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Educating cancer patients Developing a program to meet Helping patients navigate the on diet and exercise to improve the needs of adolescent and young clinical, psychosocial, and financial their overall health | 24 adults with cancer | 32 aspects of cancer care | 42 ONCOLOGY ISSUES This publication is a benefit of membership Association of Community Cancer Centers March | April 2020 Outcomes from a Community-Based Cancer Survivorship Program Association of Community Cancer Centers
ACCC 37th National Oncology Conference STRATEGIES FOR THE CANCER CARE TEAM Elevate your perspective & reach new heights at the leading conference for innovation in care delivery. OCTOBER 14 –16, 2020 Denver, Colorado ACCC-CANCER.ORG/NOC #ACCCNOC
contents Oncology Issues March | April 2020 Vol. 35 | No. 2 24 Supporting Cancer Survivors in Making Healthful Lifestyle Changes by Wendy Demark-Wahnefried, Jennifer R. Bail, Teri Hoenemeyer, Dorothy W. Pekmezi, Maria Pisu, Karina I. Halilova, Michelle Y. Martin, and Laura Q. Rogers 32 The In-Betweeners: A Focus on Young Adults with Cancer 16 by Kristin S. Donahue and Anne Marie Fraley Rainey 42 Guided Patient Support by Jessica Sima, Lora Anderson, Marianna Wolfmeyer, and Jill Benedeck Impact of a Community-Based 56 Improving Care Coordination: A Model for Lung Cancer Cancer Survivorship Program on Quality of Life 68 The Managing Immunotoxicities in a Virtual Space The Fort Worth Program for Virtual Toxicity Team at Community Survivorship uses Johns Hopkins University a personalized assessment and referral process to address unmet 70 The psychosocial needs of cancer Networking for Health survivors. Virtual Toxicity Team by Rachel Funk-Lawler, Heidi Hamann, Laura Howe-Martin, at Jefferson Health Bijal Balasubramanian, Michael S. 72 The Businelle, Jeffrey Kendall, Joanne It Takes a Village M. Sanders, Sarah N. Price, and Virtual Toxicity Team at Keith Argenbright Cleveland Clinic D E PA RTM E N T S 2 From the Editor | Right to Try: Two Years In 12 Tools | Approved drugs, and more 3 President’s Message | The Year of the Biosimilar 14 Spotlight | Portneuf Cancer Center, Pocatello, Idaho 4 Fast Facts | Wellness trends to watch in 2020, and more 74 Action | ACCC Welcomes Its Newest Members, 6 Issues | Policy Round Up and more 8 Compliance | Preparing for E/M Changes to Outpatient Visits in 2021 76 Views | The Hairstylist Melanoma Challenge OI | March–April 2020 | accc-cancer.org 1
FROM THE EDITOR Right to Try: Two Years In ONCOLOGY ISSUES BY JENNIE CREWS, MD, MMM, FACP The Official Journal of the Association of Community Cancer Centers M Editor-In-Chief Jennie R. Crews, MD, MMM, FACP ay 30, Instead of using Right to Try, many 2020, physicians and manufacturers prefer using Executive Director Christian G. Downs, JD, MHA marks the the FDA’s Expanded Access Program, which Medical Director two-year anniversa- was established in 1987 and offers some Leigh Boehmer, PharmD, BCOP ry of the passage of advantages over Right to Try. Expanded Access Managing Editor the federal Right to has similar eligibility requirements but Monique J. Marino Try law. Like the ex- provides patients with broader options by Associate Editors periences in states allowing access to drugs in earlier phases of Barbara Gabriel that have passed development. The program also provides Maddelynne Parker similar legislation, third-party oversight and guidance to Amanda Patton physicians on drug dosing and safety there was consider- EDITORIAL BOARD able debate over the benefits versus harms monitoring. The FDA reports that 99 percent Nadine Barrett, PhD, MA, MS of the applications it receives are approved, Jennifer Bires, LICSW that a national Right to Try law would usher Stephen Cattaneo, MD in. Proponents argued that existing process- usually within a few days. About 20 percent of Linda Corrigan, MHE, RHIT, CTR es for patients seeking non-U.S. Food and these requests come from oncologists, and in Sigrun Hallmeyer, MD Drug Administration (FDA)-approved, poten- June 2019 the FDA launched Project Facilitate Robin Hearne, RN, MS to streamline the Expanded Access Program Sarah Hudson-DiSalle, PharmD, RPh tially life-saving medication were arduous, Jeff Hunnicutt and a more direct approach was needed by providing a single point of contact for Bridget LeGrazie, APN to improve patient outcomes. Opponents oncology requests. Anne Marie F. Rainey worried that this law would threaten patient Thus far, it appears that Right to Try has Bryan Schmalhofer, MBA, RT(R)(T) not substantially benefited patients and is Kelay Trentham, MS, RDN, CSO safety, clinical trial enrollment, and stake- Gretchen Van Dyck holder legal and financial liability. not favored by providers or manufacturers. Since the passage of Right to Try, reality So, who is benefiting from this law? Perhaps ACCC EXECUTIVE COMMITTEE President looks quite different. The law allows patients organizations seeking to monetize this Ali McBride, PharmD, MS, BCOP with a life-threatening illness who have legislation. A clinical research organization President-Elect exhausted approved options or are unable to has emerged with plans to broker Right to Try Randall A. Oyer, MD participate in a clinical trial to receive an access between manufacturers and medical Secretary investigational drug (that has been through organizations by providing patients with Krista Nelson, MSW, LCSW, OSW-C, BCD Phase 1 testing) from a manufacturer by medication and collecting real-world data on Treasurer providing written informed consent to their outcomes. The Access Hope clinical research David Penberthy, MD, MBA treating physician. However, there is no organization (CRO) was founded by an Immediate Past President obligation on the part of the physician to attorney with experience in biotech and Right Thomas A. Gallo, MS, MDA pursue the request, the manufacturer to to Try legislation. Its website cites benefits of ACCC Board of Trustees provide the drug, or the insurance company this business model to patients, providers, Olalekan Ajayi, PharmD, MBA to pay for treatment or treatment-related and sponsors for whom “Right to Try creates Nadine J. Barrett, PhD, MA, MS complications. The law also offers liability heretofore unthinkable flexibility, legal Nina K. Chavez, MBA, FACMPE immunity, and time and cost reductions Amanda Henson, MSHA, MBA, FACHE protections for physicians and manufacturers. Una Hopkins, DNP, RN, FNP-BC Thus, Right to Try truly is a “right to try,” while creating new data”1 and “truly exclusive Jeff Hunnicutt leaving patients with little assurance and control over your data.” 1 The website also Barbara Jensen, RN, BSN, MBA potentially high risk. It is difficult to know for states that Access Hope also will be exploring S. Michelle Shiller, DO, MSPT “patient pay” 1 for services and medications. Lawrence D. Wagman, MD certain how many people have tried to access Wendi Waugh, RT(R)(T), CMD, CTR, BS investigational drugs under this law because Red flag? Perhaps the concerns originally there are no mandated reporting require- raised by opponents to Right to Try are Oncology Issues serves the multidisciplinary specialty of