March 4, 2016 BY ELECTRONIC DELIVERY

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1 BY ELECTRONIC DELIVERY Sean Cavanaugh Deputy Administrator Director, Center for Medicare Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD cc: Jennifer Wuggazer Lazio, F.S.A., M.A.A.A. Director Parts C & D Actuarial Group Office of the Actuary Re: Advance Notice of Methodological Changes for Calendar Year (CY) 2017 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2017 Call Letter ( draft 2017 Call Letter ) Dear Mr. Cavanaugh: The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services (CMS s) draft 2017 Call Letter. 1 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. Our members novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO strongly supports CMS s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and vaccines for Medicare beneficiaries in MA and Part D plans. To further improve access to crucial therapies and immunizations for these patients, we urge CMS to consider the following comments, discussed in more detail below: CMS should finalize the proposal to update the specialty tier cost threshold, and regularly update the threshold, as appropriate, in order to ensure the specialty tier does not discriminate against vulnerable beneficiaries. Additionally, CMS should 1 Centers for Medicare & Medicaid Services (CMS), Advance Notice of Methodological Changes for Calendar Year (CY) 2017 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2017 Call Letter (Feb. 19, 2016), available at: Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2017.pdf.

2 Page 2 of 10 review specialty tiers to confirm they are not likely to substantially discourage enrollment by certain Part D-eligible individuals. CMS should not include a link on the Medicare Plan Finder website to the Medicare Drug Spending Dashboard, as it may serve to mislead patients with regard to the cost of prescription therapies. CMS should ensure that the timeframe and process for formulary updates reasonably allows for the addition of new therapies. CMS should discourage plans from using coinsurance in ways that will unduly limit access to care for patients with severe and complex diseases. CMS should ensure a timely and transparent adjudications process that provides patients with appropriate access to needed drugs. CMS should continue its efforts to improve access to vaccines and, as part of these efforts, require MA plans to deem contracted pharmacy providers as in-network providers for immunizations provided consistent with state scope-of-practice laws. CMS should evaluate access to specialty pharmacies in considering network adequacy and patient access issues. CMS should finalize the removal of the High Risk Medication (HRM) measure from the Star Ratings. CMS should add lung cancer screening to the Part C Star Ratings Measures. I. CMS Should Increase the Specialty Tier Eligibility Cost Threshold for 2017 and Should Continue to do so in Future Years to Ensure the Specialty Tier Does Not Discriminate against Vulnerable Beneficiaries. Because of the distinctive cost-sharing structure of the Part D benefit, patients prescribed drugs or biologicals on a plan s specialty tier are uniquely at risk for large out-ofpocket costs. Although only a small percentage of Medicare beneficiaries reach the coverage gap or donut hole during a plan year, patients needing therapies on a plan s specialty tier are more likely to encounter the donut hole earlier in the calendar year and to incur the donut hole s substantial out-of-pocket expenses all at once. BIO is concerned about insurance designs that result in high out-of-pocket costs for vulnerable beneficiaries, which can effectively limit access to therapies. Indeed, BIO believes that the specialty tier may operate in a discriminatory manner by imposing high cost-sharing on Medicare s most vulnerable beneficiaries. Accordingly, BIO commends CMS for its proposal to increase the specialty tier cost threshold for CY 2017 from the $600 threshold established for CY Under CMS s plan for 2017, plans would be allowed to place a drug or biological on the specialty tier of the formulary, and thus subject it to a higher coinsurance, if the therapy has a negotiated price of $670 per month or more. 2 We believe this increased threshold furthers CMS s original intent in creating the specialty tier, which, as we understand it, was at least in part to establish more flexibility in plan benefit design. Importantly, by raising the threshold, CMS also will better ensure that vulnerable patients can access medically necessary care. 2 Id. at pp

