Updates on Screening from the USPSTF: 2018

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1 Updates on Screening from the USPSTF: 2018 Ronald Adler, MD, FAAFP Associate Professor Family Medicine and Community Health UMass Medical School February 7, 2019 Pri Med South Annual Conference Ft. Lauderdale, FL USPSTF Screening Recommendations: General Caveats and Disclaimers Except where noted, screening recommendations apply to asymptomatic people of average risk. Recommendations are based on evidence of benefits and harms and an assessment of the balance. Costs are NOT considered. Clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decision making to the specific patient or Screening for Syphilis in Pregnant Women Screening for Syphilis in Pregnant Women: Rationale Rising incidence Transmission to fetus may occur at any time during pregnancy or birth Significant infant morbidity and neonatal mortality Accurate diagnostic screening algorithms available Safe, effective, and acceptable treatment available 70% of infants with congenital syphilis are born to women who received prenatal care Screening rates are high, BUT early screening rates are low (20% of women screened only at the time of delivery) JAMA September 4, 2018 JAMA. 2018;320(9): doi: /jama

2 Screening for Syphilis in Pregnant Women: Rationale Rising incidence Transmission to fetus may occur at any time during pregnancy or birth Significant infant Syphilis morbidity incidence and neonatal Congenital mortality syphilis Accurate Year diagnostic per 100,000 screening algorithms incidence available per 100,000 women live births Safe, effective, and acceptable treatment available % of infants with congenital syphilis are born to women who received 2016 prenatal care Screening rates are high, BUT early screening rates are low (20% of women screened only at the time of delivery) Screening for Syphilis in Pregnant Women: Rationale Rising incidence Transmission to fetus may occur at any time during pregnancy or birth Significant infant morbidity and neonatal mortality Accurate diagnostic screening algorithms available Stillbirth Safe, effective, and acceptable treatment available Neonatal death 70% of infants with congenital syphilis are born to women who received prenatal care Bone deformities Screening rates are high, BUT early screening Neurologic rates are impairment low (20% of women screened only at the time of delivery) Screening for Syphilis in Pregnant Women: Rationale Rising incidence 2 Step process: Transmission to fetus may occur at any time during pregnancy or birth Significant infant morbidity and neonatal mortality Accurate diagnostic screening algorithms available Safe, effective, and acceptable treatment available 70% of infants with congenital syphilis are born to women who received prenatal care Parenteral PCN Screening rates are high, BUT early screening rates are low (20% of women screened only at the time of delivery) treponemal and non treponemal tests Screening for Syphilis in Pregnant Women: Rationale Rising incidence Transmission to fetus may occur at any time during pregnancy or birth Significant infant morbidity and neonatal mortality Late Dx may not allow for successful Tx. Accurate diagnostic screening algorithms available Therefore: Screen EARLY Safe, effective, and acceptable treatment available 70% of infants with congenital syphilis are born to women who received prenatal care Screening rates are high, BUT early screening rates are low (20% of women screened only at the time of delivery) Not USPSTF recommendation, but suggested by others (CDC, AAP, ACOG): repeat screening, e.g. at 28 weeks and at delivery for higher risk women, such as those living in high prevalence areas, those living with HIV, and those with Hx of incarceration or commercial sex work.

3 Cervical Cancer Screening Recommendations MMWR Weekly / October 5, 2018 / 67(39); JAMA August 21, 2018 JAMA. 2018;320(7): doi: /jama Cervical Cancer Screening The first and still the best cancer screening program First described by Georgios Papanikolaou in Ignored until 1941! (There was no paradigm for it.) Proof of concept: Early detection saves lives. Slow growing, detectable, treatable precursor lesions Cervical Cancer Screening Recommendations Age (years) < > 65 Recommen dation DO NOT SCREEN Cytology q 3 years Cytology q 3 years or hrhpv q 5 years or Co Test q 5 years DO NOT SCREEN* Grade D A A D D: Do not screen women if Hx of hysterectomy with removal of cervix and no Hx of cervical cancer or CIN 2 *Assuming adequate prior screening JAMA August 21, 2018

4 Age 30 65: Which strategy? Strategy Cervical cancer mortality rate per 1000 women NNS (to prevent 1 cervical cancer death) False Positives No Screening 8.34 Cytology q 3 years hrhpv q 5 years Co testing q 5 years Cervical Cancer Screening Recommendations: What s NOT Addressed Triage strategies for women with positive hrhpv results Economic implications of alternative strategies Preferences of women Participation in regular screening has a far greater effect on cervical cancer morbidity and mortality than which of the 3 recommended screening strategies is chosen. Cervical Cancer Screening: Research Needs and Gaps Identify effective strategies to reach inadequately screened and unscreened women: Most US cervical cancer deaths occur among women who are poor, of color, non US born, or living in rural and remote areas. Evaluate potential role of self collection for HPV testing. Understand the effect of HPV vaccination, especially vis à vis HPV testing alone. Refine follow up strategies per screening results. Screening for Osteoporosis to Prevent Fractures Women 65 years old Women < 65 at increased risk JAMA June 26, 2018 JAMA. 2018;319(24): doi: /jama Men

