[Congressional Record (Bound Edition), Volume 155 (2009), Part 2]
[Senate]
[Pages 1586-1591]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. DURBIN (for himself, Mr. Whitehouse, Mr. Akaka, Mr. Brown, 
        and Mr. Sanders):
  S. 330. A bill to amend title XVIII of the Social Security Act to 
deliver a meaningful benefit and lower prescription drug prices under 
the Medicare program; to the Committee on Finance.
  Mr. DURBIN. Mr. President, in the 6 years since Congress passed the 
Medicare Modernization Act, life for seniors has become increasingly 
difficult. The majority of seniors live on a fixed income, but face the 
challenge of paying more with less as the costs for everything continue 
to rise. Housing costs, basic nutrition, and healthcare needs are more 
expensive.
  The addition of a prescription drug benefit to Medicare was long 
overdue, and many senior citizens and people with disabilities are 
relieved to finally have drug coverage. But the drug benefit was not 
structured like the rest of Medicare. For all other Medicare benefits, 
seniors can choose whether to receive benefits directly through 
Medicare or through a private insurance plan. The overwhelming majority 
choose the Medicare-run option for their hospital and physician 
coverage.
  Unfortunately, no such choice is available for prescription drugs. 
Medicare beneficiaries must enroll in a private insurance plan to 
obtain drug coverage and with that are subjected to the multiple 
changes drug plans are allowed to impose on seniors year after year.
  Each drug plan has its own premium, cost-sharing requirements, list 
of covered drugs, and pharmacy network. After you have identified the 
right drug plan, you have to go through the whole process again at the 
end of the year because your plan may have changed the drugs it covers 
or added new restrictions on how to access covered drugs.
  Seniors are having trouble identifying which of the dozens of private 
drug plans works best for them. The complexity of the program has made 
beneficiaries more vulnerable to aggressive and deceptive marketing 
practices as some insurers try to steer seniors into more profitable 
Medicare Advantage plans. Some seniors have been signed up for Medicare 
Advantage plans without their knowledge, and, unfortunately, there have 
also been dishonest insurance agents who have misrepresented what 
benefits would be covered. Anyone who has visited a senior center or 
spoken with an elderly relative knows that the complexity of the drug 
benefit has created much confusion.
  Drug plans often do not tell beneficiaries that they can appeal a 
drug plan's decision to deny coverage for a drug, even though they are 
required to do so. Beneficiaries who do appeal soon find that it is a 
long and difficult process.
  Multiple studies have shown that private drug plans have not been 
effective negotiators, which means seniors end up paying more than they 
should. A report by Avalere Health released in late 2008 revealed that 
the average beneficiary will see a 24 percent increase in their monthly 
premiums for 2009. The top 10 most popular plans by enrollment will 
increase their premiums by more than 30 percent.
  Today, I am introducing the Medicare Prescription Drug Savings and 
Choice Act. The bill would create a Medicare-operated drug plan that 
would compete with private drug plans and would give the Health and 
Human Services Secretary leverage to negotiate with drug companies to 
lower drug prices.
  The Health and Human Services Secretary would have the tools to 
negotiate with drug companies, including the use of drug formulary. The 
best medical evidence would determine which drugs are covered in the 
formulary, and the formulary would be used to promote safety, 
appropriate use of drugs, and value.

[[Page 1587]]

  The bill would establish an appeals process that is efficient, 
imposes minimal administrative burdens, and ensures timely procurement 
of non-formulary drugs or non-preferred drugs when medically necessary.
  This is the kind of drug plan that Medicare beneficiaries are looking 
for. According to a survey by the Kaiser Family Foundation, two-thirds 
of seniors want the option of getting drug coverage directly from 
Medicare, and over 80 percent favor allowing the Government to 
negotiate with drug companies for lower prices.
  Seniors want the ability to choose a Medicare-administered drug plan 
and deserve a simpler, more dependable, and less costly program that 
prioritizes their needs. Let's give them this option--just as they have 
this choice with every other benefit covered by Medicare.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 330

       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 Prescription Drug 
     Savings and Choice Act of 2009''.

     SEC. 2. ESTABLISHMENT OF MEDICARE OPERATED PRESCRIPTION DRUG 
                   PLAN OPTION.

