Marcia L. Caronia, Linda McAuley and Arlene Feldman, Appellants,v.Philip Morris USA, Inc., Respondent.BriefN.Y.May 30, 2013CTQ-2013-00004 Court of Appeals STATE OF NEW YORK MARCIA L. CARONIA, LINDA MCAULEY, and ARLENE FELDMAN, Plaintiffs-Appellants, against PHILIP MORRIS USA, INC., Defendant-Respondent. >> >> BRIEF FOR AMICI CURIAE AMERICAN LEGACY FOUNDATION AND LUNG CANCER ALLIANCE KELNER & KELNER Attorneys for Amici Curiae American Legacy Foundation and Lung Cancer Alliance 140 Broadway, 37th Floor New York, New York 10005 212-425-0700 On Questions Certified by the United States Court of Appeals for the Second Circuit (USCOA Docket No. 11-0316-cv) To Be Submitted By: Joshua D. Kelner Date Completed: October 18, 2013 i TABLE OF CONTENTS INTEREST OF AMICI CURIAE ................................................................... 1 STATEMENT OF THE CASE ....................................................................... 5 ARGUMENT .................................................................................................. 6 POINT I THE SCIENTIFIC AND MEDICAL ACCEPTANCE OF THE EFFICACY AND CLINICAL VALUE OF LDCT IN THE EARLY DETECTION AND TREATMENT OF LUNG CANCER ESTABLISHES A KEY ELEMENT OF MEDICAL SURVEILLANCE CLAIMS, AND THAT SUCH CLAIMS ARE TIMELY ....................... 6 POINT II OVERWHELMING SCIENTIFIC EVIDENCE ESTABLISHES THAT LDCT IS AN EFFECTIVE SURVEILLANCE MECHANISM FOR THE EARLY DETECTION OF SMOKING-ATTRIBUTABLE LUNG CANCERS, WHICH IS CRITICAL TO MAKING EFFECTIVE TREATMENT POSSIBLE .................................................................... 11 A. The International Early Lung Cancer Action Program (“I-ELCAP”) Provided Clear Evidence that Lung Cancer Screening is Effective .................................................................... 13 B. The National Lung Screening Trial Substantially Validated the I-ELCAP Findings ................................................................... 15 C. National Comprehensive Cancer Network Clinical Practice Guidelines Incorporate Findings of I-ELCAP and NLST ............. 19 D. Favorable Draft Recommendations Recently Released by the United States Preventive Services Task Force Are the Final Validation of Lung Cancer Screening as Scientifically Valid and a Key Element of the Medical Standard of Care .......... 21 POINT III FAIRNESS AND EQUITY DEMAND THAT THE TOBACCO INDUSTRY BE HELD ACCOUNTABLE AND MADE TO PROVIDE HIGH QUALITY SURVEILLANCE TO REDRESS ii THE HARM IT HAS CAUSED, ESPECIALLY WITH REGARD TO THOSE VULNERABLE POPULATIONS IT CONTINUES TO TARGET .......................................................................................... 23 A. The Affordable Care Act Does Not Mandate Automatic Coverage for New Preventive Health Services By All Private Insurers of Medicare ......................................................... 26 B. Coverage of LDCT by Medicaid is Left to the Individual States .............................................................................................. 30 CONCLUSION ............................................................................................. 32 iii TABLE OF AUTHORITIES Page(s) Cases Askey v. Occidental Chemical Corp., 102 A.D.2d 130 (4th Dept. 1984) ......................................................................... 7 Ayers v. Township of Jackson, 525 A.2d 287 (N.J. 1987) ........................................................................... 7, 8, 10 Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424 (W. Va. 1999) ........................................................................ 8, 11 Burns v. Jaquays Mining Corp., 752 P.2d 28 (Ariz. Ct. App. 1987) ........................................................................ 8 Caronia v. Philip Morris USA, Inc., 715 F. 3d 417 (2d Cir. 2013) ................................................................................ 5 Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891 (Mass. 2009) ............................................................... 8, 9, 10, 11 Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Cir. 1984) ........................................................................ 7, 26 Hansen v. Mountain Fuel Supply Co., 858 P.2d 970 (Utah 1993) ..................................................................... 8, 9, 10, 11 Lamping v. American Home Products, 2000 Mont. Dist. LEXIS 2580 (Mont. Dist. Ct. 2000) ......................................... 8 Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566 (U.S. 2012) .......................................................................... 31, 32 In re Paoli R. Yard PCB Litigation, 916 F.2d 829 (3d Cir. 1990) ................................................................................. 8 Petito v. A.H. Robins Co., 750 So.2d 103 (Fla. Ct. App. 3d Dist. 1999) ........................................................ 8 Potter v. Firestone Tire & Rubber Co., 863 P.2d 795 (Cal. 1993) ................................................................................ 8, 10 iv Redland Soccer Club Inc. v. Dep’t of the Army, 696 A.2d 137 (Pa. 1997) ................................................................................. 8, 10 Statutes 42 U.S.C. 201, Oct. 9, 1998 ..................................................................................... 24 Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152) .............. 27 Patient Protection & Affordable Care Act (Pub.L.111-148) ................................... 27 Other Authorities 45 C.F.R. Part 147, July 19, 2010 ............................................................................ 28 B. Pyenson, et al., An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost . 30 Claudia I. Henschke et al., Survival of patients with stage I lung cancer detected on CT screening, 355 New. Eng. J. Med. 1763, 1763-71 (2006) ........................ 4, 16 Garth H. Rauscher, et al., Disparities in Screening Mammography Services by Race/Ethnicity and Health Insurance ................................................................. 24 K. Robin Yabroff, et al., Cost of Care for Elderly Cancer Patients in the United States ................................................................................................................... 30 Kaiser Family Foundation and Health Research and Educational Trust, Employer Health Benefits-2013 Annual Survey .................................................................. 29 Kristine Fiore, Mortality Benefit Seen With CT Halts Lung Cancer Screening Trial4, 18 M. Foy, et al., Modeling the Mortality Reduction Due to CT Screening for Lung Cancer ................................................................................................................. 19 National Comprehensive Cancer Network, Lung Cancer Prevention .................... 21 National Comprehensive Cancer Network, Screening Guidelines for Physicians…21 National Lung Trial Screening Team, Reduced Lung-Cancer Mortality with Low- Dose Computed Tomographic Screening. 365 New Eng. J. Med., 395-409 (2011) ............................................................................................................ 