5 Osteoporosis Prevalence Prevalence increases dramatically with age: Age y: 5.1% Age 80 y: 26.2% Race/Ethnicity Variations: Mexican American: 13.4% Non Hispanic white: 10.2% Non Hispanic black: 4.9% Asymptomatic until a Fx occurs, therefore Preventing fractures is the main goal of osteoporosis screening Osteoporosis Disease Burden: Fractures Osteoporotic fractures (esp. hip) associated with: Limited ambulation Chronic pain and disability Loss of independence Decreased quality of life 1 year mortality rate: 21 30% Women (71%): Higher rates at every age Men (29%): Higher Fx related mortality rates Image source: Osteoporosis Screening Methods Primary test: Central DXA = Dual energy X ray Absorptiometry Preferred because guidelines use BMD derived from central DXA to define treatment thresholds Alternatives: Peripheral DXA Quantitative ultrasound (QUS) Osteoporosis: Benefits of Early Detection and Treatment Screening decreases hip fracture rates (Though not other fracture types) Drug therapies decrease fractures in post menopausal women with osteoporosis (Though not in men) Harms are trivial

6 Osteoporosis: USPSTF Conclusions and Recommendations Assessing Osteoporosis Fracture Risk The USPSTF concludes that The USPSTF Risk Factors Clinical Risk Assessment Tools the net benefit of screening for osteoporosis in women 65 y is at least moderate. [moderate certainty] the net benefit of screening for osteoporosis in postmenopausal women < 65 y who are at increased risk of osteoporosis is at least moderate. [moderate certainty] current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis for men. recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 y. [B recommendation] recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women < 65 y at increased risk of osteoporosis. [B recommendation] makes no recommendation re: screening men for osteoporosis because of insufficient evidence. If it is offered, patients should understand the uncertainty about the benefits and harms. [I statement] Advanced age Female gender Post menopausal Smoking Excessive alcohol consumption Low body weight Parental Hx of hip Fx FRAX SCORE ORAI OSIRIS OST FRAX for white men: Age 65: 5.0% Age 80: 8.4% Strategy: Screen women < 65 yo if they have a 10 year FRAX risk of MOF* > that of a 65 yo white woman without additional risk factors (=8.4%) JAMA June 26, 2018 *MOF: major osteoporotic Fx Prostate Cancer Screening Prostate Cancer Screening: USPSTF Conclusion/Recommendation C: y D: 70 y JAMA May 8, 2018 JAMA. 2018;319(18): doi: /jama SDM and should include discussion of the potential benefits and harms of screening Clinicians should not screen men who do not express a preference for screening. JAMA May 8, 2018

7 USPSTF Conclusion/Recommendation Screening offers a small potential benefit of reducing the chance of death from prostate cancer in some men. However, many men will experience potential harms of screening, including false positive results that require additional testing and possible prostate biopsy; overdiagnosis and overtreatment; and treatment complications, such as incontinence and erectile dysfunction. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the balance of benefits and harms on the basis of family history, race/ethnicity, comorbid medical conditions, patient values about the benefits and harms of screening and treatment specific outcomes, and other health needs. Decision Aid Decision Aids per Cochrane People who use decision aids Report higher levels of satisfaction Are less likely to remain undecided Feel more knowledgeable, informed, and clear about their values Take a more active role in listening Are more likely to make values congruent choices Have a more accurate perception of their health risks Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes Rovner M, Llewellyn Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews 2017, Issue 4. Art. No.: CD DOI: / CD pub5 Prostate: From Adler R: Cancer Screening Decisions: A Patient Centered Approach. Philadelphia: Wolters Kluwer, 2018 AUA Prostate Cancer Screening Guideline Published 2013; Reviewed and Validity Confirmed 2018 For men ages 55 to 69 years the decision to undergo PSA screening involves weighing the benefits of reducing the rate of metastatic prostate cancer and prevention of prostate cancer death against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends SDM for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man's values and preferences. (Standard; Evidence Strength Grade B) To reduce the harms of screening, a routine screening interval of two years or more may be preferred over annual screening in those men who have participated in SDM and decided on screening. As compared to annual screening, it is expected that screening intervals of two years preserve the majority of the benefits and reduce overdiagnosis and false positives. (Option; Evidence Strength Grade C) Intervals for rescreening can be individualized by a baseline PSA level. The Panel does not recommend routine PSA screening in men age 70+ years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C) Some men age 70+ years who are in excellent health may benefit from prostate cancer screening.

