[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1887 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Access to Critical 
Medications Act of 2007''.

SEC. 2. FORMULARY REQUIREMENTS WITH RESPECT TO CERTAIN CATEGORIES AND 
              CLASSES OF DRUGS.

    (a) Required Inclusion of Drugs in Certain Categories and 
Classes.--
            (1) Initial list.--Section 1860D-4(b)(3) of the Social 
        Security Act (42 U.S.C. 1395w-104(b)(3)) is amended--
                    (A) in subparagraph (C)(i), by striking ``The 
                formulary'' and inserting ``Subject to subparagraph 
                (G), the formulary''; and
                    (B) by inserting after subparagraph (F) the 
                following new subparagraph:
                    ``(G) Initial list of required drugs in certain 
                categories and classes.--
                            ``(i) In general.--Subject to clause (iv), 
                        the formulary must include all or substantially 
                        all drugs in the following categories and 
                        classes that are available as of April 30 of 
                        the year prior to the year which includes the 
                        date of enactment of the Medicare Access to 
                        Critical Medications Act of 2007:
                                    ``(I) Immunosuppressant.
                                    ``(II) Antidepressant.
                                    ``(III) Antipsychotic.
                                    ``(IV) Anticonvulsant.
                                    ``(V) Antiretroviral.
                                    ``(VI) Antineoplastic.
                            ``(ii) Newly approved drugs.--
                                    ``(I) In general.--In the case of a 
                                drug in any of the categories and 
                                classes described in subclauses (I) 
                                through (VI) of clause (i) that becomes 
                                available after the April 30 date 
                                described in clause (i), the formulary 
                                shall include such drug within 30 days 
                                of the drug becoming available, except 
                                that, in the case of such a drug that 
                                becomes available during the period 
                                beginning on such April 30 and ending 
                                on the date of enactment of the 
                                Medicare Access to Critical Medications 
                                Act of 2007, the formulary shall 
                                include such drug within 30 days of 
                                such date of enactment.
                                    ``(II) Use of formulary management 
                                practices and policies.--Nothing in 
                                this clause shall be construed as 
                                preventing the Pharmacy and Therapeutic 
                                Committee of a PDP sponsor from 
                                advising such sponsor on the clinical 
                                appropriateness of utilizing formulary 
                                management practices and policies with 
                                respect to a newly approved drug that 
                                is required to be included on the 
                                formulary under subclause (I).
                            ``(iii) Unique dosages and forms.--A PDP 
                        sponsor of a prescription drug plan shall 
                        include coverage of all unique dosages and 
                        forms of drugs required to be included on the 
                        formulary pursuant to clause (i) or (ii).
                            ``(iv) Sunset.--The provisions of this 
                        subparagraph shall not apply after December 31 
                        of the year which includes the date that is 5 
                        years after the date of enactment of the 
                        Medicare Access to Critical Medications Act of 
                        2007.''
            (2) Review of drugs covered under the medicare part d 
        prescription drug program.--Section 1860D-4(b)(3) of the Social 
        Security Act (42 U.S.C. 1395w-104(b)(3)), as amended by 
        paragraph (1), is amended--
                    (A) in subparagraph (C)(i), by striking 
                ``subparagraph (G)'' and inserting ``subparagraphs (G) 
                and (H)''; and
                    (B) by inserting after subparagraph (G) the 
                following new subparagraph:
                    ``(H) Required inclusion of drugs in certain 
                categories and classes.--
                            ``(i) Required inclusion of drugs in 
                        certain categories and classes.--
                                    ``(I) In general.--Beginning 
                                January 1 of the year after the year 
                                which includes the date that is 5 years 
                                after the date of enactment of the 
                                Medicare Access to Critical Medications 
                                Act of 2007, PDP sponsors offering 
                                prescription drug plans shall be 
                                required to include all unique dosages 
                                and forms of all or substantially all 
                                drugs in certain categories and 
                                classes, including the categories and 
                                classes described in subclauses (I) 
                                through (VI) of subparagraph (G)(i), on 
                                the formulary of such plans within 30 
                                days of the drug becoming available.
