 drug plan shall include coverage of all 

7 unique dosages and forms of drugs re8 quired to be included on the formulary 

9 pursuant to clause (i) or (ii). 

10 ‘‘(iv) SUNSET.—The provisions of this 

11 subparagraph shall not apply after Decem12 ber 31 of the year which includes the date 

13 that is 5 years after the date of enactment 

14 of the Medicare Access to Critical Medica15 tions Act of 2007.’’ 

16 (2) REVIEW OF DRUGS COVERED UNDER THE

17 MEDICARE PART D PRESCRIPTION DRUG PRO18 GRAM.—Section 1860D–4(b)(3) of the Social Secu19 rity Act (42 U.S.C. 1395w–104(b)(3)), as amended 

20 by paragraph (1), is amended— 

21 (A) in subparagraph (C)(i), by striking 

22 ‘‘subparagraph (G)’’ and inserting ‘‘subpara23 graphs (G) and (H)’’; and 

24 (B) by inserting after subparagraph (G) 

25 the following new subparagraph: 


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1 ‘‘(H) REQUIRED INCLUSION OF DRUGS IN

2 CERTAIN CATEGORIES AND CLASSES.— 

3 ‘‘(i) REQUIRED INCLUSION OF DRUGS

4 IN CERTAIN CATEGORIES AND CLASSES.— 

5 ‘‘(I) IN GENERAL.—Beginning 

6 January 1 of the year after the year 

7 which includes the date that is 5 years 

8 after the date of enactment of the 

9 Medicare Access to Critical Medica10 tions Act of 2007, PDP sponsors of11 fering prescription drug plans shall be 

12 required to include all unique dosages 

13 and forms of all or substantially all 

14 drugs in certain categories and class15 es, including the categories and class16 es described in subclauses (I) through 

17 (VI) of subparagraph (G)(i), on the 

18 formulary of such plans within 30 

19 days of the drug becoming available. 

20 ‘‘(II) REGULATIONS.—Not later 

21 than January 1 of the year after the 

22 year which includes the date that is 4 

23 years after the date of enactment of 

24 the Medicare Access to Critical Medi25 cations Act of 2007, the Secretary 


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1 shall issue regulations to carry out 

2 this clause. 

3 ‘‘(ii) PERIODIC REVIEW.—The Sec4 retary shall establish procedures to provide 

5 for periodic review of the drugs required to 

6 be included on the formulary under clause 

7 (i). 

8 ‘‘(iii) UPDATING.— 

9 ‘‘(I) IN GENERAL.—The Sec10 retary may update the list of drugs 

11 required to be included on the for12 mulary under clause (i) if the Sec13 retary determines, in accordance with 

14 this clause, that updating such list is 

15 appropriate. 

16 ‘‘(II) ADDING CATEGORIES OR

17 CLASSES.—In issuing the regulations 

18 under clause (i) and updating the list 

19 in order to add a drug in a category 

20 or class to the list of drugs required 

21 to be included on the formulary under 

22 such clause, the Secretary shall con23 sider factors that justify requiring 

24 coverage of drugs in a certain cat25 egory or class, including the following: 


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1 ‘‘(aa) Whether the drugs in 

2 a category or class are used to 

3 treat a disease or disorder that 

4 can cause significant negative 

5 clinical outcomes to individuals in 

6 a short timeframe. 

7 ‘‘(bb) Whether there are 

8 special or unique benefits with 

9 respect to the majority of drugs 

10 in a given category or class. 

11 ‘‘(cc) High predicted drug 

12 and medical costs for the dis13 eases or disorders treated by the 

14 drugs in a given category or 

15 class. 

16 ‘‘(dd) Whether restricted ac17 cess to the drugs in the category 

18 or class has major clinical con19 sequences for individuals enrolled 

20 in a prescription drug plan who 

21 have a disease or disorder treated 

22 by the drugs in such category or 

23 class. 