8 Screening for Ovarian Cancer Ovarian Cancer: Population and Screening Tests Considered JAMA February 13, 2018 JAMA. 2018;319(6): doi: /jama Asymptomatic women not known to have a high risk hereditary cancer syndrome Screening tests: Transvaginal ultrasound Serum CA 125 Pelvic examination Risk Assessment Family Hx may be helpful Clinical Sx (abdominal pain, bloating, constipation, urinary Sx, back pain, fatigue) are too non specific to be useful for risk stratification. Ovarian Cancer Screening: USPSTF Findings Screening does not reduce ovarian cancer mortality. The harms from ovarian screening are at least moderate and may be substantial, including unnecessary surgery for women who do not have cancer. Screening for CVD with EKG (resting or exercise) < 10% 10 year risk Harms > Benefits D > 10% 10 year risk JAMA June 12, 2018 JAMA. 2018;319(22): doi: /jama

9 Screening for CVD with EKG (resting or exercise) Screening for Atrial Fibrillation with EKG Low Risk patients (10 year risk < 10%) 5x more likely to get another cardiac test or consultation Angiography rates: % Serious harm rate for angiography: 1.7% No difference in 1 year rates of death, re vascularization, or hospitalization for a cardiac cause Intermediate/High Risk Patients (10 year risk > 10%) Insufficient evidence Similar harms anticipated D I The harms of diagnostic follow up and treatment prompted by abnormal ECG results are well established and include misdiagnosis and invasive testing. JAMA August 7, 2018 JAMA. 2018;320(5): doi: /jama Screening for Adolescent Idiopathic Scoliosis Forward bend test, scoliometer, etc. JAMA January JAMA. 2018;319(2): doi: /jama does not apply to children and adolescents presenting for evaluation of back pain or obvious deformities in spinal curvature. A A B C Conclusions Do: Screen for syphilis in all pregnancies as EARLY as possible. Screen women age for cervical cancer. Offer osteoporosis screening to women > 65 y and younger women at increased risk. Offer PSA testing to men age 55 69, but only in the setting of SDM. Don t screen for ovarian cancer. screen for CVD with EKG. screen for cervical cancer among women younger than 21 or older than 65. screen for prostate cancer among men older than 69. order PSA testing in the absence of patient expressed preference for this after SDM.

10 Screening for Lung Cancer: Rationale 3rd most common cancer Leading cause of cancer related death in the US Smoking is primary risk factor, accounting for ~ 85% of all cases Smoking prevalence has decreased, but ~ 37% of US adults are current or former smokers Incidence increases with age; most common in persons aged 55 years or older Screening for Lung Cancer, USPSTF: Grade B* Population: Asymptomatic adults aged 55 to 80 y who have a 30 pack year smoking history and currently smoke or have quit smoking within the past 15 y Recommendation: Screen annually for lung cancer with lowdose computed tomography (LDCT). Discontinue screening when the patient has not smoked for 15 y or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. *Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;160(5): Concerns re: USPSTF Recommendation Based on NLST only; other trials have not shown benefit: Different age range cf. NLST (55 80 vs ) [NLST Mean: 61] NLST conducted in centers of excellence, where radiology and lung cancer treatment factors likely superior to community care outside of trial *Humphrey LL, Deffebach M, Pappas M, Baumann C, Artis K, Mitchell JP, Zakher B, Fu R, Slatore CG. Screening for lung cancer with low dose computed tomography: a systematic review to update the US Preventive services task force recommendation. Ann Intern Med Sep 17;159(6): doi: / PMID: * National Lung Screening Trial (NLST) Eligibility: Age years 30 pack years cigarette smoking If former smoker, quit < 10 years ago Aug 2002 Apr 2004: enrolled 53,454 people at high risk; Mean age: 61 Followed through Dec 2009 Randomized to annual screening with LDCT or PA CXR 90% screening adherence rate Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al; National Lung Screening Trial Research Team. Reduced lung cancer mortality with low dose computed tomographic screening. N Engl J Med. 2011; 365: [PMID: ]