oncology care and cancer ments. News outlets cite two patients who founded after all. program management. have used Right to Try—one with glioblas- Reference toma and one with Lou Gehrig’s disease. It is 1. Access Hope CRO. For Sponsors/CROs. Oncology Issues (ISSN: 1046-3356) is published bimonthly for a total of 6 issues per year by unknown whether either benefited from the Available online at ahcro.com. Last accessed Taylor & Francis Group, LLC, 530 Walnut Street, treatments they accessed. February 18, 2020. Suite 850, Philadelphia, PA 19106, on behalf of the Association of Community Cancer Centers (ACCC), 1801 Research Blvd, Suite 400, Rockville, MD 20850- 3184, USA. US Postmaster: Please send address changes to Oncology Issues, c/o The Sheridan Press, PO Box 465, Hanover, PA 17331. Copyright © 2020 by the Association of Community Cancer Centers. All rights reserved. No part of this publication may be reproduced, stored, transmitted, or disseminated in any form or by any means without prior written permission from the publisher, Taylor & Francis Group, LLC. 2 March–April 2020 | OI
ACCC PRESIDENT’S MESSAGE Coming in Your 2020 The Year of the Biosimilar ONCOLOGY ISSUES BY ALI MCBRIDE, PHARMD, MS, BCOP “Prescribing” Exercise and Nutrition in Cancer Care W Medical Marijuana ith the effective biosimilar implementation vary (Cannabinoid-Derived Products) advent based on the size and resources of the specific of program and can include: for Cancer Patients biologics decades • State and federal legislation Developing a Model of Risk ago, the practice of • Reimbursement and coverage challenges oncology was • Electronic health record processes and Modification for Breast Cancer forever changed. integration issues Using Integrative Oncology Today, the United • Insufficient or ineffective education for States has the healthcare team members and patients Helping Patients Navigate the largest market for • Pharmacy and therapeutics (P&T) Clinical, Psychosocial, and biologics in the integration Financial Aspects of Cancer Care world, accounting for nearly 50 percent of all • Pharmacovigilance processes and an prescription drug expenditures. This class of understanding of biosimilar outcomes, Telemedicine Improves Access drugs also represents the nation’s fastest which have been associated with a lack of to Supportive Group growing pharmaceutical sector. More than 80 knowledge of biosimilars percent of the revenue from biologic therapy • Uncertainty around therapeutic outcomes. Psychotherapy for Young Adults is derived from oncology indications, and this As we move into this new decade, biosimilars with Cancer percentage is expected to increase in coming represent terrific innovation and (as yet) years as the use of these essential drugs Electronic Multidisciplinary unrealized potential for cost savings. Use of expands throughout clinical care. These these therapies may help cancer programs Conference (eMDC): Case trends are not limited to the United States, improve access to care, reduce total health- Planning in the Virtual Space however, as the global biologics market is care expenditures, and meet alternative expected to top $100 billion by 2023.1 payment model goals and requirements. If we Developing and Implementing The Biologics Price Competition and are to realize the full potential of these a Radiation Oncology App to Innovation Act of 2009, which created an therapies, however, integration of biosimilars abbreviated pathway to approval for Improve the Patient Experience is critical and must be achieved through biosimilar agents, was designed to increase interdisciplinary education of the entire Cancer Life reiMagined: The competition with reference biologics to lower cancer team—from physicians and nurses to CaLM Model of Whole-Person prices, increase patient access, and accelerate pharmacy staff to financial navigators and innovation. Anticipated cost savings with the Cancer Care patients and beyond. We can all play a vital introduction of biosimilars in the U.S. market role in the education, advocacy, and safety Implementing Genetic Cancer was estimated to be from $40 billion to $250 needs inherent with this new class of billion over the following 10 years.2 The added Screening and Testing in a anti-cancer therapies. advantages of biosimilar implementation Medically Underserved under alternative payment models, such as References Community the Oncology Care Model and Merit-Based 1. GBI Research. Global immunology market Incentive Payment System are still yet to be to surpass $100 billion by 2023. Available Reducing Revenue Loss and fully realized. online at: gbiresearch.com/media-center/ Patient Financial Toxicity with To date, more than 25 biosimilars have press-releases/global-immunology- been approved by the U.S. Food and Drug market-to-surpass-100-billion-by-2023. Last Pharmacy Pre-Certification and Administration (FDA), including rheumatol- accessed February 18, 2020. Denials Management ogy therapies, oncology supportive care 2. Deloitte. Winning with biosimilars: agents, and therapeutic oncology drugs. The opportunities in global markets. Available Food Security: A Key first biosimilar, filgrastim-sndz, was approved online at: www2.deloitte.com/content/dam/ Component in One Practice’s in 2015, and as of early 2018 more than 60 Deloitte/us/Documents/life-sciences-health- Financial Advocacy Program biosimilars were enrolled in the FDA’s care/us-lshc-biosimilars-whitepaper-final.pdf. biosimilar development program.3 Despite Last accessed February 18, 2020. Researching the Use of Virtual this aggressive approval and development 3. Dolan C. Opportunities and challenges in Reality (VR) in the Oncology landscape, integration of biosimilars into the biosimilar uptake in oncology. Am J Manag U.S. market has been slow. Barriers to Care. 2018;4(11):S237-S243. Infusion Clinic Optimizing Provider Access in the Rural Healthcare Setting by Utilizing a Physician-Advanced Practice Provider Model OI | March–April 2020 3
more online @ accc-cancer.org Trending Now in Cancer Care RESOURCE As the demand for cancer services rises in the U.S., cancer programs continue to rank three factors as top chal- fast Executive lenges to growth: payer reimbursement requirements, the Physician Wellness Leaders Needed move to value-based payments, and uncertainties in drug pricing reform policies. In ACCC’s 2019 survey, the vast majority (88%) of respondents selected improving care coordination as STAT! a top opportunity for cost savings. Other areas identified for cost savings opportunities included: improving symptom management (85%); utilization of lower cost drugs through In a 2019 consensus paper, the implementation of pathways (76%); and reducing variations in care (72%). Read key findings at accc-cancer.org/trends. National Academy of Medicine’s Action Collaborative on Clinician Pursuing Quality Cancer Care for Well-Being and Resilience recommended BLOG Sexual and Gender Minority Patients an executive level physician wellness leader in ALL healthcare delivery These patients are often misrepresented or overlooked in healthcare. Although social acceptance has grown for sexual organizations. Most organizations have no such leader and and gender minority communities, LGBTQ-specific health risks many believe there is a shortage of qualified candidates to draw from. and recommended screenings are not consistently taught to healthcare providers and patients. One way to improve care of Source. NAM. Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being. Available online at nap.edu/catalog/25521 taking-action-against-clinician- this patient population is to promote and collect sexual and burnout-a-systems-approach-to-professional. gender minority information whenever patient demographics are collected, for example adding language that asks patients their preferred name and pronouns to create gender-neutral intake forms. Read more at accc-cancer.org/acccbuzz-SGM. Top 4 Challenges Managers Face • Juggling management of my team with my other The Immunotherapy Patient PODCAST Perspective responsibilities—68% Journalist Mary Elizabeth Williams, one of the first patients • Hitting team goals—14% treated with combination immunotherapy, discusses her experience as an immunotherapy patient and how to bridge • Getting my team to collaborate with one another—11% communication gaps among patients, providers, and research- • Retaining my employees—4% ers. At the ACCC 36th National Oncology Conference, Williams shared that communication boils down to “making sure Source. 2019 State of patients and providers are on the same page. Telling the same One-on-Ones Report. soapboxhq.com/state- stories, because stories are how we make decisions. Communi- of-one-on-ones-report. cation is about empathy and being clear. It’s not optional.” Hear more at accc-cancer.org/podcast. BiomarkerLIVE Resource Library WEBINAR and Lexicon The important role that biomarkers and molecular profiling play in cancer diagnosis and treatment continues to grow, but keeping pace with this rapidly evolving field can be challenging. ACCC’s BiomarkerLIVE program puts a library of resources and a comprehensive glossary of terms at your fingertips, giving you the knowledge and tools to discuss biomarker testing with colleagues and patients. The BiomarkerLIVE Advisory Committee has developed a webinar on how to use these valuable tools, with expert review of the current cancer biomarker landscape and three case examples. Learn any time, anywhere! accc-cancer.org/ biomarker-live-webinar. 4 accc-cancer.org | March–April 2020 | OI
facts 5 Wellness Trends to Watch in 2020 Physicians Give EHRs an “F” Grade In a recent study, the usability of current EHR systems received a grade of “F” by physician users. The same study found a strong relationship between EHR usability and physician burnout. Study authors recommend, “Given the association between EHR usability and physician burnout, improving EHR usability may be an important approach to help reduce healthcare professional burnout.” Source. Melnick ER, et al. The association between perceived electronic health record usability and professional burnout among U.S. physicians. Mayo Clinic Proc. DOI: 10.1016/j. 1. Financial Wellness. With 64% of Americans mayocp.2019.09.024. experiencing stress about money,1 more employers are offering financial wellness programs to educate employees and help improve employee health and productivity. Generational Differences 2. Technology Integration. As wearables and online in Physician Burnout platforms allow users to sync data in real-time, more • 48% of Generation X physicians report burnout, employers will move to mobile platforms for health interac- compared to 39% of Baby Boomer physicians and 38% tions. Allowing employees to connect with their health info via of Millennial physicians. mobile platforms make employer health programs more • 50% of Baby Boomer physicians say that burnout has had accessible to remote employees. a strong and/or severe impact on their lives, compared to 46% 3. Wellness at Work. From company walking groups to of Generation X physicians and 38% of Millennial physicians. onsite fitness facilities, more employers are seeing the • 77% of Millennial physicians say that burnout has impacted benefits of small investments, like standing desks and their relationships, compared to 73% of Generation X physicians healthier food options in breakrooms. and 69% of Baby Boomer physicians. 4. Flexible Work/Life Balance. Advanced technology Source. Medscape National Physician Burnout & Suicide Report 2020. medscape.com/ and an always-on culture means that work isn’t restricted to slideshow/2020-lifestyle-burnout-6012460?faf=1#1. an office or from 9-5. More employers are embracing flexible working hours and remote work in response to Gen Z and Millennials pushing for greater work/life balance. 5. Health Coaching. More employers will add health coaches to their benefits. These coaches can help employees set goals, identify obstacles, and find solutions, creating healthier, more productive workplace cultures. Source. StayWell Shares Top 5 Employer Wellness Trends in 2020. staywell.com. staywell.com/news/top-5-employer-wellness-trends-in-2020. 1 American Psychological Association. Stress in America: Paying With Our Health. apa. org/news/press/releases/stress/2014/stress-report.pdf. OI | March–April 2020 | accc-cancer.org 5
issues Policy Round Up BY CHRISTIAN G. DOWNS, JD, MHA I n this election year, U.S. healthcare policy remains a topic of great interest to ACCC ability to determine coverage of next- is center stage. To help its members keep member programs. Data from the 2019 generation sequencing laboratory tests for current on recent policy issues that may ACCC Trending Now in Cancer Care Survey other inherited cancers. affect their programs and patients, ACCC found that in the next two years, 35 provides a brief update. percent of cancer programs plan to use Importation of Prescription telehealth for delivery of genetic Drugs CY 2021/2022 Medicare As part of the administration’s push to lower counseling (already difficult to access in Advantage and Part D Proposed prescription drug prices, the FDA released a rural areas), 28 percent for symptom Rule proposed rule and draft guidance on drug consults, 28 percent for oral chemother- On Feb. 5, the Centers for Medicare & importation into the United States. The apy adherence and support, 28 percent for Medicaid Services (CMS) released CMS- proposed rule would authorize states, symptom monitoring (e.g., through an 4190-P, which would: wholesalers, or pharmacists to submit app), 24 percent for psychosocial • Require Part D plans to offer real-time proposals to import prescription drugs from counseling, and 22 percent for nutrition drug price comparison tools to beneficia- Canada into the United States. The rule counseling. ries starting Jan. 1, 2022, to allow excludes importation of biologics and consumers to shop for lower-cost Comment deadline on the proposed rule is infused drugs. alternative therapies under their April 6, 2020. The FDA issued draft guidance that prescription drug benefit plan. Together with the Medicare Advantage describes pathways that drug manufacturers • Allow a second, “preferred” specialty tier and Part D proposed rule, CMS released the would use to import prescription drugs in Part D