       (a) In General.--Subpart 2 of part D of the Social Security 
     Act is amended by inserting after section 1860D-11 (42 U.S.C. 
     1395w-111) the following new section:


           ``medicare operated prescription drug plan option

       ``Sec. 1860D-11A.  (a) In General.--Notwithstanding any 
     other provision of this part, for each year (beginning with 
     2010), in addition to any plans offered under section 1860D-
     11, the Secretary shall offer one or more medicare operated 
     prescription drug plans (as defined in subsection (c)) with a 
     service area that consists of the entire United States and 
     shall enter into negotiations in accordance with subsection 
     (b) with pharmaceutical manufacturers to reduce the purchase 
     cost of covered part D drugs for eligible part D individuals 
     who enroll in such a plan.
       ``(b) Negotiations.--Notwithstanding section 1860D-11(i), 
     for purposes of offering a medicare operated prescription 
     drug plan under this section, the Secretary shall negotiate 
     with pharmaceutical manufacturers with respect to the 
     purchase price of covered part D drugs in a Medicare operated 
     prescription drug plan and shall encourage the use of more 
     affordable therapeutic equivalents to the extent such 
     practices do not override medical necessity as determined by 
     the prescribing physician. To the extent practicable and 
     consistent with the previous sentence, the Secretary shall 
     implement strategies similar to those used by other Federal 
     purchasers of prescription drugs, and other strategies, 
     including the use of a formulary and formulary incentives in 
     subsection (e), to reduce the purchase cost of covered part D 
     drugs.
       ``(c) Medicare Operated Prescription Drug Plan Defined.--
     For purposes of this part, the term `medicare operated 
     prescription drug plan' means a prescription drug plan that 
     offers qualified prescription drug coverage and access to 
     negotiated prices described in section 1860D-2(a)(1)(A). Such 
     a plan may offer supplemental prescription drug coverage in 
     the same manner as other qualified prescription drug coverage 
     offered by other prescription drug plans.
       ``(d) Monthly Beneficiary Premium.--
       ``(1) Qualified prescription drug coverage.--The monthly 
     beneficiary premium for qualified prescription drug coverage 
     and access to negotiated prices described in section 1860D-
     2(a)(1)(A) to be charged under a medicare operated 
     prescription drug plan shall be uniform nationally. Such 
     premium for months in 2010 and each succeeding year shall be 
     based on the average monthly per capita actuarial cost of 
     offering the medicare operated prescription drug plan for the 
     year involved, including administrative expenses.
       ``(2) Supplemental prescription drug coverage.--Insofar as 
     a medicare operated prescription drug plan offers 
     supplemental prescription drug coverage, the Secretary may 
     adjust the amount of the premium charged under paragraph (1).
       ``(e) Use of a Formulary and Formulary Incentives.--
       ``(1) In general.--With respect to the operation of a 
     medicare operated prescription drug plan, the Secretary shall 
     establish and apply a formulary (and may include formulary 
     incentives described in paragraph (2)(C)(ii)) in accordance 
     with this subsection in order to--
       ``(A) increase patient safety;
       ``(B) increase appropriate use and reduce inappropriate use 
     of drugs; and
       ``(C) reward value.
       ``(2) Development of initial formulary.--
       ``(A) In general.--In selecting covered part D drugs for 
     inclusion in a formulary. the Secretary shall consider 
     clinical benefit and price.
       ``(B) Role of ahrq.--The Director of the Agency for 
     Healthcare Research and Quality shall be responsible for 
     assessing the clinical benefit of covered part D drugs and 
     making recommendations to the Secretary regarding which drugs 
     should be included in the formulary. In conducting such 
     assessments and making such recommendations, the Director 
     shall--
       ``(i) consider safety concerns including those identified 
     by the Federal Food and Drug Administration;
       ``(ii) use available data and evaluations, with priority 
     given to randomized controlled trials, to examine clinical 
     effectiveness, comparative effectiveness, safety, and 
     enhanced compliance with a drug regimen;
       ``(iii) use the same classes of drugs developed by United 
     States Pharmacopeia for this part;
       ``(iv) consider evaluations made by--

       ``(I) the Director under section 1013 of Medicare 
     Prescription Drug, Improvement, and Modernization Act of 
     2003;
       ``(II) other Federal entities, such as the Secretary of 
     Veterans Affairs; and
       ``(III) other private and public entities, such as the Drug 
     Effectiveness Review Project and Medicaid programs; and

       ``(v) recommend to the Secretary--

       ``(I) those drugs in a class that provide a greater 
     clinical benefit, including fewer safety concerns or less 
     risk of side-effects, than another drug in the same class 
     that should be included in the formulary;
       ``(II) those drugs in a class that provide less clinical 
     benefit, including greater safety concerns or a greater risk 
     of side-effects, than another drug in the same class that 
     should be excluded from the formulary; and
       ``(III) drugs in a class with same or similar clinical 
     benefit for which it would be appropriate for the Secretary 
     to competitively bid (or negotiate) for placement on the 
     formulary.

       ``(C) Consideration of ahrq recommendations.--
       ``(i) In general.--The Secretary, after taking into 
     consideration the recommendations under subparagraph (B)(v), 
     shall establish a formulary, and formulary incentives, to 
     encourage use of covered part D drugs that--

       ``(I) have a lower cost and provide a greater clinical 
     benefit than other drugs;
       ``(II) have a lower cost than other drugs with same or 
     similar clinical benefit; and
       ``(III) drugs that have the same cost but provide greater 
     clinical benefit than other drugs.