                                    ``(II) Regulations.--Not later than 
                                January 1 of the year after the year 
                                which includes the date that is 4 years 
                                after the date of enactment of the 
                                Medicare Access to Critical Medications 
                                Act of 2007, the Secretary shall issue 
                                regulations to carry out this clause.
                            ``(ii) Periodic review.--The Secretary 
                        shall establish procedures to provide for 
                        periodic review of the drugs required to be 
                        included on the formulary under clause (i).
                            ``(iii) Updating.--
                                    ``(I) In general.--The Secretary 
                                may update the list of drugs required 
                                to be included on the formulary under 
                                clause (i) if the Secretary determines, 
                                in accordance with this clause, that 
                                updating such list is appropriate.
                                    ``(II) Adding categories or 
                                classes.--In issuing the regulations 
                                under clause (i) and updating the list 
                                in order to add a drug in a category or 
                                class to the list of drugs required to 
                                be included on the formulary under such 
                                clause, the Secretary shall consider 
                                factors that justify requiring coverage 
                                of drugs in a certain category or 
                                class, including the following:
                                            ``(aa) Whether the drugs in 
                                        a category or class are used to 
                                        treat a disease or disorder 
                                        that can cause significant 
                                        negative clinical outcomes to 
                                        individuals in a short 
                                        timeframe.
                                            ``(bb) Whether there are 
                                        special or unique benefits with 
                                        respect to the majority of 
                                        drugs in a given category or 
                                        class.
                                            ``(cc) High predicted drug 
                                        and medical costs for the 
                                        diseases or disorders treated 
                                        by the drugs in a given 
                                        category or class.
                                            ``(dd) Whether restricted 
                                        access to the drugs in the 
                                        category or class has major 
                                        clinical consequences for 
                                        individuals enrolled in a 
                                        prescription drug plan who have 
                                        a disease or disorder treated 
                                        by the drugs in such category 
                                        or class.
                                            ``(ee) The potential for 
                                        the development of 
                                        discriminatory formulary 
                                        policies based on the clinical 
                                        or functional characteristics 
                                        of such individuals and the 
                                        high cost of certain drugs in a 
                                        category or class.
                                            ``(ff) The need for access 
                                        to multiple drugs within a 
                                        category or class due to the 
                                        unique chemical action and 
                                        pharmacological effects of 
                                        drugs within the category or 
                                        class and any variation in 
                                        clinical response based on 
                                        differences in such 
                                        individuals' metabolism, age, 
                                        gender, ethnicity, 
                                        comorbidities, drug-resistance, 
                                        and severity of disease.
                                            ``(gg) Any applicable 
                                        revisions that have been made 
                                        to widely-accepted clinical 
                                        practice guidelines endorsed by 
                                        pertinent medical specialty 
                                        organizations.
                                    ``(III) Removal of categories or 
                                classes.--In updating the list in order 
                                to remove a drug in a category or class 
                                from the list of drugs required to be 
                                included on the formulary under clause 
                                (i), the Secretary may remove a drug 
                                from such list in the case where the 
                                Secretary determines that widely-
                                accepted clinical practice guidelines 
                                endorsed by pertinent national medical 
                                specialty organizations indicate that, 
                                for substantially all drugs in the 
                                category or class, restricting access 
                                to such drugs is unlikely to result in 
                                adverse clinical consequences for 
                                individuals with conditions for which 
                                the drugs are clinically indicated.''.
    (b) Limitation of Utilization Management Tools for Drugs in Certain 
Categories and Classes.--Section 1860D-4(c) of the Social Security Act 
(42 U.S.C. 1395w-104(c)) is amended--
            (1) in paragraph (1)(A), by striking ``A cost-effective'' 
        and inserting ``Subject to paragraph (3), a cost-effective''; 
        and
            (2) by adding at the end the following new paragraph:
            ``(3) Limitation of utilization management tools for drugs 
        in certain categories and classes.--
                    ``(A) In general.--A PDP sponsor of a prescription 
                drug plan may not apply a utilization management tool, 
                such as prior authorization or step therapy, to the 
                following:
                            ``(i) During the period beginning on the 
                        date of enactment of this paragraph and ending 
                        on December 31 of the year which includes the 
                        date that is 5 years after such date of 
                        enactment--
                                    ``(I) a drug in a category or class 
                                described in subsection 
                                (b)(3)(G)(i)(V); and
                                    ``(II) a drug in a category or 
                                class described in subclause (I), (II), 
                                (III), (IV), or (VI) of subsection 
                                (b)(3)(G)(i) in the case where an 
                                enrollee was engaged in a treatment 
                                regimen using such drug in the 90-day 
                                period prior to the date on which such 
                                tool would be applied to the drug with 
                                respect to the enrollee under the plan 
                                or the PDP sponsor is unable to 
                                determine if the enrollee was engaged 
                                in such a treatment regimen prior to 
                                such date.
                            ``(ii) Beginning January 1 of the year 
                        after the year which includes the date that is 
                        5 years after the date of enactment of this 
                        paragraph--
                                    ``(I) a drug in a category or class 
                                described in subsection 
                                (b)(3)(G)(i)(V), if such drug is 
                                required to be included on the 
                                formulary under subsection (b)(3)(H); 
                                and
                                    ``(II) a drug in any other category 
                                or class required to be included on the 
                                formulary under subsection (b)(3)(H) in 
                                the case where an enrollee was engaged 
                                in a treatment regimen using such drug 
                                in the 90-day period prior to the date 
                                on which such tool would be applied to 
                                the drug with respect to the enrollee 
                                under the plan or the PDP sponsor is 
                                unable to determine if the enrollee was 
                                engaged in such a treatment regimen 
                                prior to such date.
                    ``(B) Statement of evidence base for application of 
                utilization management tool.--In the case where a 
                utilization management tool is applied to a drug in a 
                category or class required to be included on a plan 
                formulary under subparagraph (G) or (H) of subsection 
                (b)(3), the PDP sponsor of such plan shall provide a 
                statement of the evidence base substantiating the 
                clinical appropriateness of the application of such 
                tool.''.
    (c) Rule of Construction.--Nothing in the provisions of this 
section, or the amendments made by this section, shall be construed as 
prohibiting the Secretary of Health and Human Services from issuing 
guidance or regulations to establish formulary or utilization 
management requirements under section 1860D-4 of the Social Security 
Act (42 U.S.C. 1395w-104) as long as they do not conflict with such 
provisions and amendments.
    (d) Effective Date.--The amendments made by this section shall 
apply to contract years beginning on or after January 1, 2008.

SEC. 3. APPEALS REQUIREMENTS FOR CERTAIN CATEGORIES AND CLASSES OF 
              DRUGS.

    (a) Coverage Determinations and Reconsideration.--Section 1860D-
4(g) of the Social Security Act (42 U.S.C. 1395w-104(g)) is amended by 
adding at the end the following new paragraph:
            ``(3) Request for a determination or reconsideration for 
        the treatment of drugs in certain categories and classes.--
                    ``(A) In general.--In the case where an individual 
                enrolled in a prescription drug plan disputes a 
                utilization management requirement, an adverse coverage 
                determination, a reconsideration by a PDP sponsor of a 
                prescription drug plan, or an adverse reconsideration 
                by an Independent Review Entity with respect to a 
                covered part D drug in the categories and classes 
                required to be included on the formulary under 
                subparagraph (G) of subsection (b)(3) or under the 
                regulations issued under subparagraph (H) of such 
                subsection, the PDP sponsor shall continue to cover 
                such prescription drug until the date that is not less 
                that 60 days after the latest of the following has 
                occurred:
                            ``(i) The enrollee has received written 
                        notice of an adverse reconsideration by a PDP 
                        sponsor.
                            ``(ii) In the case where an enrollee has 
                        requested reconsideration by an Independent 
                        Review Entity, such Entity has issued an 
                        adverse reconsideration.
                            ``(iii) In the case where an appeal of such 
                        adverse reconsideration has been filed by the 
                        individual, an administrative law judge has 
                        decided or dismissed the appeal.
                    ``(B) Definition of independent review entity.--In 
                this paragraph, the term `Independent Review Entity' 
                means the independent, outside entity the Secretary 
                contracts with under section 1852(g)(4), including such 
                an entity that the Secretary contracts with in order to 
                meet the requirements of such section under section 
                1860D-4(h)(1).''.
    (b) Appeals.--Section 1860D-4(h) of the Social Security Act (42 
U.S.C. 1395w-104(h)) is amended--
            (1) in paragraph (2), by striking ``A part D'' and 
        inserting ``Subject to paragraph (4), a part D''; and
            (2) by adding at the end the following new paragraph:
            ``(4) Treatment of appeals for drugs in certain categories 
        and classes.--
                    ``(A) In general.--A part D eligible individual who 
                is enrolled in a prescription drug plan offered by a 
                PDP sponsor may appeal under paragraph (1) a 
                determination by such sponsor not to provide coverage 
                of a covered part D drug in a category or class 
                required to be included on the formulary under 
                subparagraph (G) of subsection (b)(3) or under the 
                regulations issued under subparagraph (H) of such 
                subsection at any time after such determination by 
                requesting a reconsideration by an Independent Review 
                Entity.
                    ``(B) Definition of independent review entity.--In 
                this paragraph, the term `Independent Review Entity' 
                has the meaning given such term in subsection 
                (g)(3)(B).''.
    (c) Effective Date.--The amendments made by this section shall 
apply to contract years beginning on or after January 1, 2008.

SEC. 4. DATA REPORTING REQUIREMENTS FOR CERTAIN CATEGORIES AND CLASSES 
              OF DRUGS UNDER THE MEDICARE PART D PRESCRIPTION DRUG 
              PROGRAM.

    (a) In General.--Section 1860D-4 of the Social Security Act (42 
U.S.C. 1395w-104) is amended by adding at the end the following new 
subsection:
    ``(l) Data Reporting for Certain Categories and Classes of Drugs.--
            ``(1) In general.--A PDP sponsor offering a prescription 
        drug plan shall disclose to the Secretary (in a manner 
        specified by the Secretary) data at the plan level on the 
        number of--
                    ``(A) favorable and adverse decisions made with 
                respect to exceptions requested to formulary policies--
                            ``(i) during the period beginning on the 
                        date of enactment of this subsection and ending 
                        on December 31 of the year which includes the 
                        date that is 5 years after such date of 
                        enactment, for each of the categories and 
                        classes of drugs described in subclauses (I) 
                        through (VI) of subsection (b)(3)(G)(i); and
                            ``(ii) beginning January 1 of the year 
                        after the year which includes the date that is 
                        5 years after such date of enactment, for each 
                        of the categories and classes of drugs required 
                        to be included on the formulary under the 
                        regulations issued under subsection (b)(3)(H);
                    ``(B) favorable and adverse coverage determinations 
                made with respect to each of such categories and 
                classes during the applicable period;
                    ``(C) favorable and adverse reconsiderations made 
                by a PDP sponsor with respect to each of such 
                categories and classes during the applicable period;
                    ``(D) favorable and adverse reconsiderations made 
                by an Independent Review Entity (as defined in 
                subsection (g)(3)(B)) with respect to each of such 
                categories and classes during the applicable period; 
                and
                    ``(E) appeals made to an administrative law judge 
                and the decisions made on such appeals with respect to 
                each of such categories and classes during the 
                applicable period.
            ``(2) Annual report.--The Secretary shall--
                    ``(A) submit an annual report to Congress 
                containing the data disclosed to the Secretary under 
                paragraph (1); and
                    ``(B) publish such report in the Federal 
                Register.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply to contract years beginning on or after January 1, 2008.
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