with a lower cost-sharing 2021 Medicare Advantage and Part D (including biologics) into the United States amount. Advance Notice Part II, in which the agency that are FDA approved, manufactured abroad, • Require Part D plans to disclose the solicits comments on potentially developing and originally intended for sale in a foreign measures they use to evaluate pharmacy measures of generic and biosimilar utiliza- country. performance in their network agree- tion in Medicare Part D as part of a plan’s The proposed rule comes after the Dec. 28, ments. This would allow CMS to track and star rating. Comment deadline on Advance 2019, administration release of a notice of report publicly how plans are measuring Notice Part I and Part II proposals was Friday, proposed rulemaking on drug importation and applying pharmacy performance March 6, 2020. and draft guidance. These actions follow the measures. administration’s “Safe Importation Action • Strengthen network adequacy rules for Coverage for Diagnostic Tests Plan,” released in July 2019, which laid out Medicare Advantage plans by codifying Using Next-Generation pathways for importing certain prescription CMS’s existing network adequacy Sequencing drugs into the United States. methodology. The proposed rule has On Jan. 27, 2020, CMS issued a National provisions addressing access to care in Coverage Determination that expands 340B Under Scrutiny rural areas and encouraging use of coverage of U.S. Food and Drug Administra- In early January, the Government Account- telehealth in all areas. For rural areas, the tion (FDA)-approved laboratory diagnostic ability Office (GAO) released a report calling agency proposes to lower the percentage tests that use next-generation sequencing on the Health Resources and Services of beneficiaries required to live within the for patients with germline, or inherited, Administration (HRSA), an agency of the U.S. maximum time and distances standards ovarian or breast cancer. CMS also gave Department of Health and Human Services from 90 percent to 85 percent. Telehealth Medicare Administrative Contractors the (HHS), to improve processes for assuring that 6 accc-cancer.org | March–April 2020 | OI
participating non-governmental hospitals HRSA lacks the authority to determine the • Provide more details and future opportu- meet 340B Drug Pricing Program eligibility adequacy and appropriateness of state nities to comment on the Oncology Care requirements. The GAO report recommends Medicaid policies and procedures to prevent First Model before finalizing the model. that HRSA: duplicate discounts. On Jan. 8, 2020, CMS Read the full letter at accc-cancer.org/ • Implement a process to verify that all issued guidance on “Best Practices for advocacy. non-governmental hospitals have Avoiding 340B Duplicate Discounts in contracts in place, including throughout Medicaid” (medicaid.gov/sites/default/files/ Medicaid Block Grants: Impact Federal-Policy-Guidance/Downloads/ on Cancer Patients hospitals’ audit periods. cib010820.pdf). On Jan. 29, 2020, CMS released guidance that • Amend its contract reviews to include an would permit states to receive a block grant assessment of whether contracts meet statutory requirements. ACCC Response to Center for for adults not otherwise eligible for Medicaid • Provide better guidance on contract Medicare and Medicaid (i.e., adults younger than age 65). Dubbed the Innovation on Oncology Care “Healthy Adult Opportunity,” the agency is reviews. First Model referring to the plan as a demonstration. In HHS agreed with the GAO recommendations ACCC provided comments to the Center for accepting the block grant—capping the except for the recommendation to set up a Medicare and Medicaid Innovation’s (CMMI) state’s federal funding for Medicaid process to verify that all non-governmental request for information on its concept for the beneficiaries—the state would have greater hospitals have contracts in place. HHS says Oncology Care First Model. Though applaud- flexibility in determining benefits’ coverage that HRSA does not have the resources to ing CMMI for making the Oncology Care First and benefit from a less cumbersome process carry out the recommended verification Model voluntary and envisioning a multi- for adding work requirements and other process and that it would over-burden the payer model, ACCC urged CMMI to: restrictions. Oncology stakeholders, along agency. • Make significant changes to the risk with patient advocacy groups, expressed Later in January, the GAO issued a second tracks for purposes of performance-based concerns that transformation of Medicaid 340B report calling on HRSA and CMS to take payment episodes. through block grants could reduce access to care and result in the rationing of services for action to prevent drug manufacturers from • Structure the prospective payment for the most vulnerable patient populations. As paying duplicate discounts under Medicaid care management and certain other with Medicaid work requirements, the and the 340 Drug Pricing Program. In services as a supplemental payment. agency’s legal authority to push this plan response, HHS and 340 participating • Provide more detail on the methodology forward is likely to be the subject of hospitals asserted that HRSA cannot legally for the novel therapy adjustment and litigation. follow the GAO’s request to examine states’ ensure that the final adjustment duplicate discount prevention policies and adequately accounts for the cost of Christian G. Downs, JD, MHA is executive procedures and then act to enforce these if innovative and often life-saving new director, Association of Community Cancer providers do not comply. CMS states that therapies. Centers, Rockville, Md. OI | March–April 2020 | accc-cancer.org 7
compliance Preparing for E/M Changes to Outpatient Visits in 2021 BY TERI BEDARD BA, RT(R)(T), CPC T here is no argument that the At the same time, the American Medical Straightforward Evaluation and Management (E/M) Association (AMA) convened a taskforce • Self-limited. coding guidelines are in need of an dedicated to updating the E/M CPT® codes. • Minimal or no data review and/or update. The Centers for Medicare & Medicaid The AMA came up with guidelines based analyzed. Services (CMS) has not updated E/M solely on medical decision-making (MDM) • Minimal risk from treatment (including guidelines since 1997, with many providers and time, as well as a dedicated prolonged no treatment) or testing. (Most would and coders still following the 1995 guide- services code specific to outpatient E/M consider this effectively as no risk.). lines. The use of electronic health records visits. This meant that history and/or physical exam would no longer be used to Low (EHRs) has prompted requests for updates. determine the billable level. In an about-face, • Stable, uncomplicated, single problem. The ability to copy and paste documentation • Two documents or independent historian. CMS did away with most, but not all, of the from another provider’s visit notes and • Low risk (i.e., very low risk of anything changes finalized in the CY2019 PFS rule and templates, which incorporate full documen- bad), minimal