17, 19 v R. Doll, et al., Mortality in relation to smoking: 50 years’ observation on male British doctors ..................................................................................................... 25 Report by the Kaiser Family Foundation, Status of State Action on Medicaid Expansion Decisions, as of September 30, 2013 ................................................ 32 S. Goldberg, et al., An actuarial approach to comparing early stage and late stage lung cancermortality and survival ...................................................................... 20 1 American Legacy Foundation and Lung Cancer Alliance respectfully submit this brief, accompanied by their motion for amicus curiae relief under 22 N.Y.C.R.R. §§ 500.12(e) and 500.23, in support of Plaintiff-Appellants Marcia Caronia, Linda McAuley, and Arlene Feldman, in the above-captioned action. INTEREST OF AMICI CURIAE Amici American Legacy Foundation and Lung Cancer Alliance are nonprofit public health organizations that for decades have worked to educate the public about and protect it from the devastating health consequences of tobacco use, including lung cancer. In particular, Amici have broad expertise with regard to the development and efficacy of Low-Dose Computed Tomography (“LDCT”) for the early detection of lung cancer. Lung cancer is the leading cause of cancer death in the United States.1 It accounts for 28% of cancer deaths in men and 26% in women.2 It is the leading cancer killer in all racial and ethnic subgroups.3 Veterans are at greater risk for 1 Nadia Howlader et al., Surveillance Epidemiology & End Results (SEER) Cancer Statistics Review, 1975-2010, National Cancer Institute, available at http://seer.cancer.gov/csr/1975_2010/ (last visited October 3, 2013) (hereinafter “SEER Cancer Statistics Review”). 2 Ibid. 3 Ibid. 2 lung cancer.4 An estimated 228,190 Americans will be diagnosed with lung cancer (including the bronchus) and 159,480 will die of it in 2013.5 To put the number of deaths in perspective, lung cancer takes as many lives as breast, prostate, colorectal and pancreatic cancers combined.6 Smoking causes the great majority of lung cancers. In the United States, about 90% of lung cancer deaths in men and nearly 80% of lung cancer deaths in women are due to smoking.7 Often described as a stealth cancer, lung cancer is rarely detected until late stage, when treatment options are limited and in most cases, futile.8 They are also twice as costly as early stage treatment.9 Until relatively recently, reliable early detection mechanisms for lung cancer were not available. This is no longer the case. Scientific evidence that has been 4 Shelton Crawford III, et al., A Study of Cancer in the Military Beneficiary Population, 172 Military Medicine 1084-88 (Oct. 2007). 5 See SEER Cancer Statistics Review, supra n.1 6 Ibid. 7 U.S. Department of Health and Human Services, Center for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, The Health Consequences of Smoking: A Report of the Surgeon General, Atlanta, GA (2004), available at www.surgeongeneral.gov/library/reports/smokingconsequences/index.html (last visited Oct. 4, 2013). 8 See Lung Cancer Stage of Diagnosis and Survival Chart, available at http://seer.cancer.gov/statfacts/html/lungb.html (last visited October 2, 2013). 9 B.S. Pyenson, et al., An actuarial analysis shows that offering lung cancer screening as an insurance benefit would save lives at relatively low cost, 31 Health Aff. 4 (2012) Appx. at p. 13. 3 mounting for over two decades has become so compelling that there is now broad consensus in the scientific and medical communities that LDCT is an effective tool for the early detection of lung cancer for persons at high risk. In 1992, the first serious study evaluating whether LDCT is an effective screening tool for lung cancer began with the “Early Lung Cancer Program” in New York. It sought to determine the difference between chest X-ray and LDCT in the early detection of lung cancer.10 The program expanded to multiple sites across New York and then internationally, eventually becoming known as the International Early Lung Cancer Action Program (“I-ELCAP”). I-ELCAP results – published in October 2006 in the New England Journal of Medicine – showed that LDCT could detect lung cancer at its earliest stage, and that when followed by prompt surgical removal of the tumor, the 10-year survival rate for lung cancer reached 92%.11 The I-ELCAP findings were substantially validated by the National Cancer Institute (“NCI”). In November 2010, the NCI’s National Lung Screening Trial (“NLST”) was halted12 after it showed that participants who received a LDCT had 10 See www.ielcap.org/ielcap (last visited October 3, 2013). 11 Claudia I. Henschke et al., Survival of patients with stage I lung cancer detected on CT screening, 355 New. Eng. J. Med. 1763, 1763-71 (2006). 12 See “Statement Concerning the National Lung Screen Trial,” Oct. 28, 2010, available at www.cancer.gov/images/DSMB-NLST (last visited Oct. 3, 2013); see also Kristine Fiore, Mortality Benefit Seen With CT Halts Lung Cancer Screening 4 a 20 percent lower risk of dying from lung cancer than participants who received standard chest X-rays.13 Most recently, in July 2013, the United States Preventive Services Task Force (“USPSTF”)14 issued draft recommendations that call for annual LDCT for lung cancer in high-risk populations.15 Amici submit this brief to bring to the Court’s attention relevant and timely information regarding the scientific validity of LDCT in the early identification of lung cancers among heavy current and former smokers, and its emergence as the medical standard of care for this high-risk group. This information pertains directly to the questions certified to this Court by the United States Court of Appeals for the Second Circuit in Caronia v. Philip Morris USA, Inc., 715 F. 3d 417, 450 (2d Cir. 2013): whether New York law recognizes a cause of action for medical Trial. MedPage Today, Nov. 4, 2010, available at http://www.medpagetoday.com/HematologyOncology/LungCancer/23158 (last visited Oct. 3, 2013). 13 See http://www.cancer.gov/clinicaltrials/noteworthy-trials/nlst (last visited Oct. 3, 2013). 14 Established in 1984 and administered by the Department of Health and Human Services (HHS) Agency for Healthcare Research Quality (ARHQ) since 1998, the US Preventive Services Task Force is an independent volunteer panel of physicians from the fields of preventive and primary care medicine – including internal medicine, family practice, pediatrics, behavioral health, obstetrics & gynecology and nursing who make recommendations for preventive care based on a rigorous review of existing peer reviewed evidence. USPSTF recommendations apply only to people who have no signs or symptoms of a specific disease. See www.uspreventiveservicesstaskforce.org/abt.htm (last visited Oct. 3, 2013). 15 http://www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcandraftrec.ht m (last visited Oct. 3, 2013). 