24 ‘‘(ee) The potential for the 

25 development of discriminatory 


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1 formulary policies based on the 

2 clinical or functional characteris3 tics of such individuals and the 

4 high cost of certain drugs in a 

5 category or class. 

6 ‘‘(ff) The need for access to 

7 multiple drugs within a category 

8 or class due to the unique chem9 ical action and pharmacological 

10 effects of drugs within the cat11 egory or class and any variation 

12 in clinical response based on dif13 ferences in such individuals’ me14 tabolism, age, gender, ethnicity, 

15 comorbidities, drug-resistance, 

16 and severity of disease. 

17 ‘‘(gg) Any applicable revi18 sions that have been made to 

19 widely-accepted clinical practice 

20 guidelines endorsed by pertinent 

21 medical specialty organizations. 

22 ‘‘(III) REMOVAL OF CATEGORIES

23 OR CLASSES.—In updating the list in 

24 order to remove a drug in a category 

25 or class from the list of drugs reVerDate Aug 31 2005 05:44 Jul 27, 2007 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1887.IS S1887

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1 quired to be included on the formulary 

2 under clause (i), the Secretary may 

3 remove a drug from such list in the 

4 case where the Secretary determines 

5 that widely-accepted clinical practice 

6 guidelines endorsed by pertinent na7 tional medical specialty organizations 

8 indicate that, for substantially all 

9 drugs in the category or class, re10 stricting access to such drugs is un11 likely to result in adverse clinical con12 sequences for individuals with condi13 tions for which the drugs are clinically 

14 indicated.’’. 

15 (b) LIMITATION OF UTILIZATION MANAGEMENT

16 TOOLS FOR DRUGS IN CERTAIN CATEGORIES AND CLASS17 ES.—Section 1860D–4(c) of the Social Security Act (42 

18 U.S.C. 1395w–104(c)) is amended— 

19 (1) in paragraph (1)(A), by striking ‘‘A cost-ef20 fective’’ and inserting ‘‘Subject to paragraph (3), a 

21 cost-effective’’; and 

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

23 paragraph: 


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1 ‘‘(3) LIMITATION OF UTILIZATION MANAGE2 MENT TOOLS FOR DRUGS IN CERTAIN CATEGORIES

3 AND CLASSES.— 

4 ‘‘(A) IN GENERAL.—A PDP sponsor of a 

5 prescription drug plan may not apply a utiliza6 tion management tool, such as prior authoriza7 tion or step therapy, to the following: 

8 ‘‘(i) During the period beginning on 

9 the date of enactment of this paragraph 

10 and ending on December 31 of the year 

11 which includes the date that is 5 years 

12 after such date of enactment— 

13 ‘‘(I) a drug in a category or class 

14 described in subsection 

15 (b)(3)(G)(i)(V); and 

16 ‘‘(II) a drug in a category or 

17 class described in subclause (I), (II), 

18 (III), (IV), or (VI) of subsection 

19 (b)(3)(G)(i) in the case where an en20 rollee was engaged in a treatment reg21 imen using such drug in the 90-day 

22 period prior to the date on which such 

23 tool would be applied to the drug with 

24 respect to the enrollee under the plan 

25 or the PDP sponsor is unable to deVerDate Aug 31 2005 05:44 Jul 27, 2007 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1887.IS S1887

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1 termine if the enrollee was engaged in 

2 such a treatment regimen prior to 

3 such date. 

4 ‘‘(ii) Beginning January 1 of the year 

5 after the year which includes the date that 

6 is 5 years after the date of enactment of 

7 this paragraph— 

8 ‘‘(I) a drug in a category or class 

9 described in subsection 

10 (b)(3)(G)(i)(V), if such drug is re11 quired to be included on the formulary 

12 under subsection (b)(3)(H); and 

13 ‘‘(II) a drug in any other cat14 egory or class required to be included 

15 on the formulary under subsection 

16 (b)(3)(H) in the case where an en17 rollee was engaged in a treatment reg18 imen using such drug in the 90-day 

19 period prior to the date on which such 

20 tool would be applied to the drug with 

21 respect to the enrollee under the plan 

22 or the PDP sponsor is unable to de23 termine if the enrollee was engaged in 

24 such a treatment regimen prior to 

25 such date. 


