3/21/18 ASCO Update Amanda Schwartz, MPS Director, Congressional Affairs Federal Legislative Issues 1
3/21/18 340B ASCO Recommendations § Greater transparency on use of funds. Require 340B covered entities to account for the amount of 340B savings and the percentage reinvested in caring for uninsured, underinsured and Medicaid populations � § Congress should discontinue DSH as an eligibility criterion for hospitals � § HRSA and Congress should expedite efforts to refine and clarify key program definitions, including “patient” � § HRSA should be given appropriate levels of funding to engage in oversight activities � § Policymakers should place special emphasis on understanding and responding to any adverse impacts that the 340B Drug Pricing program may have on patient access to high-quality oncology care � § Policymakers should consider how recent expansion affects patient access to care at community oncology practices � 2
3/21/18 Administrative, Legal and Legislative Action § OPPS Rule: ASP-22.5% effective January 1, 2018 � § Lawsuit to stop cuts unsuccessful to this point � § Multiple bills introduced to undo cuts, pause enrollment in the program � Energy & Commerce Committee Focus Report Issued on Program in January. Recommended, in part � § Legislation § Congress should give HRSA sufficient regulatory authority expected, likely to and resources to adequately administer and oversee the address many of 340B program. � § Congress should clarify the intent of the 340B program to ASCO’s ensure that HRSA administers and oversees the 340B recommendations � program in a way that is consistent with that intent. � § Congress, or HRSA where HRSA already has authority to make such changes, should promote transparency in the 340B program, including ensuring that covered entities and other relevant stakeholders have access to ceiling prices, and requiring covered entities to disclose information about annual 340B program savings and/or revenue. � § Congress should establish a mechanism to monitor the level of charity care provided by covered entities. � 3
3/21/18 Practice Issues Addressed in Continuing Resolution “Wins” • Drugs out of the MIPS performance based payment adjustment � • Cost measure can stay at a lower weight (10% of performance score) for three years before moving to 30% � • Repeal of the Independent Payment Advisory Board (IPAB) � • Relief from burdensome meaningful use (MU) standards � 4
3/21/18 Opioids Lots of Congressional Activity § 127 individual pieces of legislation introduced � § Weekly hearings happening when in session � § In district events happening when they’re out of session � § “CARA 2.0” legislation likely � 5
3/21/18 ASCO weighing in on… § PDMPs � § Need for interoperability � § Batch checks � § Designees � § Prescription Limits � § Mandatory Provider Education � § Other Issues Impacting Cancer Patient Access � Federal Funding for Research 6
3/21/18 ASCO Supports Sustained Increases in Funding for… • NIH � • NCI � • FDA � § $2 billion increase for NIH promised in CR � Patient Access 7
� � 3/21/18 ASCO Supports Cancer Drug Coverage Parity Act (HR 1409) � § Oral chemotherapy parity – requires plans to provide no less favorable cost sharing for oral cancer drugs as they do IV cancer drugs � Patients Access to Treatment Act (HR 2999) � § Plans cannot impose higher cost sharing requirements for specialty tiered drugs � Prescription Drug Price Transparency Act (HR 1316) � § Calls for pharmacy benefits manager (PBM) transparency standards under the Medicare prescription drug program and Medicare Advantage program � Health Care Reform 8
3/21/18 ASCO’s HCR Principles § Access to affordable and sufficient healthcare coverage regardless of income or health status. Preserve ban on pre-existing condition limitations, elimination of annual and lifetime coverage caps, and guaranteed renewability � § Access to affordable insurance without interruption � § Access to high-quality cancer care delivered by a cancer specialist that provides the full range of services in a timely manner � § Access to prevention and screening services. Preserve the "no copay" access to screening � § Meaningful access to clinical trials regardless of health insurance coverage � § Any value-based reforms designed and implemented in a patient-centered way � § Healthcare reform efforts should engage patients and providers to obtain meaningful input in order to avoid unintended consequences during implementation � Number of Uninsured Rising 9