5 monitoring by heavy smokers not yet diagnosed with a smoking-related disease or under investigation by a physician for such disease, when such a claim accrues, and what the elements of such a claim are. STATEMENT OF THE CASE Amici incorporate by reference the Statement of Plaintiffs-Appellants. 6 ARGUMENT POINT I THE SCIENTIFIC AND MEDICAL ACCEPTANCE OF THE EFFICACY AND CLINICAL VALUE OF LDCT IN THE EARLY DETECTION AND TREATMENT OF LUNG CANCER ESTABLISHES A KEY ELEMENT OF MEDICAL SURVEILLANCE CLAIMS, AND THAT SUCH CLAIMS ARE TIMELY. “It is difficult to dispute that an individual has an interest in avoiding expensive diagnostic examinations just as he or she has an interest in avoiding physical injury.” Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816, 826 (D.C. Cir. 1984). “When a defendant negligently invades this interest, … it is elementary that the defendant should make the plaintiff whole by paying for the examinations.” Id.; see also Ayers v. Township of Jackson, 525 A.2d 287, 312 (N.J. 1987)(“It is inequitable for an individual, wrongfully exposed to dangerous toxic chemicals but unable to prove that disease is likely, to have to pay his own expenses when medical intervention is clearly reasonable and necessary.”); Askey v. Occidental Chemical Corp., 102 A.D.2d 130, 137 (4th Dept. 1984)(“[A]s a matter of public policy the tort-feasor should bear [the] cost” of medical monitoring.). Since the Askey decision nearly three decades ago, medical surveillance has gained broad recognition in courts across the country. Jurists have praised monitoring claims as promoting critical policy objectives, including deterrence of 7 misconduct, reduction of morbidity and mortality, and compelling the wrongdoer to shoulder the costs its malfeasance occasions. See, e.g., Burns v. Jaquays Mining Corp., 752 P.2d 28, 33 (Ariz. Ct. App. 1987); Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 1007 (Cal. 1993); Petito v. A.H. Robins Co., 750 So.2d 103, 106-107 (Fla. Ct. App. 3d Dist. 1999); Donovan v. Philip Morris USA, Inc., 914 N.E.2d 891, 894-895 (Mass. 2009); Lamping v. American Home Products, 2000 Mont. Dist. LEXIS 2580, *14 (Mont. Dist. Ct. 2000); Ayers, 525 A.2d at 312; Redland Soccer Club Inc. v. Dep’t of the Army, 696 A.2d 137, 195-196 (Pa. 1997); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993). Courts have likewise recognized that for there to be a medical monitoring claim, there must be efficacious surveillance available, capable of detecting the subject disease. Medical monitoring claims would be illogical if there were no surveillance a physician could offer consistent with standards of care. See Bower v. Westinghouse Elec. Corp., 522 S.E.2d 424, 433 (W. Va. 1999)(“If no such test exists, then periodic monitoring is of no assistance and the cost of such monitoring is not available”)(citation omitted). Accordingly, courts have routinely included as an element of surveillance claim the existence of an effective medical test for reliable early detection. See, e.g., In re Paoli R. Yard PCB Litigation, 916 F.2d 829, 852 (3d Cir. 1990) (including, as an element of medical monitoring claim, that “[m]onitoring and 8 testing procedures exist which make the early detection and treatment of the disease possible and beneficial”). These elements were recently and appropriately incorporated by the Supreme Judicial Court of Massachusetts, in a class action brought by Marlboro smokers in that Commonwealth aged fifty or older, with a twenty pack-year history. Donovan, supra. Addressing the very issues presented here, the Supreme Judicial Court permitted medical monitoring claims, identifying the following elements of a surveillance cause of action: (1) The defendant’s negligence (2) caused (3) the plaintiff to become exposed to a hazardous substance that produced, at least, subcellular changes that substantially increased the risk of serious disease, illness, or injury (4) for which an effective medical test for reliable early detection exists, (5) and early detection, combined with prompt and effective treatment, will significantly decrease the risk of death or the severity of the disease, illness or injury, and (6) such diagnostic medical examinations are reasonably (and periodically) necessary, conformably with the standard of care, and (7) the present value of the reasonable cost of such tests and care, as of the date of the filing of the complaint. Donovan at 902 (emphasis added). The Supreme Court of Utah similarly required the plaintiff to establish that “a medical test for early detection exists . . . for which early detection is beneficial, meaning that a treatment exists that can alter the course of the illness.” Hansen, 858 P.2d at 979. As that Court explained, “[i]f no such test exists, then periodic monitoring is pointless and no cause of action for monitoring exists.” Id. at 979; 9 see also id., n.12. In a leading case, the Supreme Court of New Jersey likewise held that the proof must demonstrate, inter alia, “the value of early diagnosis, that such surveillance to monitor the effect of exposure to toxic chemicals is reasonable and necessary.” Ayers, 525 A.2d at 312; see also, e.g., Potter, 863 P.2d at 823 (“the clinical value of early detection and diagnosis” are relevant to determination of the reasonableness and necessity of monitoring); Redland Soccer Club, Inc., 696 A.2d at 146 (requiring showing of “a monitoring procedure that makes early detection possible[,]” which is “reasonably necessary according to contemporary scientific principles.”16 For the same reasons, courts have held that the availability of an effective early screening mechanism and its inclusion in the applicable standard of care are directly relevant to the timeliness of an action for medical monitoring. Thus, the Donovan court held that a medical surveillance claim does not accrue until “(1) there is a physiological change resulting in a substantial increase in the risk of cancer, and (2) that increase, under the standard of care, triggers the need for 16 The Pennsylvania Supreme Court expressly rejected the notion that a plaintiff must show that a treatment currently exists for the disease, expressing concern that “[t]o do so would unfairly prevent a plaintiff from taking advantage of advances in medical science.” Redland Soccer Club 696 A.2d at 146, n.8. In any event, in this case, effective treatments for lung cancer do exist, but only if it is caught at an early stage, making the need for medical monitoring that much more important. 10 available diagnostic testing that has been accepted in the medical community as an efficacious method of lung cancer screening or surveillance.” 