consent/discussion. instead aligned with those established by tation of the Review of Systems and Physical the AMA. The agency’s decision allows for Exam, can result in documentation that is consistency and continuity of coding and Moderate more complex than what took place during billing for all patients across all payers. • Multiple problems or significantly ill. the encounter, creating issues not foreseen Because most commercial and private payers • Count: Three items between documents in 1995 or 1997. follow AMA guidelines when using CPT and independent historian, or interpret or It is not uncommon to see E/M visit notes codes, it made sense for CMS to do the same confer. run pages long and with no clear documen- and not create more work and confusion for • Would typically review with patient/ tation of what is actually new and part of the providers. surrogate, obtain consent and monitor, or patient encounter. Additionally, the ability to At the Resource-Based Relative Value Scale there are complex social factors in pull in statements from elsewhere in the EHR Symposium in Nov. 2019, the AMA provided management. creates an issue with continuity, because updated definitions, time ranges, and MDM criteria for the outpatient E/M codes High these statements may be old or outdated • Very ill. and no longer pertain to the patient’s (99202-99215) that go into effect Jan. 1, • Same concepts as Moderate. current situation, resulting in contradictory 2021. The following is a summary of the • Discussion includes difficult topics or documentation. changes for CY 2021 as we know them now, decisions for the very ill patient that could To solve this, CMS issued sweeping with the expectation that more updates and happen for which physician or other changes to the outpatient visit codes information may come during the CY 2021 qualified healthcare professional will (99201-99215) in the CY 2019 Medicare CMS rulemaking cycle, as well as AMA coding watch or monitor. Physician Fee Schedule (MPFS) Final Rule, updates for the CY 2021 CPT Manual. Beginning Jan. 1, 2021, practitioners will When counting the number and/or CMS-1715-F, which go into effect Jan. 1, complexity of data reviewed and analyzed, select either MDM or time on which to base 2021, including collapsing visit levels from three different categories are part of the their documentation and coding. three individual reimbursed rates to one. MDM: Based on stakeholder feedback that showed MDM Criteria • Tests, documents, orders, or independent that many disagreed with these reimburse- Providers who select MDM for documenta- historian(s)—each unique test, order, or ment changes, the agency convened tion and coding can select from four levels, document is counted to meet a threshold additional stakeholder meetings. using these updated AMA parameters: number. 8 accc-cancer.org | March–April 2020 | OI
• Independent interpretation of tests is not reported separately. • Discussion of management or test interpretation with external physician/ other qualified healthcare professional/ appropriate source (not reported separately). Time-Based Criteria Providers who use the time-based parameter must understand that more is required than just the mention of the total time spent on the date of the encounter. Documentation must include and support all of the work provided to which time was attributed on that date of service by the billing practitioner and may not include ancillary staff time. The AMA stresses that the following items are to be accounted for and/or included when using the time-based option: • Preparing to see the patient (e.g., review of tests) • Obtaining and/or reviewing separately obtained history CPT 99201 will be deleted effective Jan. 1, definition, but more is expected at the time • Performing a medically necessary 2021. of the 2021 MPFS rulemaking cycle. Code appropriate examination and/or GPC1X (the full Healthcare Common evaluation Prolonged Services Code Procedure Coding System code will be • Counseling and educating the patient/ A new prolonged services code will be released by CMS) is defined as visit complex- family/caregiver available Jan. 1, 2021, that is only for use ity inherent to E/M associated with medical • Ordering medications, tests, or with level 5 outpatient visit codes, 99205 care services that serve as the continuing procedures and 99215. Updates will be made to codes focal point for all needed healthcare services • Referring and communicating with other 99358 and 99359 and providers will no and/or with medical care services that are healthcare professionals (when not longer be allowed to bill them in addition to part of ongoing care related to a patient’s reported separately) the new and established outpatient visits. single, serious, or complex chronic condition. • Documenting clinical information in the This new code has not been assigned a full (Add-on code, list separately in addition to electronic or other health record CPT number, but the definition for the new office/outpatient evaluation and manage- • Independently interpreting results (not 99xxx code will be prolonged office or other ment visit, new or established.) reported separately) and communicating outpatient evaluation and management As CY 2021 comes closer, more education results to the patient/family/caregiver service(s) (beyond the total time of the primary procedure that has been selected and information from both the AMA and • Care coordination (not reported using total time), requiring total time with or CMS is needed to help providers adjust to separately). without direct patient contact beyond the these new E/M guidelines. Both organiza- The AMA also notes that practitioners should tions understand the need for the change usual service on the date of the primary make every effort to improve their ability to and are developing resources to assist service; each 15 minutes (list separately in document electronically in the EHR to avoid providers and coders in understanding these addition to codes 99205, 99215 for office or penalizing the patient and payer by charging big changes so that everyone starts off with other outpatient E/M services). a higher level of code billed. their best foot forward in this new E/M Tables 1 and 2, page 10, list the updated Complexity Code landscape. definitions and time-based ranges for these In 2021 CMS is adding a complexity code as new patient visits, 99202-99205, and an add-on to the E/M outpatient codes. This Teri Bedard, BA, RT(R)(T), CPC, is director, established patient visits, 99211-99215. new code is a revision of language finalized Client Services at Coding Strategies, Inc., These will replace the current definitions and in the CY 2019 MPFS final rule. At present not Powder Springs, Ga., and Revenue Cycle, time ranges used in CY 2020. much is known about this code beyond the Inc., Cedar Park, Tex. OI | March–April 2020 | accc-cancer.org 9