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1 ‘‘(B) STATEMENT OF EVIDENCE BASE FOR

2 APPLICATION OF UTILIZATION MANAGEMENT

3 TOOL.—In the case where a utilization manage4 ment tool is applied to a drug in a category or 

5 class required to be included on a plan for6 mulary under subparagraph (G) or (H) of sub7 section (b)(3), the PDP sponsor of such plan 

8 shall provide a statement of the evidence base 

9 substantiating the clinical appropriateness of 

10 the application of such tool.’’. 

11 (c) RULE OF CONSTRUCTION.—Nothing in the provi12 sions of this section, or the amendments made by this sec13 tion, shall be construed as prohibiting the Secretary of 

14 Health and Human Services from issuing guidance or reg15 ulations to establish formulary or utilization management 

16 requirements under section 1860D–4 of the Social Secu17 rity Act (42 U.S.C. 1395w–104) as long as they do not 

18 conflict with such provisions and amendments. 

19 (d) EFFECTIVE DATE.—The amendments made by 

20 this section shall apply to contract years beginning on or 

21 after January 1, 2008. 

22 SEC. 3. APPEALS REQUIREMENTS FOR CERTAIN CAT23 EGORIES AND CLASSES OF DRUGS. 

24 (a) COVERAGE DETERMINATIONS AND RECONSIDER25 ATION.—Section 1860D–4(g) of the Social Security Act 


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1 (42 U.S.C. 1395w–104(g)) is amended by adding at the 

2 end the following new paragraph: 

3 ‘‘(3) REQUEST FOR ADETERMINATION OR RE4 CONSIDERATION FOR THE TREATMENT OF DRUGS IN

5 CERTAIN CATEGORIES AND CLASSES.— 

6 ‘‘(A) IN GENERAL.—In the case where an 

7 individual enrolled in a prescription drug plan 

8 disputes a utilization management requirement, 

9 an adverse coverage determination, a reconsid10 eration by a PDP sponsor of a prescription 

11 drug plan, or an adverse reconsideration by an 

12 Independent Review Entity with respect to a 

13 covered part D drug in the categories and class14 es required to be included on the formulary 

15 under subparagraph (G) of subsection (b)(3) or 

16 under the regulations issued under subpara17 graph (H) of such subsection, the PDP sponsor 

18 shall continue to cover such prescription drug 

19 until the date that is not less that 60 days after 

20 the latest of the following has occurred: 

21 ‘‘(i) The enrollee has received written 

22 notice of an adverse reconsideration by a 

23 PDP sponsor. 

24 ‘‘(ii) In the case where an enrollee has 

25 requested reconsideration by an IndeVerDate Aug 31 2005 05:44 Jul 27, 2007 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1887.IS S1887

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1 pendent Review Entity, such Entity has 

2 issued an adverse reconsideration. 

3 ‘‘(iii) In the case where an appeal of 

4 such adverse reconsideration has been filed 

5 by the individual, an administrative law 

6 judge has decided or dismissed the appeal. 

7 ‘‘(B) DEFINITION OF INDEPENDENT RE8 VIEW ENTITY.—In this paragraph, the term 

9 ‘Independent Review Entity’ means the inde10 pendent, outside entity the Secretary contracts 

11 with under section 1852(g)(4), including such 

12 an entity that the Secretary contracts with in 

13 order to meet the requirements of such section 

14 under section 1860D–4(h)(1).’’. 