3 Page 3 of 10 BIO urges CMS to regularly evaluate and, as appropriate, raise the specialty tier cost threshold to protect vulnerable patients access to therapies. We note that the methodology that CMS relied upon to reach the $670 figure namely, applying the annual percentage increase used in the Part D benefit parameter updates to the existing threshold appears to be a sound one; we urge CMS to employ such a reasonable methodology to evaluate specialty tier cost thresholds in each forthcoming year and not to permit multi-year delays in reviewing and updating the cost threshold in the future. Lastly, BIO continues to have concerns with CMS s review of Part D prescription drug plan and MA-PD (i.e., MA plans that provide prescription drug coverage) prescription drug benefit package data to determine whether applicable coinsurance rates are discriminatory. The Part D statute specifically states that the Secretary can only approve a plan if the design of the plan and its benefits are not likely to substantially discourage enrollment by certain Part D-eligible individuals. 3 It is critical that CMS carefully review the specialty tier which has the greatest potential to be discriminatory, particularly given that patients are barred from appealing cost-sharing decisions of that tier in examining acceptable costsharing thresholds. We support CMS s efforts to identify potentially discriminatory and misleading practices, such as the use of decreased or no deductible only for some tiers. We further recommend that CMS limit the flexibility in specialty tier cost-sharing flexibility so that beneficiaries are not subjected to onerously high cost-sharing requirements. II. The Medicare Drug Spending Dashboard Does Not Provide Relevant Data to Patients with regard to Their Individual Enrollment Decisions, and May Serve to Mislead, Rather than Clarify, Patients Considerations. In the draft 2017 Call Letter, CMS proposes to add a hyperlink on the Medicare Plan Finder on Medicare.gov to the Medicare Drug Spending Dashboard in time for the 2017 open enrollment period. 4 BIO appreciates the underlying intent of this proposal, which we believe is to improve the information that patients have prior to making enrollment decisions. However, directing patients to the Dashboard does not fulfill this goal because the information included in the Dashboard is not relevant to individual patient decisionmaking. For example, the Dashboard cannot provide patients with information about their likely out-of-pocket costs if they enroll in a particular plan, nor can it provide information related to other aspects of obtaining access to covered therapies (e.g., any utilization management restrictions a plan may have in place, exceptions/appeals processes). Instead, the Dashboard provides only an incomplete assessment of prescription drug costs to Medicare, since it does not take into account the discounts and rebates negotiated between manufacturers and Part D plan sponsors. Thus, we strongly urge CMS not to include a link on the Medicare Plan Finder website to the Dashboard, as it is inaccurate and may serve to mislead patients with regard to the cost of prescription therapies. Patients may already be overwhelmed by the data they must analyze and synthesize before making an enrollment decision: CMS should help to streamline the process, not distract patients from the relevant information. 3 SSA 1860D-11(e)(2)(D)(i). See also 42 C.F.R (b)(2)(i). 4 Draft 2017 Cal Letter at p. 193.

4 Page 4 of 10 III. The Timeframes and Processes for Formulary Updates Should Support the Inclusion of New Therapies. BIO is concerned that the timeframes and processes for updating prescription drug formularies for CY 2017 will hinder the inclusion of new therapies on formularies. CMS notes in the draft 2017 Call Letter that it will provide the first release of the CY 2017 formulary reference file (FRF) in March and the out-of-pocket cost (OOPC) model tool in April and will provide a second release of the FRF in May to allow plan sponsors to have upto-date FRF information prior to their formulary submission to CMS. CMS explains, however, that because of the short timeframe between the May FRF release and the formulary submission deadline, CMS will not update the OOPC model with any newly added drugs from the May FRF. CMS also proposes to limit the ability of plans to make formulary changes during the summer formulary update window. 5 While BIO appreciates that CMS will allow the addition of new drugs to the summer release of the FRF, we are concerned that these first two policies, taken together, will limit the ability of plan sponsors to add new therapies to their formularies. We also believe that this policy appears to undermine the longstanding requirement that plans review all new Food and Drug Administration (FDA)-approved drug products (and indications) for inclusion on their formularies on a year-round basis (i.e., within 180 days of their release on the market). 