914 N.E.2d at 903 (emphasis added); see also Hansen, 858 P.2d at 979, n.12 (“Of course, if a test is later developed that will detect the disease, a plaintiff would retain the right to demonstrate at some later date the effectiveness of the test and be compensated for utilizing it, if all other elements of the cause of action are present.”); Bower, 522 S.E.2d at 433 (same). As Amici explain below, the evidence demonstrating the efficacy of LDCT – now widely accepted by the scientific and medical communities and incorporated into the standard of care – persuasively and thoroughly satisfies key requirements of a cause of action for medical monitoring. It also establishes that this case is timely. First, it is now beyond reasonable dispute that LDCT is an effective and scientifically reliable test for the early detection of lung cancer. LDCT identifies cancers that would not otherwise be apparent, not only to lay persons but also to physicians. This is a critical and life-saving development, which no earlier technology was able to achieve. Second, LDCT is highly beneficial because, when combined with prompt surgical intervention, it will significantly decrease the risk of lung cancer mortality. Third, given the stealth nature of lung cancer and its undeniable link to smoking, LDCT is also reasonably and periodically necessary 11 when administered to a high-risk population of current or former heavy smokers. Finally, while LDCT is not recommended for the general population, providing it to heavy smokers at increased risk of developing lung cancer conforms with applicable standards of care that emerged in the peer-reviewed literature in 2006. Those standards have since been validated, first, by the National Cancer Institute, and most recently by favorable recommendations on lung cancer screening released by the U.S. Preventive Services Task Force. POINT II OVERWHELMING SCIENTIFIC EVIDENCE ESTABLISHES THAT LDCT IS AN EFFECTIVE SURVEILLANCE MECHANISM FOR THE EARLY DETECTION OF SMOKING-ATTRIBUTABLE LUNG CANCERS, WHICH IS CRITICAL TO MAKING EFFECTIVE TREATMENT POSSIBLE. Computerized Tomography (“CT”) first became commercially utilized in medicine in the 1970s. Unlike the single, two-dimensional images provided through traditional X-rays, CT technology takes a series of cross-cut images of the chest and lungs in slices less than millimeter each, which are then reconstructed by computer into highly detailed three-dimensional images. The superiority of the three-dimensional images derived from CT scans over single image two- dimensional X-rays led to the rapid incorporation of CTs into diagnostic and preventive protocols and its adoption as a standard of care for a wide variety of 12 diseases and conditions. Advances in imaging technology have been rapid, and are ongoing. Today, LDCT scans allow for detection of lung cancer tumors when they are very small and generally still localized.17 The effectiveness of LDCT for the early detection of lung cancer has been conclusively determined through major clinical trials conducted by university researchers and the National Cancer Institute. The significance of these findings cannot be overstated. Detecting lung cancer early is the key to surviving a lung cancer diagnosis. Data from The Surveillance, Epidemiology, and End Results (“SEER”) Program of the National Cancer Institute show that when lung cancer is diagnosed when it is still in a localized stage and confined to its primary site, there is a 53.5% survival rate. Only 15% of lung cancers are found at this localized stage. Sadly, most lung cancers (57%) are found after they have metastasized. At this stage, survival rates drop to a mere 3.9%.18 There is no cure for advance stage lung cancer. Even highly touted targeted therapies work primarily to extend lives, not to save them.19 The only known reliable cure for lung cancer today is surgical removal. It is only a viable option 17 See www.cancer.gov/newscenter/qa/2002/nlstqaQA (CT scan “can detect tumors well under 1 centimeter (cm), or .4 inches in size….”) (last visited Oct. 3, 2013). 18 See http://seer.cancer.gov/statfacts/html/lungb.html (last visited Oct. 3, 2013). 19 See C.M. Rocha-Lima & L.E. Raez, Erlotinib (Tarceva) for Treatment of Non- Small-Cell Lung Cancer & Pancreatic Cancer, 34 Pharmacy & Therapeutics 554- 564 (2009) (finding that median duration of response is 7.9 months). 13 when the cancer is found early stage.20 A. The International Early Lung Cancer Action Program (“I-ELCAP”) Provided Clear Evidence that Lung Cancer Screening Is Effective The path to scientifically validating LDCT screening as the medical standard of care for the early detection and treatment of lung cancer began in 1992, when a group of physicians from Cornell University Medical Center (now Weill Medical College of Cornell University) began to investigate the potential of CT scans to detect lung cancer early.21 After publishing a research regimen in 1994,22 the Cornell Medical College team partnered with specialists at New York University to carry out a study on the efficacy of CT screening in detecting lung cancer at early stage. Together, they screened 1,000 asymptomatic high-risk individuals. The findings from this ELCAP study were published in The Lancet on July 10, 1999. They indicated that under the well-defined screening regimen ELCAP had developed, 80% of lung cancers could be diagnosed at Stage 1. At that point, the percentage of lung cancers detected at early stage had never gone above 15.23 Although the publication of this preliminary article in 1999 did not result in 20 See http://www.mayoclinic.com/health/lung- cancer/DS00038/DSECTION=treatments-and-drugs (last visited Oct. 3, 2013). 21 See www.ielcap.org/ielcap (last visited Oct. 3, 2013) 22 Claudia I. Henschke, et al., Radiographic screening for cancer. Proposed paradigm for requisite research, 18 Clin. Imaging 16-20 (1994). 23 Claudia I. Henschke, et al., Early Lung Cancer Action Project: overall design and findings from baseline screening, 354 The Lancet 9173, 99-105 (1999). 14 immediate utilization of LDCT surveillance outside the context of clinical trials, members of the national medical community heralded this finding as groundbreaking, and a cause for further research. For example, Dr. John D. Minna, a lung cancer specialist and then the director of the Harmon Center for Therapeutic Oncology Research at the University of Texas Southwestern Medical Center in Dallas stated: This is a very important study that has major clinical implications in the near future. . . . It dramatically shows the time has come to reopen lung cancer screening trials in current and former smokers using the new CAT (sic) technology.24 After the publication of the ELCAP study in The Lancet, interest in ELCAP grew. A consortium of twelve New York based institutions – including Cornell Medical College and NYU – came together as NY-ELCAP and were able to duplicate on a larger scale the 1999 results.25 ELCAP also expanded internationally and operates today in 69 sites in 22 states and 8 foreign countries.26 In October 2006, twelve years of research and observational studies by I- ELCAP were published in the prestigious, peer-reviewed New England Journal of 24 Denise Grady, Cat Scan Process Could Cut Deaths From Lung Cancer, N.Y. Times, July 9, 1999, available at http://www.nytimes.com/1999/07/09/us/cat-scan- process-could-cut-deaths-from-lung-cancer.html (last visited Oct. 3, 2013). 