       ``(ii) Formulary incentives.--The formulary incentives 
     under clause (i) may be in the form of one or more of the 
     following:

       ``(I) Tiered copayments.
       ``(II) Reference pricing.
       ``(III) Prior authorization.
       ``(IV) Step therapy.
       ``(V) Medication therapy management.
       ``(VI) Generic drug substitution.

       ``(iii) Flexibility.--In applying such formulary incentives 
     the Secretary may decide not to impose any cost-sharing for a 
     covered part D drug for which--

       ``(I) the elimination of cost sharing would be expected to 
     increase compliance with a drug regimen; and
       ``(II) compliance would be expected to produce savings 
     under part A or B or both.

       ``(3) Limitations on formulary.--In any formulary 
     established under this subsection, the formulary may not be 
     changed during a year, except--
       ``(A) to add a generic version of a covered part D drug 
     that entered the market;
       ``(B) to remove such a drug for which a safety problem is 
     found; and
       ``(C) to add a drug that the Secretary identifies as a drug 
     which treats a condition for which there has not previously 
     been a treatment option or for which a clear and significant 
     benefit has been demonstrated over other covered part D 
     drugs.
       ``(4) Adding drugs to the initial formulary.--
       ``(A) Use of advisory committee.--The Secretary shall 
     establish and appoint an advisory committee (in this 
     paragraph referred to as the `advisory committee')--
       ``(i) to review petitions from drug manufacturers, health 
     care provider organizations, patient groups, and other 
     entities for inclusion of a drug in, or other changes to, 
     such formulary; and
       ``(ii) to recommend any changes to the formulary 
     established under this subsection.
       ``(B) Composition.--The advisory committee shall be 
     composed of 9 members and shall include representatives of 
     physicians, pharmacists, and consumers and others with 
     expertise in evaluating prescription drugs. The Secretary 
     shall select members based on their knowledge of 
     pharmaceuticals and the Medicare population. Members shall be 
     deemed to be special Government employees for purposes of 
     applying the conflict of interest provisions under section 
     208 of title 18, United States Code, and no waiver of such 
     provisions for such a member shall be permitted.

[[Page 1588]]

       ``(C) Consultation.--The advisory committee shall consult, 
     as necessary, with physicians who are specialists in treating 
     the disease for which a drug is being considered.
       ``(D) Request for studies.--The advisory committee may 
     request the Agency for Healthcare Research and Quality or an 
     academic or research institution to study and make a report 
     on a petition described in subparagraph (A)(ii) in order to 
     assess--
       ``(i) clinical effectiveness;
       ``(ii) comparative effectiveness;
       ``(iii) safety; and
       ``(iv) enhanced compliance with a drug regimen.
       ``(E) Recommendations.--The advisory committee shall make 
     recommendations to the Secretary regarding--
       ``(i) whether a covered part D drug is found to provide a 
     greater clinical benefit, including fewer safety concerns or 
     less risk of side-effects, than another drug in the same 
     class that is currently included in the formulary and should 
     be included in the formulary;
       ``(ii) whether a covered part D drug is found to provide 
     less clinical benefit, including greater safety concerns or a 
     greater risk of side-effects, than another drug in the same 
     class that is currently included in the formulary and should 
     not be included in the formulary; and
       ``(iii) whether a covered part D drug has the same or 
     similar clinical benefit to a drug in the same class that is 
     currently included in the formulary and whether the drug 
     should be included in the formulary.
       ``(F) Limitations on review of manufacturer petitions.--The 
     advisory committee shall not review a petition of a drug 
     manufacturer under subparagraph (A)(ii) with respect to a 
     covered part D drug unless the petition is accompanied by the 
     following:
       ``(i) Raw data from clinical trials on the safety and 
     effectiveness of the drug.
       ``(ii) Any data from clinical trials conducted using active 
     controls on the drug or drugs that are the current standard 
     of care.
       ``(iii) Any available data on comparative effectiveness of 
     the drug.
       ``(iv) Any other information the Secretary requires for the 
     advisory committee to complete its review.
       ``(G) Response to recommendations.--The Secretary shall 
     review the recommendations of the advisory committee and if 
     the Secretary accepts such recommendations the Secretary 
     shall modify the formulary established under this subsection 
     accordingly. Nothing in this section shall preclude the 
     Secretary from adding to the formulary a drug for which the 
     Director of the Agency for Healthcare Research and Quality or 
     the advisory committee has not made a recommendation.
       ``(H) Notice of changes.--The Secretary shall provide 
     timely notice to beneficiaries and health professionals about 
     changes to the formulary or formulary incentives.
       ``(f) Informing Beneficiaries.--The Secretary shall take 
     steps to inform beneficiaries about the availability of a 
     Medicare operated drug plan or plans including providing 
     information in the annual handbook distributed to all 
     beneficiaries and adding information to the official public 
     Medicare website related to prescription drug coverage 
     available through this part.
       ``(g) Application of All Other Requirements for 
     Prescription Drug Plans.--Except as specifically provided in 
     this section, any Medicare operated drug plan shall meet the 
     same requirements as apply to any other prescription drug 
     plan, including the requirements of section 1860D-4(b)(1) 
     relating to assuring pharmacy access).''.
       (b) Conforming Amendments.--
       (1) Section 1860D-3(a) of the Social Security Act (42 
     U.S.C. 1395w-103(a)) is amended by adding at the end the 
     following new paragraph:
       ``(4) Availability of the medicare operated prescription 
     drug plan.--A medicare operated prescription drug plan (as 
     defined in section 1860D-11A(c)) shall be offered nationally 
     in accordance with section 1860D-11A.''.
       (2)(A) Section 1860D-3 of the Social Security Act (42 
     U.S.C. 1395w-103) is amended by adding at the end the 
     following new subsection:
       ``(c) Provisions Only Applicable in 2006, 2007, 2008, and 
     2009.--The provisions of this section shall only apply with 
     respect to 2006, 2007, 2008, and 2009.''.
       (B) Section 1860D-11(g) of such Act (42 U.S.C. 1395w-
     111(g)) is amended by adding at the end the following new 
     paragraph:
       ``(8) No authority for fallback plans after 2009.--A 
     fallback prescription drug plan shall not be available after 
     December 31, 2009.''.
       (3) Section 1860D-13(c)(3) of such Act (42 U.S.C. 1395w-
     113(c)(3)) is amended--
       (A) in the heading, by inserting ``and medicare operated 
     prescription drug plans'' after ``Fallback plans''; and
       (B) by inserting ``or a medicare operated prescription drug 
     plan'' after ``a fallback prescription drug plan''.
       (4) Section 1860D-16(b)(1) of such Act (42 U.S.C.1395w-
     116(b)(1)) is amended--
       (A) in subparagraph (C), by striking ``and'' after the 
     semicolon at the end;
       (B) in subparagraph (D), by striking the period at the end 
     and inserting ``; and''; and
       (C) by adding at the end the following new subparagraph:
       ``(E) payments for expenses incurred with respect to the 
     operation of medicare operated prescription drug plans under 
     section 1860D-11A.''.
       (5) Section 1860D-41(a) of such Act (42 U.S.C. 1395w-
     151(a)) is amended by adding at the end the following new 
     paragraph:
       ``(19) Medicare operated prescription drug plan.--The term 
     `medicare operated prescription drug plan' has the meaning 
     given such term in section 1860D-11A(c).''.
       (c) Effective Date.--The amendments made by this section 
     shall take effect as if included in the enactment of section 
     101 of the Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003.