6 Accordingly, we urge CMS to both update the OOPC model, including to reflect newly added drugs from the May FRF, and to ensure/clarify that Part D plan sponsors may easily expand formularies by adding drugs to their formularies, reducing copayments or coinsurance by placing a drug on a lower cost-sharing tier, or deleting utilization management requirements at any time during the year. In addition, we urge CMS to continue to reiterate that Part D plans are not required to wait until a new Part D drug appears on the FRF before including the drug on their formularies, and that, in fact, Part D plans cannot deny coverage to new Part D drugs simply because they have not yet been added to the FRF. 7 BIO would also like to take this opportunity to re-articulate our concerns with respect to the existing OOPC standard. As CMS is aware, a plan-specific, per-member-per month (PMPM) OOPC estimate is used to determine whether a sponsor is in compliance with the requirement that there is a meaningful difference between plans offered in the same geographical area. 8 BIO continues to be concerned that this methodology, as well as the data currently used to calculate OOPC, can incentivize plan sponsors to undermine the inclusiveness of their formulary and thus risk sufficient patient access to vital prescription 5 Draft 2017 Call Letter, at pp CMS, Prescription Drug Manual, Ch. 6, ( [t]he P&T committee will make a reasonable effort to review a new FDA approved drug product (or new FDA approved indication) within 90 days and will make a decision on each new FDA approved drug product (or new FDA approved indication) within 180 days of its release onto the market, or a clinical justification will be provided if this timeframe is not met. ). 7 An April 8, 2014 CMS Frequently Asked Questions document provided the following guidance: Q: Can Part D sponsors cover drugs that are not on the FRF? A13. Yes. In the event that a sponsor has determined a drug product meets the definition of a Part D drug, the sponsor can cover the drug at point-of-sale and market the addition. However, we expect the sponsor to 1) submit an FRF add request for the missing drug, and 2) add the drug to their HPMS formulary file(s) during the next available submission window. See CMS (April 8). Formulary Reference File Frequently Asked Questions. Q13, p. 5, available at: Coverage/PrescriptionDrugCovContra/RxContracting_FormularyGuidance.html. 8 CMS Call Letter. February 15, At 114. Available at: Plans/MedicareAdvtgSpecRateStats/downloads/Advance2014.pdf.

5 Page 5 of 10 medications in order to meet the meaningful difference standard. Accordingly, BIO supported CMS s proposal in the draft CY 2014 Call Letter to update the methodology for calculating OOPC for purposes of CY 2015 so that Medicare Current Beneficiary Survey (MCBS) cohort drugs not on plan formularies would be subject to the cost-sharing of the Part D sponsor s exception tier. 9 BIO also supports the use of the latest available MCBS data in the OOPC calculation (CY 2016 calculations are based on the outdated CY 2010/2011 data set). 10 While not addressed in the draft 2017 Call Letter, BIO urges CMS to follow through with its proposal to update the OOPC methodology, and to do so for 2017 in order to ensure that the OOPC calculation is an accurate reflection of current patterns of spending and utilization. Finally, BIO recommends that CMS not pursue the potential to include an informational column on the FRF that would periodically track price changes for FRF drugs, as described in the draft 2017 Call Letter. We make this recommendation based on the fact that information on pricing changes is not relevant in the context of the purpose of the FRF or with regard to how it is utilized (i.e., as a point of reference to Part D plan sponsors as they construct and submit their formularies to CMS for review). Moreover, the general pricing information that CMS may be able to track will not be germane to Part D plan sponsors because they negotiate independently, and directly, with manufacturers to obtain discounts and rebates on prescription therapies. Thus, because introducing such an additional column would not improve the utility of the FRF to Part D plan sponsors or the Agency, we recommend CMS not pursue this activity as it is not a productive use of Agency resources. IV. Co-insurance in the Part D Non-Preferred Drug Tier Can Unduly Limit Access to Care for Patients with Severe and Complex Diseases. BIO continues to be concerned that Part D sponsors may utilize forms of cost-sharing that impede vulnerable beneficiaries access to medically necessary therapies. CMS serves a critical role in safeguarding against such practices through its rule-making and issuance of general guidance, among other actions. Thus, we are concerned that CMS has encourage[d] Part D sponsors to consider using coinsurance rather than co-pays for the non-preferred drug tier. CMS states that a coinsurance (versus copay) structure will provide a more equivalent benefit to those beneficiaries who use less expensive generic medications that are placed on a non-preferred drug tier. 11 However, we believe that this type of cost-sharing will have potentially-significant negative consequences for patients with severe and complex diseases. Indeed, we are concerned that the use of coinsurance in the non-preferred drug tier may create additional hurdles to access for an already vulnerable population of beneficiaries. Coinsurance requirements, compared to copayments, obligate patients to pay a much higher amount out of pocket. Since literature demonstrates a clear link between higher out-of-pocket costs and lower patient adherence to therapy, BIO is concerned that the Agency s encouragement of the use of coinsurance will undermine 9 See id. at Draft 2017 Call Letter at p Draft 2017 Call Letter at p. 188.