25 NY-ELCAP Investigators, CT Screening for lung cancer: diagnoses resulting from the New York Early Lung Cancer Action Project, 243 Radiology 239-49 (2007). 26 http://www.ielcap.org (last visited Oct. 3, 2013). 15 Medicine.27 At that time, 31,357 high-risk individuals had been screened for lung cancer. The participants were 40 years of age and older and at risk for lung cancer because of a history of cigarette smoking, occupational exposure (to asbestos, beryllium, uranium, or radon), or exposure to secondhand smoke. The published results of the I-ELCAP study were compelling. They showed that lung cancer can be detected at its very earliest stage in 85 percent of patients using annual LDCT screening, and that when followed by prompt surgical removal, the 10-year survival rate is 92 percent.28 The I-ELCAP study was the first major trial to prove that LDCT screening can transform lung cancer from a cancer that is almost always lethal to a treatable and survivable one. B. The National Lung Screening Trial Substantially Validated the I- ELCAP Findings. By the time that the I-ELCAP results were published in 2006, the National Cancer Institute had embarked an expansive randomized controlled trial of its own to assess the value and validity of low dose CT screening for the early detection of lung cancer. The NLST began in 2002 specifically to determine the efficacy of LDCT as a means to reduce mortality from lung cancer, using chest X-rays in a 27 Claudia I. Henschke, Survival of patients with stage I lung cancer detected on CT screening, 355 New Eng. J. Med. 1763-71(2006) 28 Ibid. 16 control group.29 Over 53,000 people at high risk for lung cancer but with no symptoms of the disease were recruited.30 For purposes of the study, the NLST trial designated a person at high risk for lung cancer if he or she was a current or former smoker between 55 and 74 years of age with a 30 “pack year” history – which translates into the number of packs of cigarettes smoked each day multiplied by number of years smoked. Former smokers meeting the age and smoking history criteria could participate in the trial only if they had quit within the past 15 years.31 Half of the NLST participants were randomly assigned to an arm that would receive a chest X-ray each year for three years. The other half were assigned to an arm that would receive a LDCT scan each year for three years.32 NCI explained that it studied the specific high-risk population involved in the trial, and also made the decision to screen trial participants only three times, for reasons of cost and efficiency.33 29 The National Lung Trial Screening Team, Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. 365 New Eng. J. Med., 395-409 (2011), available at http://www.nejm.org/doi/full/10.1056/NEJMoa1102873#t=articleTop (last visited Oct. 4, 2013) 30 Ibid. 31 Ibid. 32 Ibid. 33 See NLST Questions & Answers, “Implications of the NLST Findings,” Question 8, paragraph 2, available at http://www.cancer.gov/newscenter/qa/2002/nlstqaQA (last visited Oct. 4, 2013) 17 By 2010, early results from the NLST showed that there were 20% fewer lung cancer deaths in trial participants who had received LDCT compared to those who had received annual chest X-rays.34 As a result of this early finding, NCI’s Independent Data and Safety Monitoring Board (“DSMB”)35 determined that the benefits shown by the trial were significant enough that the trial should be halted. The DSMB issued a formal statement on October 28, 2010.36 There is a clear sense of urgency in this DSMB statement where it advises NCI to release the new information “without delay, recognizing the potential importance of the information. . . .”37 On November 4, 2010, letters were sent to trial participants stating “we now know that screening for lung cancer with low-dose helical (spiral) CT can reduce 34 See www.cancer.gov/clinicaltrials/noteworthy-trials/nlst (last visited Oct. 3, 2013). 35 Data and Safety Monitoring Boards are impartial groups that oversee clinical trials and reviews results to see if they are acceptable. DSMBs are in place at NIH and NCI to “insure the safety of participants, the validity of data, and the appropriate termination of studies for which significant benefits or risks have been uncovered. . . .” See www.cancer.gov/clinicaltrials/conducting/dsm-guidelines (last visited Oct. 3, 2013). 36 Statement Concerning the National Lung Screen Trial, Oct. 28, 2010, available at www.cancer.gov/images/DSMB-NLST (visited Oct. 3, 2013)(emphasis added); see also Kristine Fiore, Mortality Benefit Seen With CT Halts Lung Cancer Screening Trial, MedPage Today, Nov. 4, 2010, http://www.medpagetoday.com/HematologyOncology/LungCancer/23158 (last visited Oct. 3, 2013). 37 Ibid. 18 deaths from lung cancer by 20% in individuals aged 55 to 74 who are former or current heavy smokers.” The letter went on to say “[B]ecause the results of the NLST show that screening will save lives, we were obliged to make the results public as quickly as possible.”38 On the same day when the letter was sent to trial participants, the NCI issued a press release announcing preliminary NLST trial findings.39 The NLST findings were subsequently published in the New England Journal of Medicine in June 2011.40 The NLST irrefutably showed that a LDCT screen each year for three years could reduce mortality rates by 20% more than chest X-rays.41 Other studies have shown that annual LDCT over a longer period yields an even higher mortality benefit.42 Notably, a trial operating on a parallel track to the NLST definitively 38 See Letter to NLST Trial Participants, Nov. 4, 2010 (emphasis added), available at http://www.cancer.gov/PublishedContent/Files/images/ParticipantNLST.pdf (last visited Oct. 6, 2013). 39 http://www.cancer.gov/newscenter/newsfromnci/2010/NLSTresultsRelease (last visited Oct. 3, 2013). 40 The National Lung Trial Screening Team, Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening, supra p. 395 n.29. 41 By comparison, randomized controlled trials indicate that annual mammograms for all women ages 40 through 74 can reduce breast cancer mortality by an average of 15% to 20%. See http://www.cancer.gov/cancertopics/pdq/screening/breast/healthprofessional/page1 (last visited Oct. 3, 2013). 42 See M. Foy, et al., Modeling the Mortality Reduction Due to CT Screening for Lung Cancer, 117 Cancer 12, 2703-08 (2011) (concluding that modeling shows up to a 45.6% percent mortality benefit for LDCT screening); see also Claudia I. 19 reaffirmed that X-rays offer no mortality benefit in screening for lung cancer.43 Later in 2011, an analysis by Milliman Inc., a leading international actuarial firm, was published in Population Health Management. That analysis cross- referenced over 300,000 lung cancer records in the National Cancer Institute’s SEER database against national death data. It determined that shifting lung cancer diagnosis to early stage could save 70,000 lives a year.44 C. National Comprehensive Cancer Network Clinical Practice Guidelines Incorporate Findings of I-ELCAP and NLST. As early as 2008, the National Comprehensive Cancer Network (“NCCN”), a not-for-profit alliance of twenty-three of the world’s leading cancer centers,45 issued new guidelines on lung cancer screening. Although it did not recommend widespread screening in 2008, these guidelines advised people at high risk for lung cancer to participate in a clinical trial for LDCT screening, or to go a center with expertise in all areas of lung cancer diagnosis and treatment to discuss the potential risks and benefits of LDCT. They also specifically advised that “if a screening Henschke, et al., Assessment of lung-cancer mortality reduction from CT Screening, 71 Lung Cancer 3, 328-32 (2011). 