Table 1. New Patient Visit Code Updates for 2021 TOTAL TIME IN MINUTES CPT CODE DEFINITION ON DATE OF ENCOUNTER 99201 Deleted for 2021 N/A Office or other outpatient visit for the evaluation and 99202 management of a new patient, which requires a medically appropriate history and/or 15-29 examination and straightforward medical decision-making. Office or other outpatient visit for the evaluation and management of a new patient, 99203 which requires a medically appropriate history and/or examination and low level of 30-44 medical decision-making. Office or other outpatient visit for the evaluation and management of a new patient, 99204 which requires a medically appropriate history and/or examination and moderate 45-59 level of medical decision-making. Office or other outpatient visit for the evaluation and management of a new patient, 99205 which requires a medically appropriate history and/or examination and high level of 60-74 medical decision-making. Table 2. Established Patient Visit Code Updates for 2021 TOTAL TIME IN MINUTES CPT CODE DEFINITION ON DATE OF ENCOUNTER Office or other outpatient visit for the evaluation and management of an estab- No time is part of this code 99211 lished patient, which may not require the presence of a physician or other qualified in 2021 healthcare professional. Usually, the presenting problem(s) are minimal. Office or other outpatient visit for the evaluation and management of an estab- 99212 lished patient, which requires a medically appropriate history and/or examination 10-19 and straightforward medical decision-making. Office or other outpatient visit for the evaluation and management of an estab- 99213 lished patient, which requires a medically appropriate history and/or examination 20-29 and low level of medical decision-making. Office or other outpatient visit for the evaluation and management of an estab- 99214 lished patient, which requires a medically appropriate history and/or examination 30-39 and moderate level of medical decision-making. Office or other outpatient visit for the evaluation and management of an estab- 99215 lished patient, which requires a medically appropriate history and/or examination 40-54 and high level of medical decision-making. 10 accc-cancer.org | March–April 2020 | OI
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tools Approved Drugs (enfortumab vedotin-ejfv) (Astellas seeking approval of belantamab Pharma Inc. and Seattle Genetics, Inc., mafodotin (GSK2857916) for the • On Jan. 9, 2020, the U.S. Food and Drug astellas.com, seattlegenetics.com) for the treatment of patients with relapsed or and Administration (FDA) approved treatment of adult patients with locally refractory multiple myeloma whose prior Ayvakit™ (avapritinib) (Blueprint advanced or metastatic urothelial cancer therapy included an immunomodulatory Medicines, blueprintmedicines.com) for who have previously received a PD-1/L1 agent, a proteasome inhibitor, and an the treatment of adults with unresect- inhibitor and a platinum-containing chemo- anti-CD38 antibody. able or metastatic gastrointestinal therapy before or after surgery or in a stromal tumor harboring a platelet- • AstraZeneca (astrazeneca.com) locally advanced or metastatic setting. derived growth factor receptor alpha exon announced that the FDA has granted 18 mutation, including PDGFRA D842V • On Jan. 23, 2020, the FDA granted orphan drug designations to PD-L1 mutations. accelerated approval to Tazverik™ Imfinzi® (durvalumab) and anti-CTLA4 (tazemetostat) (Epizyme, Inc., epizyme. antibody tremelimumab for liver cancer. • On Dec. 20, 2019, the FDA granted com) for the treatment of adults and accelerated approval to Enhertu® • Kite (kitepharma.com) announced that it pediatric patients aged 16 years and older (fam-trastuzumab deruxtecan-nxki) has submitted a BLA to the FDA for the with metastatic or locally advanced (Daiichi Sankyo, daiichisankyo.com) for investigational chimeric antigen receptor epithelioid sarcoma not eligible for patients with unresectable or metastatic (CAR) T-cell therapy, KTE-X19, for the complete resection. human epidermal growth factor receptor treatment of adult patients with relapsed 2 (HER2)-positive breast cancer who have • On Dec. 16, 2019, the FDA approved or refractory mantle cell lymphoma. received two or more prior anti-HER2- Xtandi® (enzalutamide) (Astellas Pharma • CytoDyn (cytodyn.com) filed for break- based regimens in the metastatic setting. Inc., astellas.com) for patients with through therapy designation for its metastatic castration-sensitive prostate • On Jan. 8, 2020, the FDA approved targeted therapy, leronlimab (PRO 140), cancer. Keytruda® (pembrolizumab) (Merck, as an adjuvant therapy for the treatment of metastatic triple-negative breast merk.com) as a monotherapy for the Drugs in the News treatment of patients with bacillus cancer. Calmette-Guérin unresponsive, high-risk, • The FDA has approved an investigational • Bristol-Myers Squibb (bms.com) non-muscle-invasive bladder cancer with new drug application for a phase 1 trial of submitted a BLA to the FDA for carcinoma in situ with or without ACE1702 (Acepodia, acepodia.com), a Lisocabtagene Maraleucel (liso-cel), papillary tumors, who are ineligible for or targeted cancer therapy created by a its autologous anti-CD19 CAR T‑cell have elected not to undergo cystectomy. proprietary chemical process that directly immunotherapy including individually links anti-tumor antibodies to the surface formulated CD8+ and CD4+ CAR T-cells for • On Dec. 27, 2019, the FDA approved of natural killer cells. It will soon enter Lynparza® (olaparib) (AstraZeneca and the treatment of adult patients with in-human clinical trials in HER2-positive relapsed or refractory large B-cell Merck, astrazeneca.com, merck.com) for solid tumors. lymphoma after at least two prior the maintenance treatment of adult patients with deleterious or suspected • Amgen (amgen.com) and Allergan plc. therapies. deleterious germline BRCA-mutated (allergan.com) announced the submis- • AstraZeneca (astrazeneca.com) and metastatic pancreatic adenocarcinoma sion of a biologics license application Merck (merck.com) announced that a whose disease has not progressed on at (BLA) to the FDA for ABP 798, a biosimilar supplemental new drug application for least 16 weeks of a first-line plati- candidate to Rituxan® (rituximab). Lynparza® (olaparib) in combination with num-based chemotherapy regimen. • GlaxoSmithKline (gsk.com/en-gb) bevacizumab has been accepted and • On Dec. 18, 2019, the FDA granted announced that the FDA has granted granted priority review by the FDA for the accelerated approval to Padcev™ priority review for the company’s BLA maintenance treatment of patients with advanced ovarian cancer who are in 12 accc-cancer.org | March–April 2020 | OI