     SEC. 3. IMPROVED APPEALS PROCESS UNDER THE MEDICARE OPERATED 
                   PRESCRIPTION DRUG PLAN.

       Section 1860D-4(h) of the Social Security Act (42 U.S.C. 
     1305w-104(h)) is amended by adding at the end the following 
     new paragraph:
       ``(4) Appeals process for medicare operated prescription 
     drug plan.--
       ``(A) In general.--The Secretary shall develop a well-
     defined process for appeals for denials of benefits under 
     this part under the medicare operated prescription drug plan. 
     Such process shall be efficient, impose minimal 
     administrative burdens, and ensure the timely procurement of 
     non-formulary drugs or exemption from formulary incentives 
     when medically necessary. Medical necessity shall be based on 
     professional medical judgment, the medical condition of the 
     beneficiary, and other medical evidence. Such appeals process 
     shall include--
       ``(i) an initial review and determination made by the 
     Secretary; and
       ``(ii) for appeals denied during the initial review and 
     determination, the option of an external review and 
     determination by an independent entity selected by the 
     Secretary.
       ``(B) Consultation in development of process.--In 
     developing the appeals process under subparagraph (A), the 
     Secretary shall consult with consumer and patient groups, as 
     well as other key stakeholders to ensure the goals described 
     in subparagraph (A) are achieved.''.
                                 ______
                                 
      By Mrs. FEINSTEIN (for herself and Mr. Brownback):
  S. 332. A bill to establish a comprehensive interagency response to 
reduce lung cancer mortality in a timely manner; to the Committee on 
Health, Education, Labor, and Pensions.
  Mrs. FEINSTEIN. Mr. President, I rise to introduce the Lung Cancer 
Mortality Reduction Act, calling for a new effort to combat this often 
deadly form of cancer. I am pleased to be joined by Senator Brownback, 
the Co-Chair of the Senate Cancer Coalition, and a strong voice on a 
variety of cancer issues.
  This bill will renew and improve the Federal Government's efforts to 
combat lung cancer. It will affirm the goal of a 50 percent reduction 
in lung cancer mortality by 2015.
  It will authorize a Lung Cancer Mortality Reduction Program, with 
interagency coordination, to develop and implement a plan to meet this 
goal.
  It will authorize $75 million for lung cancer research programs in 
the National Heart Lung Blood Institute, National Institute of 
Biomedical Imaging and Bioengineering, National Institute of 
Environmental Health Sciences, and Centers for Disease Control.
  It will create a new incentive program in the Food and Drug 
Administration to be modeled on the Orphan Drug Act for the development 
of chemoprevention drugs for lung cancer and precancerous lung disease. 
These are drugs that could prevent precancer from progressing into 
full-blown disease.
  It will improve coordination disparity programs to ensure that the 
burdens of lung cancer on minority populations are addressed.
  We have made great strides against many types of cancer in the last 
several decades. However, these gains are uneven.
  When the National Cancer Act was passed in 1971, lung cancer had a 5-
year survival rate of only 12 percent. After decades of research 
efforts and scientific advances, this survival rate remains only 15 
percent. In contrast, the 5-year survival rates of breast, prostate, 
and colon cancer have risen to 89 percent, 99 percent and 65 percent 
respectively.
  A lung cancer diagnosis can be devastating. The average life 
expectancy following a lung cancer diagnosis is only 9 months.
  This is because far too many patients are not diagnosed with lung 
cancer

[[Page 1589]]

until it has progressed to the later stages. Lung cancer can be hard to 
diagnose, and symptoms may at first appear to be other illnesses. As a 
result, only 16 percent of lung cancer patients are diagnosed when 
their cancer is still localized, and is the most treatable.
  Lung cancer still lacks early detection technology, to find cancer 
when it is most treatable. Mammograms can find breast cancer, and 
colonoscopies can find dangerous colon polyps. But there is no 
equivalent test for lung cancer at this time.
  Under this legislation, the National Cancer Institute has clear 
authority to work with other institutes on this early detection 
research. Coordination between all branches of the National Institutes 
of Health, including those with expertise on lungs, imaging, and cancer 
will be necessary to make this long overdue progress.
  Lung cancer lags behind other cancers, in part, due to stigma from 
smoking. Make no mistake, tobacco use causes the majority of lung 
cancer cases. Tobacco cessation is a critical component of reducing 
lung cancer mortality. Less smoking means less lung cancer. Period.
  But tobacco use does not fully explain lung cancer. Approximately 15 
percent of the people who die from lung cancer never smoked. A study 
published in the Journal of Clinical Oncology in 2007 tracked the 
incidence of lung cancer in 1 million people ages 40 to 79. It found 
that about 20 percent of female lung cancer patients were nonsmokers 
and 8 percent of male patients were nonsmokers.
  These patients may have been exposed to second hand smoke, or they 
may have been exposed to radon, asbestos, chromium, or other chemicals. 
There could be other causes and associations that have not yet been 
discovered, genetic predispositions or other environmental exposures.
  Dana Reeve put a face on these statistics, with her brave fight 
against lung cancer. Dana Reeve was a nonsmoker, and still was 
diagnosed with lung cancer at the age of 44. She died a mere 7 months 
later, leaving a young son.
  Dana Reeve's story shows that smoking cannot fully explain lung 
cancer. Everyone in this country could stop smoking today, and yet we 
would still face a lung cancer epidemic. According to the Lung Cancer 
Alliance, over 60 percent of new lung cancer cases occur in those who 
never smoked, or who quit smoking.
  I believe that we have the expertise and technology to make serious 
progress against this deadly cancer, and to reach the goal of halving 
lung cancer mortality by 2015.
  We need this legislation to ensure that our Government's resources 
are focused on this mission in the most efficient way possible.
  Agency efforts must be coordinated, and every part of the National 
Institutes of Health that may have some ideas to lend should be 
participating. That is what the Lung Cancer Mortality Reduction Program 
will accomplish.
  We can do better for Americans diagnosed with lung cancer. I ask my 
colleagues to support this legislation.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 332

       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 ``Lung Cancer Mortality 
     Reduction Act of 2009''.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Lung cancer is the leading cause of cancer death for 
     both men and women, accounting for 28 percent of all cancer 
     deaths.
       (2) Lung cancer kills more people annually than breast 
     cancer, prostate cancer, colon cancer, liver cancer, 
     melanoma, and kidney cancer combined.
       (3) Since the enactment of the National Cancer Act of 1971 
     (Public Law 92-218; 85 Stat. 778), coordinated and 
     comprehensive research has raised the 5-year survival rates 
     for breast cancer to 88 percent, for prostate cancer to 99 
     percent, and for colon cancer to 64 percent.
       (4) However, the 5-year survival rate for lung cancer is 
     still only 15 percent and a similar coordinated and 
     comprehensive research effort is required to achieve 
     increases in lung cancer survivability rates.
       (5) Sixty percent of lung cancer cases are now diagnosed as 
     nonsmokers or former smokers.
       (6) Two-thirds of nonsmokers diagnosed with lung cancer are 
     women.
       (7) Certain minority populations, such as African-American 
     males, have disproportionately high rates of lung cancer 
     incidence and mortality, notwithstanding their similar 
     smoking rate.
       (8) Members of the baby boomer generation are entering 
     their sixties, the most common age at which people develop 
     lung cancer.
       (9) Tobacco addiction and exposure to other lung cancer 
     carcinogens such as Agent Orange and other herbicides and 
     battlefield emissions are serious problems among military 
     personnel and war veterans.
       (10) Significant and rapid improvements in lung cancer 
     mortality can be expected through greater use and access to 
     lung cancer screening tests for at-risk individuals.
       (11) Additional strategies are necessary to further enhance 
     the existing tests and therapies available to diagnose and 
     treat lung cancer in the future.
       (12) The August 2001 Report of the Lung Cancer Progress 
     Review Group of the National Cancer Institute stated that 
     funding for lung cancer research was ``far below the levels 
     characterized for other common malignancies and far out of 
     proportion to its massive health impact''.
       (13) The Report of the Lung Cancer Progress Review Group 
     identified as its ``highest priority'' the creation of 
     integrated, multidisciplinary, multi-institutional research 
     consortia organized around the problem of lung cancer.
       (14) The United States must enhance its response to the 
     issues raised in the Report of the Lung Cancer Progress 
     Review Group, and this can be accomplished through the 
     establishment of a coordinated effort designed to reduce the 
     lung cancer mortality rate by 50 percent by 2016 and through 
     targeted funding to support this coordinated effort.

     SEC. 3. SENSE OF THE SENATE CONCERNING INVESTMENT IN LUNG 
                   CANCER RESEARCH.

       It is the sense of the Senate that--
       (1) lung cancer mortality reduction should be made a 
     national public health priority; and
       (2) a comprehensive mortality reduction program coordinated 
     by the Secretary of Health and Human Services is justified 
     and necessary to adequately address and reduce lung cancer 
     mortality.

     SEC. 4. LUNG CANCER MORTALITY REDUCTION PROGRAM.

       (a) In General.--Subpart 1 of part C of title IV of the 
     Public Health Service Act (42 U.S.C. 285 et seq.) is amended 
     by adding at the end the following:

     ``SEC. 417G. LUNG CANCER MORTALITY REDUCTION PROGRAM.

       ``(a) In General.--Not later than 6 months after the date 
     of enactment of the Lung Cancer Mortality Reduction Act of 
     2009, the Secretary, in consultation with the Secretary of 
     Defense, the Secretary of Veterans Affairs, the Director of 
     the National Institutes of Health, the Director of the 
     Centers for Disease Control and Prevention, the Commissioner 
     of the Food and Drug Administration, the Administrator of the 
     Centers for Medicare & Medicaid Services, the Director of the 
     National Center on Minority Health and Health Disparities, 
     and other members of the Lung Cancer Advisory Board 
     established under section 6 of the Lung Cancer Mortality 
     Reduction Act of 2009, shall implement a comprehensive 
     program to achieve a 50 percent reduction in the mortality 
     rate of lung cancer by 2016.
       ``(b) Requirements.--The program implemented under 
     subsection (a) shall include at least the following:
       ``(1) With respect to the National Institutes of Health--
       ``(A) a strategic review and prioritization by the National 
     Cancer Institute of research grants to achieve the goal of 
     the program in reducing lung cancer mortality;
       ``(B) the provision of funds to enable the Airway Biology 
     and Disease Branch of the National Heart, Lung, and Blood 
     Institute to expand its research programs to include 
     predispositions to lung cancer, the interrelationship between 
     lung cancer and other pulmonary and cardiac disease, and the 
     diagnosis and treatment of these interrelationships;
       ``(C) the provision of funds to enable the National 
     Institute of Biomedical Imaging and Bioengineering to expand 
     its Quantum Grant Program and Image-Guided Interventions 
     programs to expedite the development of computer assisted 
     diagnostic, surgical, treatment, and drug testing innovations 
     to reduce lung cancer mortality; and
       ``(D) the provision of funds to enable the National 
     Institute of Environmental Health Sciences to implement 
     research programs relative to lung cancer incidence.
       ``(2) With respect to the Food and Drug Administration--
       ``(A) the establishment of a lung cancer mortality 
     reduction drug program under subchapter G of chapter V of the 
     Federal Food, Drug, and Cosmetic Act; and

[[Page 1590]]