43 Prostate, Lung, Colon and Ovarian Cancer Screening Trial, 2012, No mortality benefit use of X-ray to screen for lung cancer, even in smokers, available at http://www.cancer.gov/newscenter/featurednews/2012/PLCOtrialBackgrounder (last visited Oct. 3, 2013). 44 S. Goldberg, et al., An actuarial approach to comparing early stage and late stage lung cancermortality and survival. 13 Popul. Health Manag. 1, 33–46 (2010). 45 See http://www.nccn.org/about/default.aspx (last visited Oct. 3, 2013). 20 strategy is used, then the I-ELCAP screening protocol should be followed.”46 Then, in November 2011, NCCN formally endorsed LDCT screening for those at high risk for lung cancer and published guidelines for its membership.47 Significantly, the NCCN guidelines went beyond the NLST population to include recommendations for screening people who had additional risk factors. Thus, NCCN identified as high risk current and former smokers as young as 50, who had a twenty “pack year” history of smoking and who also had an additional risk factor for lung cancer such as workplace exposure to carcinogens or family history of lung cancer. Expanding its guidelines and recommendations in this way was consistent with expectations from NCI with regard to the NLST findings. As the NCI itself points out, “[a]s with all cancer clinical trials, the NLST provided answers to a set of very specific questions related to a defined population.”48 NCI goes on to explain that “clinical guidelines will continue to be developed over time that 46 National Comprehensive Cancer Network, Lung Cancer Prevention and Screening, Practice Guidelines in Oncology, v.2 (2008). 47 See National Comprehensive Cancer Network, Screening Guidelines for Physicians, available at http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#detection, (last visited Oct. 3, 2013); see also National Comprehensive Cancer Network, Guidelines for Patients, available at http://www.nccn.org/patients/guidelines/lung_screening/index.html#/12/ (last visited Oct. 3, 2013). 48 “Implications of NLST Findings,” available at http://www.cancer.gov/newscenter/qa/2002/nlstqaQA (last visited Oct. 3, 2013). 21 consider the totality of findings from the NLST.”49 Both sets of NCCN guidelines serve as crucial validation points for 2006 I- ELCAP findings and validated the use of LDCT as a standard of medical care. D. Favorable Draft Recommendations Recently Released by the United States Preventive Services Task Force Are the Final Validation of Lung Cancer Screening as Scientifically Valid and A Key Element of the Medical Standard of Care. To the extent any doubts remained regarding the scientific validity of LDCT screening in the early detection of lung cancer, they have been put to rest by the July 29, 2013 Draft Recommendations of the United States Preventive Services Task Force (“USPSTF”). It gave LDCT screening for lung cancer a “B” recommendation.50 USPSTF is an independent panel of preventive health experts first convened in 1984 by the United States Public Health Service and currently administered by AHRQ within HHS.51 A “B” grade means that USPSTF recommends coverage.52 While Amici are optimistic that the draft USPSTF 49 Id. 50 See www.uspreventiveservicestaskforce.org/uspstf13/lungcan/lungcandraftrec.htm (last visited Oct. 3, 2013). 51 See www.uspreventiveservicestaskforce.org/about.htm (last visited Oct. 3, 2013). 52 “B” recommendations mean that the USPSTF has found that “there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” See www.uspreventiveservicestaskforce.org/uspstf/grades.htm (last visited Oct. 3, 22 recommendations will be adopted and lead to broad coverage, such coverage will not be automatic for most Americans, nor will it be free, as discussed below. The most important aspect of the USPSTF recommendation is that it has put to rest any lingering questions regarding LDCT’s life-saving benefits. While there had been robust debate in medical and public health circles regarding LDCT, that debate has now concluded. Medical and public health leaders across the country have now publicly endorsed LDCT. This includes the American Cancer Society,53 the American Lung Association,54 the American College of Chest Physicians,55 the Society of Thoracic Surgeons,56 the National Medical Association, the National Hispanic Medical Association, the National Conference of Asian and Pacific Islander Physicians and the Indian Health Board. 57 2013). Mammography for the early detection of breast cancer also received a “B” grade. Id. 53 See http://www.cancer.org/cancer/news/expertvoices/post/2013/01/11/weighing- the-benefits-and-risks-of-lung-cancer-screening.aspx (last visited Oct. 3, 2013). 54 See http://www.lung.org/lung-disease/lung-cancer/lung-cancer-screening- guidelines/lung-cancer-one-pager.pdf (last visited Oct. 3, 2013). 55 See http://www.chestnet.org/News/Press-Releases/2013/05/New-Lung-Cancer- Guidelines-Recommends-Establishment-of-Screening-Programs (last visited Oct. 3, 2013). 56 See http://www.sts.org/news/president-column-summer-2013 (last visited Oct. 3, 2013). 57 See http://www.lungcanceralliance.org/news/legislative-activities/2013/lca-and- others-support-high-grade-for-screening.html (last visited Oct. 3, 2013). 23 POINT III FAIRNESS AND EQUITY DEMAND THAT THE TOBACCO INDUSTRY BE HELD ACCOUNTABLE AND MADE TO PROVIDE HIGH QUALITY SURVEILLANCE TO REDRESS THE HARM IT HAS CAUSED, ESPECIALLY WITH REGARD TO THOSE VULNERABLE POPULATIONS IT CONTINUES TO TARGET. Amici are profoundly concerned about both equitable access to LDCT, and the quality of LDCT that is provided. Past history with other widely accepted screening protocols demonstrates that even when new medical screenings become available, they are not always effectively or equitably deployed.58 By way of example, the lack of standards and quality control surrounding mammography in its initial stages eventually required federal legislation to remedy it.59 Cognizant of these concerns, immediately after the early announcement by the NCI of the National Lung Screening Trial results, Amicus Lung Cancer Alliance relied upon NCCN’s 2011 clinical guidelines to develop quality standards for lung cancer screening. Eventually labeled the “National Framework for 58 See http://www.cdc.gov/minorityhealth/reports/CHDIR11/FactSheets/CCScreening.pdf (last visited Oct. 3, 2013); see also Garth H. Rauscher, et al., Disparities in Screening Mammography Services by Race/Ethnicity and Health Insurance, 21 Journal of Women’s Health 29, 154 (2012), available at http://www.suhichicago.org/files/rauscher%20et%20al%202012.pdf (last visited Oct. 4, 2013). 59 Mammography Quality Standards Act, as amended, 42 U.S.C. 201, Oct. 9, 1998 (P.L. 105-248). 24 Excellence in Lung Cancer Screening and Continuum of Care” (“Framework”), the Framework is divided into three parts. It underscores principles that should be incorporated into any proper equitable surveillance remedy.60 The first part of the Framework alerts members of the public that they could be at risk for lung cancer. Notice is especially important for former smokers, who make up about 60% of lung cancer cases,61 and often erroneously believe they are no longer at risk for lung cancer because they have quit smoking. In fact, the lungs never go back to normal, and the increased risk for lung cancer in a former smoker always remains higher than that of someone who never smoked.62 Thus, it is critical that proper outreach be conducted to ensure that those who need surveillance receive it. The second part of the Framework highlights the standards for high quality screening centers. Screening is a process, not a snapshot. It is essential that surveillance be provided at high quality screening centers. Such centers communicate risks and benefits of screening and pledge to provide patients with 60 See http://www.lungcanceralliance.org/get-information/am-i-at-risk/national- framework-for-lung-screening-excellence.html (last visited Oct. 4, 2013) 61 Centers for Disease Control and Prevention, Cigarette Smoking Among Adults--- United States, 2006 Morbidity and Mortality Weekly Report, 56 MMRW 44, 1157- 1161, Table 2 (2007), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5644a2.htm (last visited Oct. 4, 2013). 62 R. Doll, et al., Mortality in relation to smoking: 50 years’ observation on male British doctors, 328 B.M.J. 7455, 1519 (2004). 25 information about their results in a timely manner. Smoking cessation counseling is also offered to any current smoker who requests screening. High quality screening centers must also follow best practice clinical guidelines in identifying nodules as suspicious or cancerous, and collaborate across a multi-disciplinary clinical team that includes radiologists, oncologists, pulmonologists, pathologists and primary care physicians to ensure that if a suspicious nodule is identified or cancer detected, the patient has access to appropriate follow up care. Part three of the Framework sets forth Lung Cancer Alliance’s commitment to continue supporting the medical community in their efforts to screen responsibly and effectively. It also lays out Lung Cancer Alliance’s commitment to establishing a data collection process. The collection of such data will not only support continuous improvement of lung cancer screening but will also provide valuable information that could contribute in the long term to all aspects of lung cancer research. Numerous centers across the country have been identified that adhere to the principles outlined in the Framework.63 As more of the at-risk public and the medical community become aware of the availability of screening, Amici are hopeful that the number of centers will grow exponentially to meet the needs of 63 http://www.lungcanceralliance.org/get-information/am-i-at-risk/where-should-i- be-screened/lung-cancer-screening-centers/ (last visited Oct. 3, 2013). 26 millions of people at risk for lung cancer. However, unless and until LDCT is reimbursed as a covered benefit by all private insurers, as well as reimbursed by Medicare and Medicaid, it will not be widely available. On that topic, considerable confusion persists regarding the impact of the Affordable Care Act on insurance coverage and on Medicare or Medicaid coverage for LDCT. Because the discussion of that topic in Philip Morris’ Brief is incomplete and potentially misleading, Amici would respectfully take this opportunity to provide the Court with important clarifications. A. The Affordable Care Act Does Not Mandate Automatic Coverage for New Preventive Health Services By All Private Insurers or Medicare. Pursuant to the Patient Protection and Affordable Care Act64 (“ACA”), any preventive service that receives an A or B rating from the USPSTF is deemed an Essential Health Benefit and must be covered by new individual and small group health plans, including those offered in the recently launched state and federal health insurances exchanges (“exchanges”) without a co-payment. Significantly, and frequently misunderstood, this requirement only automatically applies to new plans established after the enactment of the ACA. Under the rationale of preserving existing health coverage choices, Section 64 Patient Protection & Affordable Care Act (Pub.L.111-148, enacted March 23, 2010) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152) (collectively “The Affordable Care Act”). 27 1251(a)(2) of the ACA states: Except as provided in paragraph (3), with respect to a group health plan or health insurance coverage in which an individual was enrolled on the date of enactment of this Act, this subtitle and subtitle A (and the amendments made by such subtitles) shall not apply to such plan or coverage, regardless of whether the individual renews such coverage after such date of enactment. Such plans, referred to as “grandfathered plans,” are specifically exempted from covering new preventive services.65 As the ACA’s implementing regulations expressly state: “The requirements to cover recommended preventive services without any cost-sharing requirements do not apply to grandfathered health plans.” See “Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act,” 45 C.F.R. Part 147, July 19, 2010. Most Americans – 149 million – received their health insurance coverage 65 Also exempted from the automatic coverage requirement are plans negotiated pursuant to Collective Bargaining Agreements. Section 1251 (a)(4)(B)(d) provides: In the case of health insurance coverage maintained pursuant to one or more collective bargaining agreements between employee representatives and one or more employers that was ratified before the date of enactment of this Act, the provisions of this subtitle and subtitle A (and the amendments made by such subtitles) shall not apply until the date on which the last of the collective bargaining agreements relating to the coverage terminates. . . . 