6 Page 6 of 10 efforts to improve patient adherence across the Part D program. 12 Moreover, lower patient adherence can lead to poor health outcomes in the short- and longer-term, as well as higher overall health expenditures (e.g., due to additional hospitalizations, physician office visits, and/or surgical interventions). We note that CMS suggests that its position with respect to the use of coinsurance in the non-preferred drug tier is based, at least in part, on its expectations regarding the proportion of generic drugs versus brand drugs in the non-preferred tier. However, we believe that CMS can address its concerns regarding the costs of generic drugs in alternative, narrower ways that would not have the same negative consequences on beneficiaries access to a much broader range of therapies. Hence, BIO urges CMS to clarify its policy position and help ensure that sponsors do not, in fact, use coinsurance in a manner that discriminates against the most vulnerable beneficiaries. V. Adjudication Processes Must Be Timely in Order to Ensure That Beneficiaries Have Access to Clinically Appropriate Therapies. BIO supports CMS s ongoing efforts to improve clinical decision-making for Part D coverage determinations, including by ensuring effective adjudication processes. Strong adjudication processes are a fundamental component of providing Medicare beneficiaries with meaningful access to benefits. Where the adjudications process is not providing appropriate access to care or operating in accordance with required timeframes, this can lead to significant delays in beneficiaries access to care, result in inappropriate denial of care, and increase beneficiaries out-of-pocket costs. In turn, each of these consequences can negatively impact patient adherence to therapies and their short- and long-term health outcomes. Indeed, as noted in the draft 2017 Call Letter, CMS established significantly shorter adjudication timeframes under Part D, as compared to under MA, given the risk of adverse clinical outcomes if access to [a] drug is delayed. 13 In light of this significant risk, BIO expresses caution with regard to CMS s consideration of rulemaking that would allow extensions to Part D adjudication timeframes in relatively-routine instances, such as those in which the adjudication timeframe is impacted by a weekend or holiday. CMS notes that any extensions in Part D should have a shorter maximum timeframe than in Medicare Advantage, which allows for an extension of up to 14 days; however, it remains unclear what length of extension CMS would propose and what impact any such extension may have on patients timely access to appropriate therapies (e.g., if the extension to the adjudication timeframe enabled plans to collect the information needed to adjudicate and approve a prior authorization request, which they may have otherwise rejected outright due to incomplete information). BIO strongly urges CMS to exercise the utmost caution in evaluating any extensions to adjudication time periods in order to ensure there is no undue, adverse impact on beneficiaries timely access to needed services and therapies. 12 Eaddy, M. T., C. L. Cook, K. O Day, S. P. Burch, and C. R. Cantrell How Patient Cost-Sharing Trends Affect Adherence and Outcomes: A Literature Review. Pharmacy & Therapeutics 37(1): Draft 2017 Call Letter at p. 183.

7 Page 7 of 10 Furthermore, BIO continues to urge CMS to ensure that adjudication processes are transparent to beneficiaries and to conduct related data collection to better understand whether, and how, beneficiaries are able to navigate these processes. As patients face the increased use of specialty tiers and utilization management requirements, the role of these adjudication processes in ensuring patients can obtain access to needed therapies is pivotal. This can be especially true for patients who need specialty therapies to treat some of the most complex, chronic conditions: for example, MedPAC found that [s]pecialty drugs face utilization management restrictions in over one-third of plans twice as much as other drugs regardless of whether they are placed by the plan on a specialty tier. They are over five times as likely as other drugs to be subject to prior authorization. 14 Thus, providing patients will all of the relevant information they need to engage in an adjudication process including clear and detailed information on the applicable coverage rule or policy and specific coverage requirements that must be met (such as specific formulary requirements relevant to the requested drug) is critical to facilitating a meaningful adjudication process. We note that data collection will help identify gaps in access and allow for overall improvements in benefits. Consequently, we urge CMS to collect and review data designed to identify the extent to which patients are able to access needed services and therapies without undue delay, and to work with stakeholders to strengthen patient access where necessary. VI. BIO Supports CMS s Efforts to Increase Immunizations and Recommends that CMS Require MA Plans to Deem Contracted Pharmacy