15 (b) APPEALS.—Section 1860D–4(h) of the Social Se16 curity Act (42 U.S.C. 1395w–104(h)) is amended— 

17 (1) in paragraph (2), by striking ‘‘A part D’’ 

18 and inserting ‘‘Subject to paragraph (4), a part D’’; 

19 and 

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

21 paragraph: 

22 ‘‘(4) TREATMENT OF APPEALS FOR DRUGS IN

23 CERTAIN CATEGORIES AND CLASSES.— 

24 ‘‘(A) IN GENERAL.—A part D eligible indi25 vidual who is enrolled in a prescription drug 


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1 plan offered by a PDP sponsor may appeal 

2 under paragraph (1) a determination by such 

3 sponsor not to provide coverage of a covered 

4 part D drug in a category or class required to 

5 be included on the formulary under subpara6 graph (G) of subsection (b)(3) or under the reg7 ulations issued under subparagraph (H) of such 

8 subsection at any time after such determination 

9 by requesting a reconsideration by an Inde10 pendent Review Entity. 

11 ‘‘(B) DEFINITION OF INDEPENDENT RE12 VIEW ENTITY.—In this paragraph, the term 

13 ‘Independent Review Entity’ has the meaning 

14 given such term in subsection (g)(3)(B).’’. 

15 (c) EFFECTIVE DATE.—The amendments made by 

16 this section shall apply to contract years beginning on or 

17 after January 1, 2008. 

18 SEC. 4. DATA REPORTING REQUIREMENTS FOR CERTAIN 

19 CATEGORIES AND CLASSES OF DRUGS 

20 UNDER THE MEDICARE PART D PRESCRIP21 TION DRUG PROGRAM. 

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

23 Security Act (42 U.S.C. 1395w–104) is amended by add24 ing at the end the following new subsection: 


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1 ‘‘(l) DATA REPORTING FOR CERTAIN CATEGORIES

2 AND CLASSES OF DRUGS.— 

3 ‘‘(1) IN GENERAL.—A PDP sponsor offering a 

4 prescription drug plan shall disclose to the Secretary 

5 (in a manner specified by the Secretary) data at the 

6 plan level on the number of— 

7 ‘‘(A) favorable and adverse decisions made 

8 with respect to exceptions requested to for9 mulary policies— 

10 ‘‘(i) during the period beginning on 

11 the date of enactment of this subsection 

12 and ending on December 31 of the year 

13 which includes the date that is 5 years 

14 after such date of enactment, for each of 

15 the categories and classes of drugs de16 scribed in subclauses (I) through (VI) of 

17 subsection (b)(3)(G)(i); and 

18 ‘‘(ii) beginning January 1 of the year 

19 after the year which includes the date that 

20 is 5 years after such date of enactment, for 

21 each of the categories and classes of drugs 

22 required to be included on the formulary 

23 under the regulations issued under sub24 section (b)(3)(H); 


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1 ‘‘(B) favorable and adverse coverage deter2 minations made with respect to each of such 

3 categories and classes during the applicable pe4 riod; 

5 ‘‘(C) favorable and adverse reconsider6 ations made by a PDP sponsor with respect to 

7 each of such categories and classes during the 

8 applicable period; 

9 ‘‘(D) favorable and adverse reconsider10 ations made by an Independent Review Entity 

11 (as defined in subsection (g)(3)(B)) with re12 spect to each of such categories and classes 

13 during the applicable period; and 

14 ‘‘(E) appeals made to an administrative 

15 law judge and the decisions made on such ap16 peals with respect to each of such categories 

17 and classes during the applicable period. 

18 ‘‘(2) ANNUAL REPORT.—The Secretary shall— 

19 ‘‘(A) submit an annual report to Congress 

20 containing the data disclosed to the Secretary 

21 under paragraph (1); and 

22 ‘‘(B) publish such report in the Federal 

23 Register.’’. 


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

2 subsection (a) shall apply to contract years beginning on 

3 or after January 1, 2008. 

Æ 


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