11 NLST Findings 20% decrease in lung cancer mortality: 3 per 1000 after 3 annual screens (f/u 6.5 years) NNS: 320 to prevent 1 lung cancer death 365 false positives per 1000 after 3 annual screens 25 unnecessary biopsies 3 with major complications 96.4% of positives are False Positives 1.38 overdiagnosed lung cancer cases per lung cancer death avoided* *Patz EF, Pinsky P, Gatsonis C, et al. Overdiagnosis in Low Dose Computed Tomography Screening for Lung Cancer. JAMA Intern Med. 2014;174(2): doi: /jamainternmed Screening for Lung Cancer Benefits Decreased lung cancer mortality 3 per 1000? Decreased all cause mortality intrapulmonary lymph nodes; noncalcified granulomas Harms High rates of false positives and incidental findings W/u of these causes psychological, physical, and financial harms Overdiagnosis of lung cancer NLST: 18.5% DLCST: 67.2% Development of radiation induced cancers (1 per 2500 having 3 scans) Screening for Lung Cancer: Evolution 2011: NLST published 2014: USPSTF issues Grade B recommendation ACA requires coverage April 30, 2014: MEDCAC* votes against coverage because benefits not clearly demonstrated to exceed harms November 2014: CMS announces plans to cover it February 5, 2015: CMS issues national coverage determination (NCD) with requirement for shared decision making Specifies ages (NLST mean age: 61) *Medicare Evidence Development & Coverage Advisory Committee Medicare Coverage Requirements Medicare beneficiaries must meet all of the following criteria: Be years of age; Be asymptomatic (no signs or symptoms of lung cancer); Have a tobacco smoking history of at least 30 pack years; Be a current smoker or one who has quit smoking within the last 15 years; and, Receive a written order for lung cancer screening with LDCT that meets the requirements described in the NCD. Written orders for lung cancer LDCT screenings must be appropriately documented in the beneficiary s medical record, and must contain the following information: Date of birth; Actual pack year smoking history (number); Current smoking status, and for former smokers, the number of years since quitting smoking; A statement that the beneficiary is asymptomatic (no signs or symptoms of lung cancer); and, The National Provider Identifier (NPI) of the ordering practitioner.

12 Counseling and Shared Decision Making Visit (G0296) Before the first lung cancer LDCT screening occurs, the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit that includes the following elements and is appropriately documented in the beneficiary s medical records: Must be furnished by a physician or qualified non physician practitioner (meaning a Physician Assistant (PA), Nurse Practitioner (NP), or Clinical Nurse Specialist (CNS); and Must include all of the following elements: Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, a specific calculation of cigarette smoking pack years; and if a former smoker, the number of years since quitting; Shared decision making, including the use of one or more decision aids, to include benefits and harms of screening, follow up diagnostic testing, over diagnosis, false positive rate, and total radiation exposure; Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities, and ability or willingness to undergo diagnosis and treatment; Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions; and, If appropriate, the furnishing of a written order for lung cancer screening with LDCT. Written orders for subsequent annual LDCT screens may be furnished during any appropriate visit with a physician or qualified non physician practitioner (PA, NP, or CNS). Counseling and Shared Decision Making Visit (G0296) G0296 Counseling visit to discuss need for lung cancer screening (LDCT) using low dose CT scan (service is for eligibility determination and shared decision making) As long as the NCD requirement for the counseling and shared decisionmaking visit are met, the counseling visit may be billed on the same day as a medically necessary E/M visit or an annual wellness visit with the 25 modifier. The shared decision making visit is not subject to coinsurance or deductibles. More details regarding this topic is addressed in the ACR 2016 MPFS comment letter to CMS. The code to use for a SDM visit is G0296 (counseling visit to discuss need for lung cancer screening [LDCT]). This is a 15 minute code with reimbursement of $69.65 in the hospital out patient setting and $28.64 in a physician s office. It can be billed on the same day as an E/M visit, provided medical necessity is met. If this occurs, it should be billed with a 25 modifier added to the E/M service. The time to perform the E/M service is exclusive of the time to perform the SDM. Since this is a preventive service benefit, no patient copays are applicable Lung Cancer Low Dose CT Scan From Adler R: Cancer Screening Decisions: A Patient Centered Approach. Philadelphia: Wolters Kluwer, 2018 Lung Cancer Screening: Recent Issues Among patients experiencing SDM, ~40% decline screening. 1,2 SDM rarely precedes screening in a privately insured 3 and Medicare population: 2 10%! SDM conversations are typically inadequate, rarely addressing harms. 3 Rates of overdiagnosis may be much higher than NLST (18.5%): DLCST: 67.2% 4 1. Kinsinger LS, Anderson C, Kim J, et al. Implementation of lung cancer screening in the Veterans Health Administration. JAMA Intern Med. 2017;177(3): doi: /jamainternmed Goodwin JS, Nishi S, Zhou J, Kuo Y F. Use of the shared decision making visit for lung cancer screening among Medicare enrollees [Published online January 14, 2019]. JAMA Intern Med. doi: /jamainternmed Brenner AT, Malo TL, Margolis M, et al. Evaluating shared decision making for lung cancer screening. JAMA Intern Med. 2018; 178(10): doi: /jamainternmed doi: /jamainternmed Heleno B, Siersma V, Brodersen J. Estimation of Overdiagnosis of Lung Cancer in Low Dose Computed Tomography Screening: A Secondary Analysis of the Danish Lung Cancer Screening Trial. JAMA Intern Med. 2018;178(10): doi: /jamainternmed