complete or partial response to first-line patients with relapsed or refractory acute (selinexor) as a new treatment for platinum-based chemotherapy with myeloid leukemia. patients with relapsed or refractory bevacizumab. The FDA has accepted and diffuse large B-cell lymphoma after at • Eli Lilly (lilly.com) announced that the FDA granted priority review to a second least two prior multi-agent therapies granted priority review for an NDA for supplemental new drug application for and who are ineligible for stem cell selpercatinib (LOXO-292) for the Lynparza® (olaparib) for patients with transplantation, including CAR T-cell treatment of patients with advanced RET metastatic castration-resistant prostate therapy. fusion-positive non-small cell lung cancer and deleterious or suspected cancer, RET-mutant medullary thyroid deleterious germline or somatic cancer, and RET fusion-positive thyroid Approved Genetic Tests and homologous recombination repair gene cancer. Assays mutations who have progressed following prior treatment with a new • Roche (roche.com) announced the • Myriad Genetics, Inc. (myriad.com) hormonal agent. submission of a supplemental BLA to the announced that the FDA has approved FDA for Tecentriq® (atezolizumab) in BRACAnalysis CDx® for use as a • MacroGenics, Inc. (macrogenics.com) announced that it has submitted a BLA combination with Avastin® (bevaci- companion diagnostic test by healthcare for margetuximab, an investigational, zumab) (Genentech, gene.com) for the professionals to identify patients with Fc-engineered, monoclonal antibody that treatment of patients with unresectable metastatic pancreatic cancer who have a targets HER2, for the treatment of hepatocellular carcinoma who have not germline BRCA mutation and are patients with metastatic HER2-positive received prior systemic therapy. candidates for treatment with PARP breast cancer in combination with • Kura Oncology, Inc. (kuraoncology.com) inhibitor Lynparza® (olaparib). chemotherapy. announced that the FDA has granted fast • IceCure Medical Ltd. (icecure-medical. • OBI Pharma, Inc. (obipharma.com) track designation to tipifarnib for the com) announced that it received FDA announced that the FDA has granted treatment of patients with HRAS-mutant clearance for expanded indications of orphan drug designation to OBI-999 for head and neck squamous cell carcinomas Cryoablation Technology, a non- the treatment of gastric cancer. after progression on platinum therapy. surgical liquid nitrogen cryoablation • Seattle Genetics, Inc. (seattlegenetics. technology that destroys benign and • Bristol-Myers Squibb (bms.com) announced that the FDA has accepted com) announced that it has submitted an cancerous tumors by freezing. The new and granted priority review to its NDA to the FDA for tucatinib in combina- FDA clearance will enable the company supplemental BLA for Opdivo® tion with trastuzumab and capecitabine to market its solution for the treatment (nivolumab) in combination with for treatment of patients with locally of cancerous and benign tumors of the Yervoy® (ipilimumab) for the first-line advanced unresectable or metastatic kidney; liver; and ear, nose, and throat; treatment of patients with metastatic or HER2-positive breast cancer, including and further neurology indications. recurrent non-small cell lung cancer with patients with brain metastases, who have • Myriad Genetics, Inc. (myriad.com) no epidermal growth factor receptor or received at least three prior HER2-directed announced submission of a supple- anaplastic lymphoma kinase genomic agents separately or in combination in mentary premarket approval applica- tumor aberrations. the neoadjuvant, adjuvant, or metastatic tion to the FDA for its myChoice® CDx setting. • Precigen, Inc. (precigen.com) announced test to help predict outcomes of that the FDA has granted orphan drug • Karyopharm Therapeutics Inc. (karyo- women with first-line platinum- designation to PRGN-3006, an investiga- pharm.com) announced that it has responsive advanced ovarian cancer tional therapy using Precigen’s non-viral submitted an NDA to the FDA seeking treated with PARP inhibitor Zejula® UltraCAR-T™ therapeutic platform for accelerated approval for Xpovio® (niraparib). OI | March–April 2020 | accc-cancer.org 13
spotlight Portneuf Cancer Center Pocatello, Idaho P ortneuf Cancer Center calls Pocatello, clinic is the “hub” of the cancer center and is multidisciplinary breast clinic, which allows Idaho, home. It overlooks the adjacent to the radiation oncology suite. It patients to meet with their medical sprawling valley of the Portneuf River features 10 exam rooms and a laboratory oncologist, radiation oncologist, and surgeon that leads to a beautiful reservoir. Surround- draw station. all in one visit. The nurse navigator is key to ing mountains create panoramic views in Radiation oncology services are located this coordinated planning and responsible for every direction. The cancer center, which opposite to the outpatient clinic and infusion ensuring that any extra testing is scheduled opened in 2004, is located in its own suite. The cancer center boasts an Elekta and completed before the clinic visit. single-story building on the campus of Infinity™ linear accelerator, cone beam Individuals with colon or rectal cancer follow computed tomography scanner, and large a similar patient flow, and the aim with all Portneuf Medical Center and operates as a bore computed tomography scanner. other patients is to meet the cancer center’s hospital outpatient department. The cancer Patients can receive a range of treatments, goal of scheduling a consultation within center treats patients from southeastern including 3D conformal, intensity-modulated three to five days of the initial referral. Idaho and cares for a diverse rural radiation therapy, volumetric-modulated arc The cancer center takes pride in its population. multidisciplinary approach to cancer care therapy, image-guided radiation therapy, stereotactic body radiation therapy, and and the variety of supportive services it Under One Roof stereotactic radiosurgery. The radiation provides patients. (Patients can take Patients at Portneuf Cancer Center do not oncology suite is staffed by three radiation advantage of these services at any point have to travel to separate locations for therapists, one medical dosimetrist, and one during their treatment journey.) All patients care—medical oncology, radiation oncology, medical physicist. meet with the program’s social worker and dietitians, and a social worker all provide care full-time dietitian at the start of their In addition to the infusion suite nurses under the same roof. “The beautiful thing treatment. The dietitian establishes a good and radiation suite, the Portneuf Cancer about this is that when patients walk into Center is staffed by two medical oncologists, nutritional base for patients, who may the cancer center, our staff knows their name two radiation oncologists, three certified schedule follow-up visits, if necessary. and the patients become part of the fabric of physician assistants, one oncology nurse Patients can also self-refer to meet with the our center,” explains Mary Keating, director of navigator, one licensed social worker, three social worker and financial counselors. marketing. financial counselors, one registered dietitian, Portneuf Cancer Center has received the Housed within the cancer center is an and two certified tumor registrars. All of the American Society of Clinical Oncology’s infusion suite, clinic, and radiation suite all center’s medical oncology providers and staff Quality Oncology Practice Initiative on one floor with patient flow in mind. The are hospital employed; radiation oncologists certification. infusion suite, located at the north end of the are contracted. cancer center, includes 10 infusion chairs Outreach Clinics Most patients are referred to the cancer that look out onto the Portneuf Valley Like other healthcare providers serving a center by Portneuf Medical Center’s surgeons through floor-to-ceiling windows and 2 or primary care physicians, which streamlines large rural area, Portneuf Cancer Center’s private infusion rooms with a hospital bed the referral process. The cancer center also delivery of patient-centered care can be and private bedroom. The infusion suite is sees patients referred from outside of the affected by its patients’ geographic location, staffed by 6 nurses—4 full-time, 1 part-time, Pocatello area. ability to travel, and weather conditions. In and 1 as needed (PRN). Three of the nursing The leading cancer sites treated at response to the needs of patients living in staff hold oncology-certified nursing Portneuf Cancer Center include breast, lung, rural settings and to reduce the travel burden credentials and two others have Vascular colorectal, and prostate. Patients with breast for these patients and their families, Portneuf Access Board certification. The outpatient cancer may be seen at the cancer center’s Cancer Center has opened four satellite 14 accc-cancer.org | March–April 2020 | OI
cancer clinics. Farthest from main clinic in hospital runs a free shuttle for travel to the Pocatello is the clinic at Steele Memorial cancer center from either the guest house Hospital in Salmon, Idaho (about 210 miles or RV park; valet service is available for away); the closest satellite clinic is located at those who drive. Caribou Memorial Hospital in Soda Springs, Idaho (about 56 miles away). These clinics are Access to Cutting-Edge staffed daily with licensed practice nurses, a Treatment and Clinical Trials certified medial assistant, and a physician For patients who need treatment beyond assistant. A medical oncologist from Portneuf Cancer Center’s capacity or access Portneuf Cancer Center visits the clinics once to clinical trials, the cancer center a month, spending two days each in Soda facilitates referrals to the Huntsman Cancer thoracic tumor board is attended by Springs and Salmon and a full or half-day at Institute in Salt Lake City, Utah. Portneuf cardiologists, pulmonologists, and cardio- the remaining two satellite sites. Depending Cancer Center has established a streamlined thoracic surgeons. on the clinic location, oncologists will see referral process with the institute and Because the Portneuf Medical Center and between 6 to 20 patients face-to-face. coordination is prioritized by both programs. the cancer center’s staff are a close, tight-knit Chemotherapy, which is overseen by a This referral pathway creates greater group, they are in conversation with one medical oncologist, is available at each clinic. opportunities for Portneuf Cancer Center’s another frequently to discuss patients’ Should a patient need to be seen by the rural patient population, especially those treatment. “They do not hesitate to pick up oncologist other than during a scheduled with more complex or rare diseases, to access the phone to call whichever discipline they visit, the physician assistant or certified specialist care and clinical trials. need to talk to regarding the patient,” medical assistant at the clinic uses telehealth explains Jenni Adams, RN, BSN, OCN, cancer so that patients can be seen by their center director. Therefore, tumor boards are Patient-Centered Care oncology provider. The Portneuf Cancer not the only place in which multidisciplinary Portneuf Cancer Center sees a variety of Center oncologists see about 15 to 20 cancer care is prioritized, because collabora- patients and prioritizes their care in many patients a month via telehealth appoint- tion among clinicians and staff takes place ways. Because it is located next the Fort Hall ments. The cancer center has seen tremen- every day. Reservation, its staff works closely with dous growth in its patient population with Portneuf Cancer Center is proud to have its the Shoshone-Bannock Tribes. A social clinicians and staff working side by side every the implementation of these outreach clinics worker/navigator helps Fort Hall Reservation day. In fact, this close, collaborative environ- because they enable patients to stay in their hometowns with their families. If patients patients navigate and coordinate care with ment may be an advantage of caring for need radiation or combination therapy, they Portneuf Cancer Center. About 10 to 20 patients in its rural setting—the cancer center are treated at the cancer center in Pocatello. percent of the cancer center’s patient has not experienced high turnover rates Patients who must travel to the main facility population travels from Fort Hall. among its nurses, therapists, and/or can take advantage of the resources available There are cultural considerations in providers. “This is a big advantage to at the Portneuf Medical Center to help them treating this specific patient population, and patient-centered care,” explains Robb Dye, with the financial burden of treatment and the center’s staff takes pride in its ability to MSW, licensed clinical social worker. “It is all travel. effectively coordinate and care for these behind the scenes.” This approach has helped patients. To further accommodate its diverse establish crucial relationships among its staff Transportation and Lodging patients, staff members—a medical oncolo- and clinicians that patients experience and gist and social worker—speak fluent Spanish benefit from firsthand. These care providers Support or can help translate for its Spanish-speaking know their patients’ names and stories, and Portneuf Medical Center has a guest house patients, helping to eliminate cultural and patients are greeted by the same smiling face and RV park on its campus to accommodate language barriers to care. at every cancer center visit. visiting patients, their families, and visitors To further its patient-centered focus, who travel long distances or who may Portneuf Cancer Center holds three tumor experience weather disruptions that could boards—a general tumor board, a breast- impact treatment schedules. The RV park has Select supportive care specific tumor board, and a thoracic tumor six paved, full hookup sites available at no services include: board—each scheduled once a month. The cost, situated by picnic tables and majestic • Nutrition services tumor board brings together Portneuf mountain views. Cancer center patients are • Financial counseling services Medical Center’s urologists, surgeons, given priority and can reserve a spot through • Psychosocial services radiologists, interventional radiologist, their nurse navigator or social worker. The • Support groups pathologists, nursing staff, navigators, guest house is located just two miles away medical oncology, radiation oncology, and Approximate number of new analytic from the main hospital, can house two support staff. Its three breast surgeons cases seen in 2019: 400 families, and is also free of charge. The attend the breast tumor board, while the OI | March–April 2020 | accc-cancer.org 15
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