Providers as In-Network Providers for Immunizations Provided Consistent with State Scope-of-Practice Laws. As CMS notes in the draft 2017 call letter, despite various public health-related targets, adult immunization rates still remain low. 15 To improve the adult vaccination rates, CMS reiterates the Agency s encouragement to plans to set cost-sharing at $0 for dedicated vaccine tiers. BIO strongly supports CMS s efforts to encourage plans to lessen barriers to access given the general correlation between decreased out-of-pocket costs and a patient s increased ability to access the product. However, we remain concerned about MA and Part D plans policies regarding access to vaccines. Indeed, a recent study found that MA and Part D plans offer less access to no-cost vaccines than private plans under the Affordable Care Act. The study also found that, in 2016, only approximately 12 percent of enrollees in MA- PD plans had access to a set of ten recommended vaccines without out-of-pocket costs. 16 This latest work builds on previous evidence: a 2011 Government Accountability Office (GAO) study found that almost 22 million Part D beneficiaries did not receive the routinely recommended vaccinations covered by Part D. In considering this finding, GAO noted that [a] multitude of factors affect beneficiaries access to routinely recommended Part D-covered vaccinations, particularly the low percentage of physicians and pharmacies that stock the relatively new shingles vaccine. Most physicians do not stock the shingles 14 MedPAC Drugs on Specialty Tiers in Part D: A study conducted by staff from NORC at the University of Chicago and from Georgetown University for the Medicare Payment Advisory Commission. p. 2, available at: 15 See draft 2017 Call Letter, p See Avalere. Medicare Has the Potential to Avoid Preventable Illnesses by Encouraging Broader Coverage for Adult Vaccines (Feb. 18, 2016).

8 Page 8 of 10 vaccine due to factors such as the cost of purchasing a supply and Part D billing challenges. In fact, the Alliance for Aging Research identified similar considerations in its 2015 White Paper that comprehensively identified the barriers to higher vaccination rates among those 65 and older. 17 Thus, based on these persistent concerns, BIO urges CMS to closely investigate these and related figures, and work collaboratively with a diverse group of stakeholders to identify mechanisms to overcome the obstacles patients face in obtaining timely access to vaccinations. As part of this effort, we ask that the Agency continue to actively monitor how many plans are offering this level of coverage to determine if/when there is a need to consider such additional action. BIO would also like to remind CMS of an important immunization-access issue that currently reduces the likelihood of reaching important public health goals. Specifically, several vaccines are administered efficiently and conveniently in community settings by pharmacists and other authorized vaccinators. Such settings increase access to immunizations, especially for adults. In fact, the Department of Health and Services (HHS) has several active programs that encourage pharmacists, public health departments, and other community providers to become access sites for vaccine administration. Vaccines against influenza, pneumonia, and hepatitis B (for high/medium risk populations) are covered under Part B without cost-sharing for the Medicare patient including when administered by pharmacists. Yet pharmacists may not be considered members of a MA plan s provider network for the purpose of administering immunizations even though they are typically authorized to administer vaccines under state law and are contracted as part of an MA plan s pharmacy network to dispense prescription drugs. Since pharmacy immunization administration has become a prevailing community practice in recent years, the exclusion of these providers from plan networks can limit access to firstdollar coverage for these vaccines, increasing out-of-pocket costs and reducing access to vaccines (and thus immunization rates) for beneficiaries. In order to broaden the number and variety of sites that administer immunizations, CMS should require MA plans to deem contracted pharmacy providers as in-network providers for immunizations provided in accordance with state scope-of-practice laws. VII. CMS Should Use the Process for Evaluating Preferred Cost-Sharing Pharmacy Network Issues to Evaluate Specialty Pharmacy Access Issues. BIO appreciates CMS s efforts to increase transparency for Preferred Cost-Sharing Pharmacies (PCSPs) and to work with plans to make sure that beneficiaries in all parts of a plan s geographic area have access to PCSPs, 18 and we are pleased to hear that plans have increased PCSP access in BIO urges CMS to take a similar approach to evaluating whether access to specialty pharmacies is adequate under current plan networks. BIO is 17 Alliance for Aging Research (July 29). Our Best Shot: Expanding Prevention Through Vaccination in Older Adults, available at: 012%2022%2015%20final.pdf. 18 See draft 2017 Call Letter, p. 185.