3/21/18 Current State of Play § Individual mandate repealed � § Further large scale congressional action unlikely � § New Secretary of HHS, Alex Azar � § Administration working on additional reforms � Medicaid 10
3/21/18 Political Environment Extensive Reform Unlikely Extensive Reform Unlikely � But…Smaller Steps?? But…Smaller Steps?? � § President’s campaign § Legislative � promise not to touch § Administrative � Medicare and Medicaid � § Election year dynamics � § Slim Senate majority � 11
3/21/18 Coming Down the Pike? MEDICARE MEDICARE � MEDICAID MEDICAID � § Mandatory demonstrations � § Work and job training requirements � § Part B drug reforms � § Cuts � § Others? � § Others? � Federal Advocacy 12
� 3/21/18 Priority Federal Advocacy Areas for FDA and NIH § Continued Implementation of 21 st Century Cures and Cancer Moonshot � § Right to Try/Expanded Access � § Protection of Human Subjects: Common Rule � (July 2018 Implementation) � § Tobacco Control and Prevention � § Access to Care: � § Clinical Trial Design and Coverage � § Affordable Drugs (including biosimilars) � Right to Try/Expanded Access § 39 states enacted laws � § Federal Right to Try legislation without patient protections and FDA safety and efficacy review � § Federal bill, FDARA, included provisions on clinical trial inclusion and exclusion criteria � § FDA Expanded Access Program Improvements � § Reagan Udall Foundation Expanded Access Navigator Tool for Providers and Patients � 13
� 3/21/18 Common Rule § Final Rule released – January 19, 2017 � § Implementation delayed until July 19, 2018; � § NIH single IRB – implemented � § Other CR Agencies Single IRB – January 2020 � § Most significant changes � § Single IRB Review � § Change in Clinical Trial Definition to add behavioral health outcomes � § Extension of Common Rule to all clinical trials conducted at U.S. institutions receiving federal funding � § New approaches and exemptions to informed consent – IC more streamlined and made public; minimal risk exemptions � § Allows for broad consent for secondary research for identifiable samples � § Elimination of continuing reviews for minimal risk studies (unless FDA- regulated study) � Utilization Management § Preauthorization � § Step therapy � § Specialty tiers � § Restrictive formularies � § Encouraging use of pathways � 14
� 3/21/18 Sustainable Practice Environment § Advocate QOPI to count for MIPS � § Advance ASCO payment model � § Propose pathways as alternative to avert harmful CMS Part B demonstration � Drug Price Highlighted in State of the Union Jan 30 15
3/21/18 Next Steps? § President, Congress promising action: � § Value-based payment highlighted in cancer payment commision � § Medicare negotiation for drug price? � § Re-importation of drugs? � § Performance based pricing? � § Resurfacing Part B demo? � § ASCO position: hold physicians accountable for utilization utilization…not market entry pricing � ASCO State Advocacy in 2018 16
3/21/18 State Legislative Sessions § Majority of states currently in Session � § Most states meet in biennium sessions � § About half allow for carryover legislation � § ASCO is actively tracking priority issues � *Sessions as of 2/15/18; credit: NCSL.com How ASCO Monitors State Legislation § ASCO tracks legislation by issue using tracking software � § Staff identifies bills that ASCO supports, opposes, are important to monitor, or bills to amend or improve � § ASCO often partners with State Affiliates � § Legislative analysis � § Comment letters � § Testimony � § State ACT Network Alerts � § Media, op-eds, tweets � 17
3/21/18 State Advocacy Priority Issues in 2018 § Opioids Opioids � § High volume of activity on opioids measures continues in the states � § Safe Handling of Hazardous Drugs Safe Handling of Hazardous Drugs � § Monitoring for legislative and regulatory proposals with the State Affiliates � § Oral Parity Oral Parity � § Active involvement in Michigan, North Carolina, Tennessee and Idaho campaigns. Seven states remain without laws � Other State Issues Tracked Bills weighed in on in 2017 ASCO is continuing to track other important legislation in the states including: � § Tobacco Control � § Right to Try � § Pathways � § Medicaid � § Prior Authorization � § Step Therapy � Tobacco Issues Right to Try Pathways Other 18
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