       ``(B) compassionate access activities under section 561 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).
       ``(3) With respect to the Centers for Disease Control and 
     Prevention, the establishment of a lung cancer mortality 
     reduction program under section 1511.
       ``(4) With respect to the Agency for Healthcare Research 
     and Quality, the conduct of a biannual review of lung cancer 
     screening, diagnostic and treatment protocols, and the 
     issuance of updated guidelines.
       ``(5) The cooperation and coordination of all minority and 
     health disparity programs within the Department of Health and 
     Human Services to ensure that all aspects of the Lung Cancer 
     Mortality Reduction Program adequately address the burden of 
     lung cancer on minority and rural populations.
       ``(6) The cooperation and coordination of all tobacco 
     control and cessation programs within agencies of the 
     Department of Health and Human Services to achieve the goals 
     of the Lung Cancer Mortality Reduction Program with 
     particular emphasis on the coordination of drug and other 
     cessation treatments with early detection protocols.
       ``(c) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section--
       ``(1) $25,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(1)(B), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014;
       ``(2) $25,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(1)(C), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014;
       ``(3) $10,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(1)(D), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014; and
       ``(4) $15,000,000 for fiscal year 2010 for the activities 
     described in subsection (b)(3), and such sums as may be 
     necessary for each of fiscal years 2011 through 2014.''.
       (b) Food, Drug, and Cosmetic Act.--Chapter V of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
     amended by adding at the end the following:

        ``Subchapter G--Lung Cancer Mortality Reduction Programs

     ``SEC. 581. LUNG CANCER MORTALITY REDUCTION PROGRAM.

       ``(a) In General.--The Secretary shall implement a program 
     to provide incentives of the type provided for in subchapter 
     B of this chapter for the development of chemoprevention 
     drugs for precancerous conditions of the lung, drugs for 
     targeted therapeutic treatments and vaccines for lung cancer, 
     and new agents to curtail or prevent nicotine addiction. The 
     Secretary shall model the program implemented under this 
     section on the program provided for under subchapter B of 
     this chapter with respect to certain drugs.
       ``(b) Application of Provisions.--The Secretary shall apply 
     the provisions of subchapter B of this chapter to drugs, 
     biological products, and devices for the prevention or 
     treatment of lung cancer, including drugs, biological 
     products, and devices for chemoprevention of precancerous 
     conditions of the lungs, vaccination against the development 
     of lung cancer, and therapeutic treatment for lung cancer.
       ``(c) Board.--The Board established under section 6 of the 
     Lung Cancer Mortality Reduction Act of 2009 shall monitor the 
     program implemented under this section.''.
       (c) Access to Unapproved Therapies.--Section 561(e) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(e)) is 
     amended by inserting before the period the following: ``and 
     shall include providing compassionate access to drugs, 
     biological products, and devices under the program under 
     section 581, with substantial consideration being given to 
     whether the totality of information available to the 
     Secretary regarding the safety and effectiveness of an 
     investigational drug, as compared to the risk of morbidity 
     and death from the disease, indicates that a patient may 
     obtain more benefit than risk if treated with the drug, 
     biological product, or device.''.
       (d) CDC.--Title XV of the Public Health Service Act (42 
     U.S.C. 300k et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1511. LUNG CANCER MORTALITY REDUCTION PROGRAM.

       ``(a) In General.--The Secretary shall establish and 
     implement an early disease research and management program 
     targeted at the high incidence and mortality rates among 
     minority and low-income populations.
       ``(b) Authorization of Appropriations.--There is authorized 
     to be appropriated, such sums as may be necessary to carry 
     out this section.''.

     SEC. 5. DEPARTMENT OF DEFENSE AND THE DEPARTMENT OF VETERANS 
                   AFFAIRS.

       The Secretary of Defense and the Secretary of Veterans 
     Affairs shall coordinate with the Secretary of Health and 
     Human Services--
       (1) in the development of the Lung Cancer Mortality 
     Reduction Program under section 417E of part C of title IV of 
     the Public Health Service Act, as amended by section 4;
       (2) in the implementation within the Department of Defense 
     and the Department of Veterans Affairs of an early detection 
     and disease management research program for military 
     personnel and veterans whose smoking history and exposure to 
     carcinogens during active duty service has increased their 
     risk for lung cancer; and
       (3) in the implementation of coordinated care programs for 
     military personnel and veterans diagnosed with lung cancer.

     SEC. 6. LUNG CANCER ADVISORY BOARD.

       (a) In General.--The Secretary of Health and Human Services 
     shall establish a Lung Cancer Advisory Board (referred to in 
     this section as the ``Board'') to monitor the programs 
     established under this Act (and the amendments made by this 
     Act), and provide annual reports to Congress concerning 
     benchmarks, expenditures, lung cancer statistics, and the 
     public health impact of such programs.
       (b) Composition.--The Board shall be composed of--
       (1) the Secretary of Health and Human Services;
       (2) the Secretary of Defense;
       (3) the Secretary of Veterans Affairs; and
       (4) two representatives each from the fields of--
       (A) clinical medicine focused on lung cancer;
       (B) lung cancer research;
       (C) imaging;
       (D) drug development; and
       (E) lung cancer advocacy,
     to be appointed by the Secretary of Health and Human 
     Services.

     SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

       For the purpose of carrying out the programs under this Act 
     (and the amendments made by this Act), there is authorized to 
     be appropriated such sums as may be necessary for each of 
     fiscal years 2010 through 2014.
                                 ______
                                 
      By Mr. LUGAR:
  S. 334. A bill to authorize the extension of nondiscriminatory 
treatment (normal trade relations treatment) to the products of 
Moldova; to the Committee on Finance.
  Mr. LUGAR. Mr. President, I rise today to introduce legislation 
designed to extend permanent normal trade relations to Moldova. Moldova 
is still subject to the provisions of the Jackson-Vanik amendment to 
the Trade Act of 1974, which sanctions nations for failure to comply 
with freedom of emigration requirements. This bill would repeal 
permanently the application of Jackson-Vanik to Moldova.
  Moldova is a small country located in Europe between Ukraine and 
Romania. Throughout the Cold War it was a part of the Soviet Union. It 
gained its independence from the Soviet Union on August 27, 1991. The 
United States has supported Moldova in its journey toward democracy and 
sovereignty.
  The United States enjoys good relations with Moldova and has 
encouraged Moldovan efforts to integrate with Euro-Atlantic 
institutions. Moldova has been selected to participate in the Eastern 
Partnership, an initiative proposed by the European Union in 2008, 
which will facilitate the creation of free trade agreements, energy 
security plans, and closer economic ties between the EU and Moldova.
  Since declaring independence from the Soviet Union in 1992, Moldova 
has enacted a series of democratic and free market reforms. In 2001, 
Moldova became a member of the World Trade Organization. Furthermore, 
Moldovan President Vladimir Voronin has recently expressed his desire 
to sign an accord to strengthen relations between Moldova and the 
European Union this year. Until the United States terminates 
application of Jackson-Vanik on Moldova, the U.S. will not benefit from 
Moldova's market access commitments nor can it resort to WTO dispute 
resolution mechanisms. While all other WTO members currently enjoy 
these benefits, the U.S. does not.
  The Republic of Moldova has been evaluated every year and granted 
normal trade relations with the United States through annual 
presidential waivers from the effects of Jackson-Vanik. The Moldovan 
constitution guarantees its citizens the right to emigrate and this 
right is respected in practice. Most emigration restrictions were 
eliminated in 1991 and virtually no problems with emigration have been 
reported in the 16 years since independence. More specifically, Moldova 
does not impose emigration restrictions on members of the Jewish 
community. Synagogues function openly and without harassment. As a 
result, the administration finds that Moldova is in full compliance 
with Jackson-Vanik's provisions.
  Since declaring independence from the Soviet Union in 1992, Moldova 
has

[[Page 1591]]

enacted a series of democratic and free market reforms. Parliamentary 
elections in 2005 and local elections in 2007 generally complied with 
international standards for democratic elections.
  Moldova has also contributed constructively towards a resolution of 
the long-standing separatist conflict in the country's Transniestria 
region, most recently by proposing a series of confidence-building 
measures and working groups. In addition, trade increased between the 
two parties by 30 percent in 2007.
  The United States and Moldova have established a strong record of 
achievement in security cooperation. In 1997 the Nunn-Lugar Cooperative 
Threat Reduction Program responded to a Moldovan request for 
assistance. The U.S. purchased and secured 14 nuclear-capable MiG-29Cs 
from Moldova. These fighter aircraft were built by the former Soviet 
Union to launch nuclear weapons. Moldova expressed concern that these 
aircraft were unsecure due to the lack of funds and equipment necessary 
to ensure they were not stolen or smuggled out of the country. 
Specifically, emissaries from Iran had shown great interest and had 
attempted to acquire the aircraft. These planes were not destroyed. 
They were disassembled and shipped to Wright Patterson Air Force Base 
because they can be used by American experts for research purposes.
  Moldova has made small, but important, troop contributions in Iraq. 
These contributions include significant demining capabilities and 
contingents of combat troops. I am pleased that the United States 
remains prepared to assist in weapons and ammunition disposal and force 
relocation assistance to help deal with the costs of military 
realignments in Moldova and to assist with military downsizing and 
reforms.
  One of the areas where we can deepen U.S.-Moldovan relations is 
bilateral trade. In light of its adherence to freedom of emigration 
requirements, compliance with threat reduction and cooperation in the 
global war on terrorism, the products of Moldova should not be subject 
to the sanctions of Jackson-Vanik. The U.S. must remain committed and 
engaged in assisting Moldova in pursuing economic and development 
reforms. The government in Chisinau still has important work to do in 
these critical areas. The support and encouragement of the U.S. and the 
international community will be key to encouraging the Government of 
Moldova to take the necessary steps to initiate reform. The permanent 
waiver of Jackson-Vanik and establishment of permanent normal trade 
relations will be the foundation on which further progress in a 
burgeoning economic and energy partnership can be made.
  I am hopeful that my colleagues will join me in supporting this 
important legislation. It is essential that we act promptly to bolster 
this important relationship and promote stability in this region.

                          ____________________