[Congressional Record Volume 153, Number 121 (Thursday, July 26, 2007)]
[Senate]
[Pages S10156-S10159]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. Smith (for himself and Mr. Kerry):
  S. 1887. 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; to the Committee on Finance.
  Mr. Smith. Mr. President, today I am introducing the Access to 
Critical Medications Act ACMA, a bill that will vastly improve the 
coverage millions of vulnerable Medicare beneficiaries receive through 
the Medicare prescription drug program, known as Part D. The new drug 
benefit has been a tremendous success, providing access to affordable 
prescription drug therapies to millions of beneficiaries, some for the 
very first time. But many of our most vulnerable seniors, especially 
those suffering from serious health conditions like mental illness, 
HIV/AIDS or cancer, often have difficulty obtaining the vital drug 
therapies they need to remain functional, or in some cases, to survive. 
To remedy these problems, the bill I am introducing today will give the 
Centers for Medicare and Medicaid Services, CMS, the regulatory tools 
it needs to ensure that all prescription drug plans, PDP, provide 
unfettered access to medically essential drug therapies.
  My connection to this issue began long before Medicare's new 
prescription drug benefit went into effect. As chairman of the Aging 
Committee, I held a hearing in the spring of 2005 to explore how well 
CMS was preparing to transition dual-eligible beneficiaries, those who 
qualify for both Medicare and Medicaid, into Medicare Part D. At that 
hearing, advocates expressed a number of concerns with the 
implementation of the new drug benefit, and chief among them was 
guaranteeing that vulnerable beneficiaries had access to important drug 
therapies that either stabilized or improved their health condition. I 
made a personal request to then CMS Administrator Dr. Mark McClellan to 
work with prescription drug plans to ensure that their formularies 
provide access to all available drugs in certain pharmaceutical 
classes, including those that contain innovative treatments for mental 
illness, epilepsy, cancer and HIV/AIDS. The result of that conversation 
was the creation of the ``all or substantially all'' policy for six 
protected drug classes. CMS initially included this new policy as part 
of the sub-regulatory formulary guidance it issued to plans in 2005 and 
again in 2006.
  While I was pleased with CMS providing this additional protection for 
the vital drug therapies in the six protected classes, its actual 
impact on beneficiaries gaining access to the medications they need has 
been uneven at best. For one, the policy was issued as sub-regulatory 
guidance, which limits CMS' ability to enforce it. While it is true 
that the annual contracts CMS develops with prescription drug plans 
generally include a requirement that they abide by the ``all or 
substantially all'' guidance, the agency's record of enforcing the 
policy has been quite poor. Instead of plans covering all drugs in the 
six protected classes, as CMS claims plan contracts require, 
beneficiaries, often the most frail and vulnerable, have had extensive 
access problems because their PDPs do not include their medication on 
its formulary. In fact, data from a study being conducted by the 
American Psychiatric Institute for Research and Education, APIRE, 
released earlier this year, showed that roughly 68 percent of surveyed 
beneficiaries, many of them dual eligibles, experienced some sort of 
problem accessing the prescription drug they needed because their PDP's 
formulary did not cover it. This would suggest that CMS' current 
approach to enforcing the ``all or substantially all'' policy is 
woefully lacking.
  I should note that beneficiaries often are able to access a drug that 
should be covered on their plan's formulary by filing a coverage 
appeal. However, that process is usually long and difficult to 
complete, and results in the problem only being solved for one 
beneficiary. I appreciate the responsiveness of drug plans to specific 
beneficiaries' difficulties with accessing the drugs they need, but if 
they are not addressing the concerns raised through the appeals process 
on a broader scale, problems will only continue to occur. I believe we 
need a system-wide approach to ensuring that beneficiaries have access 
to the life-saving and life-improving medications they need and I 
believe that solution lies within the legislation I am filing today.
  The Access to Critical Medications Act ACMA would codify, for a 5-
year period, the current policies in CMS existing ``all or 
substantially all'' sub-regulatory guidance. I am hopeful that 
providing this statutory authority will signal to plans that it is no 
longer an option to cover all available drugs in the six protected 
classes. It is a legal requirement that must be adhered to in order to 
participate in Medicare Part D. Accordingly, I would expect that this 
change will empower CMS to take a more proactive role in ensuring that 
prescription drug plan sponsors are not placing arbitrary barriers to 
accessing these critical medications covered by the ``all or 
substantially all'' policy.
  During the 5 year period that the ``all or substantially all'' policy 
will be effective, the ACMA directs CMS to establish a process through 
regulation, that would allow for this important policy to be updated 
and enforced in future years. None of us hold the knowledge of the 
pharmaceutical and medical developments of tomorrow. In a decade, there 
could be major breakthroughs in treating any number of debilitating 
illnesses, which may require the creation of or modification of 
pharmaceutical classes covered by this important policy. CMS needs to 
have the authority to update the classes and categories it covers and 
the process the ACMA creates will provide them the tools to do that.
  In order to use those tools, the ACMA defines specific, clinically-
based criteria that the Secretary must follow when evaluating whether a 
drug class should be added or removed from coverage under the policy. 
This will ensure that there is consistency in the manner by which the 
policy is evaluated in future years, so that the Secretary is not 
arbitrarily determining which medications are important enough so that 
all plans must provide access to them. The ACMA also makes modest 
changes to the appeals process, to ensure that plans and CMS resolve 
beneficiary complaints in a timely manner, and that access to 
medications is guaranteed while the appeals process runs its course.
  The existing ``all or substantially all'' policy was a step in the 
right direction at the time it was created. However, as we approach the 
third year of Medicare's prescription drug benefit, beneficiaries' 
actual experience in the program provides overwhelming support that we 
need a more robust approach to helping vulnerable beneficiaries get the 
medications they need.

[[Page S10157]]

As importantly, CMS must have a regulatory process in place that will 
enable it to modify the classes covered by the policy in response to 
changes in medical and pharmaceutical science. I believe the ACMA 
clearly addresses both those needs, and I hope my colleagues will 
agree. It is a well thought out policy that strikes a careful balance 
between flexibility and enforceability. Advocacy groups such as the 
American Psychiatric Association, the National Alliance for Mental 
Illness, Mental Health America, the AIDS Institute, the HIV Medicine 
Association and the Epilepsy Foundation all contributed to the 
development of ACMA and all now support the finished product. The 
Senate likely will consider Medicare legislation this fall, and I have 
already mentioned to Chairman Baucus that I would like to see this bill 
advance as part of that effort.
  I ask unanimous consent that the text of therbill and letters of 
support be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                S. 1887

       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

[[Page S10158]]

     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.
                                  ____

                                    Access to Critical Medications


                                                    Coalition,

                                                    July 20, 2007.
     Hon. Gordon Smith,
     404 Russell Office Building,
     Washington, DC.
       Dear Senator Smith: We are writing on behalf of the Access 
     to Critical Medications Coalition to offer our strong support 
     for your Medicare Access to Critical Medications Act. The 
     Coalition represents a diverse group of national and 
     community-based patient, provider and advocacy organizations 
     dedicated to ensuring that Medicare beneficiaries with HIV/
     AIDS, mental illnesses, epilepsy, cancer, organ failure, and 
     autoimmune diseases have reliable access through Medicare 
     Part D to the prescriptions that they need to stay healthy.
       The Medicare Access to Critical Medications Act will 
     strengthen protections for these medically vulnerable 
     populations by codifying the requirement that Medicare Part D 
     plans cover ``all or substantially all'' drugs in the six 
     classes of drugs that are critical to treating HIV/AIDS, 
     mental illnesses, cancer, epilepsy, autoimmune diseases such 
     as Crohn's, and transplant patients. As you may know, 
     coverage of nearly all of the drugs in these categories is 
     standard practice among state Medicaid programs and private 
     insurers because it is more cost effective and better for 
     people with these conditions when clinicians have the 
     flexibility to prescribe the drug or drugs most appropriate 
     to manage the condition according to factors unique to them.
       Passage of this bill is important because the current 
     protections for these drug classes offered in Centers for 
     Medicare and Medicaid (CMS) guidance are not guaranteed 
     beyond this year and are being ignored by drug plans with no 
     risk of sanctions. Surveys of HIV and mental health medical 
     providers indicate that Medicare beneficiaries with these 
     conditions have been hospitalized or experienced dangerous 
     treatment interruptions due to challenges with Medicare Part 
     D coverage, including burdensome prior authorization 
     processes. Many of the beneficiaries reporting problems are 
     very low-income and live on Supplemental Security Income 
     (SSI) checks or modest disability payments. Paying out of 
     pocket for drugs denied by Medicare Part D drug plans is not 
     an option for most.
       On behalf of Medicare beneficiaries with these life-
     threatening illnesses, thank you for your leadership in 
     working to ensure access to critical medications through 
     Medicare Part D by requiring drug plans to cover ``all or 
     substantially all'' of the drugs available to treat these 
     serious, but treatable conditions.
                                  ____



                             American Psychiatric Association,

                                     Arlington, VA, July 24, 2007.
     Hon. Gordon Smith,
     U.S. Senate, 404 Russell Senate Office Building, Washington, 
         DC.
       Dear Senator Smith: I am writing on behalf of the American 
     Psychiatric Association (AP A), the medical specialty 
     representing more than 38,000 psychiatric physicians 
     nationwide, to express our strong support for your Medicare 
     Access to Critical Medications Act of 2007.
       This bill will provide crucial protections in the Medicare 
     Part D program for six classes of life-saving medications. 
     Part D drug plans will be required to place substantially all 
     anticancer, HIV/AIDS, and immunosuppressant medications on 
     their formularies, as well as drugs that are important to 
     people with severe mental illnesses--antipsychotics, 
     antidepressants, and anticonvulsants. In addition, when a 
     drug plan and a patient's physician disagree about whether a 
     critical medication is needed, your legislation will require 
     that the medication be covered until the appeals process can 
     be completed.
       Unfortunately, data from the first year of the Part D 
     program point to the need for additional protections for 
     patients with serious diseases. In 2006, an American 
     Psychiatric Institute for Research and Education (APIRE) 
     study tracked 1,193 dually-eligible Medicare/Medicaid 
     psychiatric patients and found that 53.4 percent experienced 
     at least one problem with medication access or continuity. 
     Among these patients, 19.8 percent had a subsequent emergency 
     room visit reported, and 11 percent had a hospitalization.

[[Page S10159]]

     Furthermore, the study found that the most common medication 
     classes with coverage problems included atypical 
     antipsychotics, antidepressants, and anticonvulsants (West, 
     Wilk, Muszynski et al, American Journal of Psychiatry, 164:5 
     May 2007).
       Clearly, Part D patients will receive better care, and the 
     Medicare program as a whole will save money, if access to 
     important medications can be improved. Your legislation will 
     create new statutory protections that will address a number 
     of the most serious barriers.
       We greatly appreciate your leadership--and the hard work of 
     your staff Matthew Canedy and Catherine Finley--in addressing 
     this serious problem.
           Sincerely,
                                      Carolyn B. Robinowitz, M.D.,
                                                        President.
                                 ______