28 through employer-based plans66 and many of these plans continue to maintain their “grandfathered” status.67 This means that many people – including those at high risk for lung cancer – will not automatically have access to lung cancer screening through their health plans. It is also crucial to note that Medicare is not required to cover USPSTF recommended screenings automatically. Instead, decisions regarding such coverage are determined pursuant to the Medicare Improvements for Patients and Providers act of 2008 (“MIPPA”).68 Pursuant to MIPPA, the Secretary of Health and Human Services is granted broad authority to modify or eliminate coverage of certain preventive services. While a positive USPSTF recommendation is an important factor in such a decision, it is not dispositive. There are two additional factors that impact coverage decisions. Specifically, the Secretary must determine that such preventive services are “[r]easonable and necessary for the prevention or early detection of an illness or disability” and “[a]ppropriate for individuals entitled to benefits under 66 See The Kaiser Family Foundation and Health Research and Educational Trust, Employer Health Benefits-2013 Annual Survey, at p. 43, available at http://kaiserfamilyfoundation.files.wordpress.com/2013/08/8465-employer-health- benefits-20131.pdf (last visited Oct. 3, 2013). 67 Plans maintain their grandfathered status so long as there is no major change in coverage or consumer cost. See https://www.healthcare.gov/glossary/grandfathered-health-plan/ (last visited Oct 4, 2013). 68 Medicare Improvement for Patients & Providers Act of 2008, P.L. 110-275 29 Part A or enrolled under Part B.”69 A final decision on coverage of LDCT screening by Medicare is reached only after a formal National Coverage Determination (“NCD”) is completed. The NCD process can take up to two years to complete.70 Amici are optimistic that most private plans will voluntarily opt to cover LDCT screening, especially in light of peer-reviewed studies demonstrating its cost effectiveness.71 Amici are also optimistic that Medicare will cover LDCT, especially given studies that show the cost for treating lung cancer is one of Medicare’s highest costs.72 However, even if LDCT screening were fully covered by private plans or Medicare, it would not be accurate to say the coverage was being made available for “free.” In the case of private plans, the tab for such screening is shared by other health plan subscribers. This cost on an individual basis is nominal. However, as a cost to the overall health care infrastructure, it is substantial. Similarly, with regard to Medicare coverage, the cost of LDCT screening is hardly “free.” It is paid for by every taxpayer in the country. 69 Id. at Sec. 101(a). 70 See Centers for Medicare & Medicaid Services, Guidance for Public, Industry and CMS Staff, http://www.cms.gov. 71 B. Pyenson, et al., An Actuarial Analysis Shows That Offering Lung Cancer Screening As An Insurance Benefit Would Save Lives At Relatively Low Cost, 31 Health Affairs 770-779 (2012). 72 See K. Robin Yabroff, et al., Cost of Care for Elderly Cancer Patients in the United States, 100 Journal of the National Cancer Institute 9, 633-641 (2008); see also id. at 636 (concluding that “aggregate costs of care [is] highest for patients diagnosed with lung cancer,” and estimating its cost at $4.2 billion). 30 B. Coverage of LDCT by Medicaid Is Left to the Individual States For the nation’s most vulnerable and poorest communities, Medicaid continues to offer the only health care safety net. Medicaid programs are administered by the individual states. To qualify for federal Medicaid dollars, states must agree to cover certain populations73 and cover a specific set of baseline benefits.74 The ACA does not require states to adjust their baseline benefit plan to cover new preventive health services for those populations that were previously eligible for Medicaid. The ACA had sought to mandate expansion of Medicaid to cover a broader category of poor – including childless adults and individuals and families with income that was up to 133% of the poverty level, instead of 100%. For these newly eligible beneficiaries, the ACA requires coverage that includes all new Essential Health Benefits, including new preventive services.75 On June 28, 2012, the Supreme Court upheld most of the ACA.76 However, it struck down the provision that mandated state expansion of Medicaid coverage. Instead, the decision to expand Medicaid would have to be left to the individual 73 http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By- Topics/Eligibility/Eligibility.html (last visited Oct. 3, 2013). 74 http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By- Topics/Benefits/Medicaid-Benefits.html (last visited Oct. 3, 2013). 75 http://www.medicaid.gov/AffordableCareAct/Provisions/Benefits.html (last visited Oct. 3, 2013). 76 See Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566 (U.S. 2012). 31 states.77 As of September 30, 2013, only half the states had opted to expand Medicaid.78 Among the states that have “opted out” are several states with some of the highest lung cancer rates in the country. These include: Alabama, Alaska, Georgia, Louisiana, Maine, Mississippi, North Carolina, and South Carolina.79 Only newly covered Medicaid beneficiaries are entitled to receive benefits consistent with the ACA. Thus, because these states have “opted out,” many poor adults who would benefit from screening will be denied access to LDCT. Lung cancer is strongly associated with tobacco use. And tobacco use is strongly associated with low socioeconomic status.80 Among adults who live below the federal poverty level 29.0% smoke, compared to 17.9% of those at or above the poverty level.81 Smoking rates vary by education level. Among adults over age 25, individuals with a GED have the highest prevalence of current smoking (45.3%), followed by those whose highest level of education is grades 9, 10 or 11 (34.6%). 77 Id. 78 See Report by the Kaiser Family Foundation, Status of State Action on Medicaid Expansion Decisions, as of September 30, 2013, available at http://kff.org/health- reform/state-indicator/implications-of-state-action-on-the-medicaid-expansion- decision/ (last visited Oct. 3, 2013). 79 http://www.cdc.gov/cancer/lung/statistics/state.htm (last visited Oct. 3, 2013). 80 Centers for Disease Control and Prevention, Cigarette smoking - United States, 1965-2008, 60 MMWR (Suppl.), 109–113 (2011). 81 Centers for Disease Control and Prevention, Current cigarette smoking among adults — United States, 2011, 61 MMWR 44, 889–894 (2012). 32 By comparison, individuals with an undergraduate degree (9.3%) or graduate degree (5.0%) smoke at the lowest rates.82 For those at high risk for lung cancer who can either pay out of pocket for screening or who will be lucky enough to have health insurance or Medicare coverage, LDCT will transform lung cancer into a survivable disease. But for those without coverage, including many in the vulnerable communities that continue to be targeted by tobacco industry marketing tactics, dying from lung cancer will continue to be a fact of life. CONCLUSION For the foregoing reasons, Amici urge the Court to find that a cause of action exists for medical monitoring in New York State, and hold that Plaintiffs’ claims are timely. Dated: New York, New York October 7, 2013 Respectfully Submitted, KELNER & KELNER, ESQS. Attorneys for Amici Curiae American Legacy Foundation and Lung Cancer Alliance By:_______________________ Joshua D. Kelner jkelner@kelnerlaw.com 82 Id. 33 140 Broadway, 37th Floor New York, NY 10005 Ph.: 212.425.0700 Fax: 212.425.0007