9 Page 9 of 10 concerned that plans are increasingly limiting the number of specialty pharmacies in their pharmacy networks. Many specialty drugs and in particular, biologicals have unique handling, administration, and pharmacy service costs. For example, virtually all biologicals must be shipped and stored at particular temperatures and many require other special handling and administration procedures, sometimes the result of FDA requirements. Accordingly, biologicals often are distributed through specialty pharmacies and administered under special conditions. Therefore, inadequate inclusion of specialty pharmacies may result in lack of meaningful access to formulary drugs. We urge CMS to take steps to identify where plan network inclusion of specialty pharmacies is not adequate to make formulary therapies available, resulting in patients whose only option is to access a formulary drug on an out-of-network basis, and to ensure that plans include the range of pharmacies necessary to provide beneficiaries with meaningful access to formulary therapies. BIO also asks that CMS require that plan sponsors provide sufficient notice to patients of changes to a plan s specialty pharmacy networks to ensure continuity of access is maintained. VIII. CMS Should Finalize the Removal of the HRM Measure from the Star Ratings. BIO supports CMS s proposal to remove the HRM measure from the Star Ratings and move the measure to the 2017 display page. We agree that avoiding the utilization of potentially inappropriate medications for Medicare patients is an important quality of care metric, but that the HRM measure for Part D beneficiaries addresses this issue only tangentially. Moreover, this measure may be inadvertently applied in a punitive manner, disadvantaging plans that enroll certain types of patients who require therapies on the HRM list. As CMS notes in the draft 2017 Call Letter, therapies on the HRM list are not contraindicated for use in the Medicare population, but instead, placement on the list is meant to denote the need for clinicians to take particular care in weighing the benefits and risks of utilization in this population. The decision to prescribe the therapy should be made based on the clinical circumstances of an individual patient, circumstances not comprehensively described by prescription drug event (PDE) data, on which the HRM measure is based. Thus, even when an HRM-listed therapy is the most clinically appropriate treatment for an individual Medicare beneficiary, this measure may penalize the plan in which the beneficiary is enrolled by negatively impacting its Star Rating. When moved to the display measures, the HRM measure will still be reported to providers on a monthly basis, such that its potential to inform, but not unduly influence, clinical behavior will persist. For these reasons, BIO urges CMS to finalize the proposal to remove the HRM measure from the Star Ratings and move it to the display measures for IX. CMS Should Add Lung Cancer Screening to the Part C Star Ratings Measures. BIO supports efforts to regularly review and update the Part C Star Ratings Measures to ensure that they meaningfully capture information regarding clinical quality, customer satisfaction, and other components of beneficiary experience. The Part C Measures now include Breast Cancer Screening (C01) and Colorectal Cancer Screening (C02) as part of Domain 1 Staying Healthy: Screenings, Tests and Vaccines, with Breast Cancer Screening returning to the Star Ratings as of With respect to Domain 1, BIO believes it is

10 Page 10 of 10 important for CMS to continue to assess the Part C Star Ratings Measures to ensure they reflect the continued introduction of new screenings, tests, and vaccines to support staying healthy. Accordingly, we note with concern the absence of lung cancer screening from the Start Ratings Measures. Given that lung cancer is the third most common cancer among men and women in the U.S., and is the leading cause of cancer-related deaths, BIO believes that Low Dose CT Screening for Lung Cancer should also be included in the Part C Star Ratings Measures, along screenings for breast cancer and colorectal cancer. 19 Low Dose Computed Tomography (CT) Screening for Lung Cancer has been recommended by the U.S. Preventive Services Task Force (USPSTF) and is subject to a CMS-issued National Coverage Decision; consistent with these coverage-related policies of USPSTF and CMS, we urge the Agency to update the Star Ratings Measures to include this important screening. X. Conclusion BIO appreciates the opportunity to comment on this draft 2017 Call Letter. We look forward to continuing to work with CMS on these critical issues in the future. Please feel free to contact me at (202) if you have any questions or if we can be of further assistance. Thank you for your attention to this very important matter. Sincerely, /s/ Laurel L. Todd Vice President Health Care Policy & Research 19 American Cancer Society Cancer Facts & Figures Figure 3, p. 10, available at: