ONCOLOGY ISSUES - Association of Community Cancer Centers

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ONCOLOGY ISSUES - Association of Community Cancer Centers
Creating an oncology practice     Tailoring distress screening to      A curbside clinic offers patients
plan that can change with the     meet the needs of specific patient   another option for accessing
times | 24                        populations | 30                     cancer care | 44

ONCOLOGY
                                                                 ISSUES
This publication is a benefit of membership
Association of Community Cancer Centers

Vol. 36 | No. 5 | 2021

A digital screening tool
connects patients to critical
supportive care services

                                                                                Association of Community Cancer Centers
ONCOLOGY ISSUES - Association of Community Cancer Centers
ACCC 38th

                     STRATEGIES
   NATIONAL
   ONCOLOGY
  CONFERENCE

 INNOVATION TO ACTION
        Austin, TX >>> OCTOBER 20–22, 2021

        Hear actionable “how-to insights” on program operations
        and patient care—LIVE in Austin!
          • Real-world strategies and practical takeaways from the
            2021 ACCC Innovator Award winners
          • Small-group workshops delve into equity and implicit bias,
            supportive care, finding joy at work, and coalition building
          • Peer-to-peer networking, community service activities,
            social events, and more!

                                                            Not sure if you

>>>
                                                             can join us
      REGISTER at accc-cancer.org/NOC to                 in Austin this year?
      save $125. EARLY BIRD RATES EXTENDED!               Stay tuned for details
                                                        on a one-day virtual event
                                                              in November.
ONCOLOGY ISSUES - Association of Community Cancer Centers
contents                                                                          Oncology Issues
                                                                                  Vol. 36 | No. 5 | 2021

24          Creating an Oncology Practice Plan
            That Can Change with the Times
            by James L. Weese, Amy J. Bock, Jacob C. Frick,
            Federico A. Sanchez, Marija Bjegovich-Weidman,
            E. Stuart Arnett, and Corey J. Shamah

30          Tailoring Distress Screening in Oncology
            Populations
            Timing distress screening in
            surgically resectable esophageal cancer

                                                                                  18
            by Laura Melton, Michelle Bunch, Lisa J. Wingrove,
            Megan D. Marsh, Ashley E. Glode, Stephen Leong,
            S. Lindsey Davis, Tracey E. Schefter, Supriya K. Jain,
            Lindel C.K. Dewberry, Karyn Goodman, W. Thomas
            Purcell, and Martin D. McCarter

                                                                                  Demonstrating
36          Mining Data to Improve Care Coordination
            of Patients with Hematologic Malignancies
            by Rachel Dragovich and Jan Kover
                                                                                  Measurable Value:
                                                                                  Distress Screening

44
                                                                                  A digital tool connects
            Cancer Care from the Comfort of Your Car
            Moffitt’s Curbside Clinic gives patients another                      patients to critical
            option for accessing care                                             supportive care services
            by Barbara A. Gabriel, MA                                             Learn how this digital screening tool
                                                                                  is integrated with the EHR, ensuring

52          What Does Leading with Mindfulness                                    that biopsychosocial screening is
            and Compassion Look Like?                                             built into standard of care.
            by Amanda Patton, MA                                                  by Amanda Patton, MA

58          Improving Care Coordination for Advanced
            NSCLC: Results From a National Quality
            Survey for Pathologists and Pulmonologists
            by Michelle Shiller, David J. Feller-Kopman, Nabil Chehab,
            and Leigh M. Boehmer

70          Care Coordination: The Role of Pharmacy to Help Manage Patients with
            Cancer on Oral Oncolytics
D E PA RTM E N T S
       2    From the Editor | A Focus on Our Staff                               14   Tools | Approved drugs, and more

       3    President’s Message | Compassionate Healthcare                       16   Spotlight | Maryland Oncology Hematology

       4    Fast Facts | How is medical debt affecting our finances, and more    75   Action | An update on an ASCO-ACCC joint
                                                                                      initiative, and more
       6    Issues | How Reimbursement Impacts Supportive Cancer Care Services
                                                                                 76   Views | Celebrating Cancer Survivors During
       7    Compliance | Highlights from the CY 2022 MPFS and HOPPS
            Proposed Rules
                                                                                      COVID-19

                                                                                  OI | Vol. 36, No. 5, 2021 | accc-cancer.org  1
ONCOLOGY ISSUES - Association of Community Cancer Centers
FROM THE EDITOR
                                                          A Focus on Our Staff
    ONCOLOGY ISSUES                                       BY SIBEL BLAU, MD
            The Official Journal of the
    Association of Community Cancer Centers

                                                                                      A
                  Editor-In-Chief
                   Sibel Blau, MD                                                                  s we       and allowed staff to get to know each other
                Executive Director
                                                                                                   enter an   better. We instituted weekly departmental
           Christian G. Downs, JD, MHA                                                             era of     manager meetings to increase transparency
              Chief Medical Officer                                                      “rebound” from a     and ensure that all staff receive clear
          Leigh Boehmer, PharmD, BCOP                                                    harsh, bleak year    communication about practice changes. This
                Managing Editor                                                          of COVID-19, most    increased awareness from our management
                Monique J. Marino                                                        of us have mixed     team is translating into staff feeling increased
                Associate Editors                                                        feelings of          appreciation and respect. Our medical
                 Barbara Gabriel                                                         excitement, hope,    director also hosts a monthly town hall. All of
                Maddelynne Parker                                                        fatigue, sadness,    these internal communication efforts help
               EDITORIAL BOARD                                                           and confusion.       our staff to understand and align with our
              Jennifer Bires, LICSW                                                      This amalgam of      organization’s vision and goals.
             Stephen Cattaneo, MD
         Linda Corrigan, MHE, RHIT, CTR                   conflicting emotions is only compounded by              We are looking to bolster resiliency in other
       Sarah Hudson-DiSalle, PharmD, RPh                  economic challenges in every aspect of our          ways as well. For example, even though staff
                  Jeff Hunnicutt                          lives. Moreover, the pandemic and resultant         are extremely busy, we hold intentional
              Bridget LeGrazie, APN
                                                          public health emergency transformed the way         training opportunities aimed at improving
              Anne Marie F. Rainey
         Kelay Trentham, MS, RDN, CSO                     we practice medicine.                               staff confidence on specific topics and
               Gretchen Van Dyck                             As oncologists, we have done our best to         workflows. Other staff take online courses.
      Jenna VanGilder, MHA, RN, OCN, CENP                 care for our patients safely since the onset of         To try to balance work schedules and allow
          ACCC EXECUTIVE COMMITTEE                        COVID-19. This required a huge amount of            more quality time at the office, our staff are
                    President                             time and resources to develop and put into          often cross-trained and encouraged to cover
    Krista Nelson, MSW, LCSW, OSW-C, FAOSW
                                                          practice a wide range of new safety measures.       work for each other. Instituting flexible work
                 President-Elect                          Many oncology practices and cancer                  schedules and remote work opportunities for
           David R. Penberthy, MD, MBA
                                                          programs are now experiencing severe                non-patient-facing positions has also
                     Treasurer
                                                          staffing shortages, placing undue burden on         improved practice morale.
          Nadine J. Barrett, PhD, MA, MS
                                                          existing staff and clinicians. To improve staff         Our management team needs support as
                    Secretary
           Olalekan Ajayi, PharmD, MBA
                                                          retention, teams are being assembled to             well, and our practice provides advance
                                                          tackle issues from mundane technical work           leadership training with a focus on ways to
            Immediate Past President
              Randall A. Oyer, MD                         to strategies for improving employee                support and interact with direct reports.
                                                          satisfaction to processes to create and keep a          Several years ago, our social work team
            ACCC Board of Trustees
               Robert R. Buras, MD                        safe work environment. The question of how          developed a mental health program for
                    Amy Ellis                             to pay for these changes and improvements           patients, and we are now branching this out
Jorge J. García, PharmD, MS, MHA, MBA, FACHE              remains a major issue.                              to include staff. Since the start of the
            Pablo Gutman, MD, MBA
     Amanda Henson, MSHA, MBA, FACHE
                                                             At Northwest Medical Specialties, we, too,       pandemic, social work has sent regular
         Una Hopkins, RN, FNP-BC, DNP                     face challenges from staff stress and               wellness reminders to staff, including
       Ginah Nightingale, PharmD, BCOP                    exhaustion. To address and overcome these           information on mental health awareness. As
                 David Spigel, MD                         challenges, our management team has made            we know, a focus on mental health is key to
     Wendi Waugh, BS, RT(R)(T), CMD, CTR
                                                          it a priority to bolster the resiliency of our      helping our staff and clinicians recover from
                                                          staff. So, what are we doing?                       the stress and heavy workload they have
    Oncology Issues serves the multidisciplinary
                                                             At the start of the public health emergency,     carried for more than a year now.
      specialty of oncology care and cancer               our practice implemented a COVID-19                     If there is a silver lining from this global
              program management.                         Hardship Fund to help staff. Support came           pandemic, it is that the experience shed light
                                                          from paid time off donated by staff and             on the innovation and creativity of the
                                                          financial contributions from managers and           oncology workforce. We all learned ways to
                                                          clinicians. Today this fund is still available to   survive and to pivot into practice transforma-
      Oncology Issues (ISSN: 1046-3356) is published
       bimonthly for a total of 6 issues per year by
                                                          all staff.                                          tion that allowed us to continue providing
     Taylor & Francis Group, LLC, 530 Walnut Street,         With the understanding that communica-           life-saving care to our patients. The cancer
   Suite 850, Philadelphia, PA 19106, on behalf of the    tion is key, we instituted weekly “pod”             community must continue to work together,
   Association of Community Cancer Centers (ACCC),
  1801 Research Blvd, Suite 400, Rockville, MD 20850-     meetings so that team members can openly            share our best practices—what works and
     3184, USA. US Postmaster: Please send address        talk about issues or ask questions—with an          what does not work—and remember to take
   changes to Oncology Issues, c/o The Sheridan Press,    end goal of identifying solutions to those          moments to breathe and engage in mindful-
   PO Box 465, Hanover, PA 17331. Copyright © 2021
  by the Association of Community Cancer Centers. All     problems or answers to those questions.             ness to improve our resiliency and help us
   rights reserved. No part of this publication may be    These meetings improved communication               continue this difficult journey.
reproduced, stored, transmitted, or disseminated in any
form or by any means without prior written permission
     from the publisher, Taylor & Francis Group, LLC.

2       Vol. 36, No. 5, 2021 | OI

ACCC PRESIDENT’S MESSAGE                                                                                  Coming in Your ­2021
Compassionate Healthcare                                                                                  ONCOLOGY ISSUES
BY KRISTA NELSON, MSW, LCSW, OSW-C, FAOSW                                                                     Integrating Spiritual Care in the
                                                                                                              Outpatient Oncology Setting

                           H
                                                                                                              Use of Pharmacy Informatics to
                                      ow do             Between the stimulus and response there is a          Standardize Pharmacist Review
                                      we define         space.
                                                                                                              of Oral Oncolytic Medications
                                      compassion-       In that space is our power to choose our
                             ate healthcare?            response.                                             for Hospitalized Patients
                             Compassion means,          In our response lies our growth and our
                                                                                                              An Investigation of Self-
                             “to suffer together.”      freedom.
                             Compassion is often                                                              Determined Work Motivation
                                                        We can use this space for outward reflection
                             defined as the                                                                   Among Young Adult Central
                                                     and to help us find meaning in suffering. We
                             feeling you get         can also use this space to choose compassion             Nervous System Cancer
                             when you are            for ourselves when we have made a mistake or             Survivors
                             confronted with         when we are experiencing challenges.
                             others’ suffering and      Self-compassion, as defined by Dr. Kristin            Mixed-Method Study Examining
feel motivated to alleviate or lesson that           Neff, an associate professor of Educational              Initial Interactions of Oncology
suffering.                                           Psychology at the University of Texas at Austin          Patients with Multidisciplinary
   In oncology, we often have long-term              and author of the books Self-Compassion: The
relationships with our patients and, therefore,                                                               Cancer Care
                                                     Proven Power of Being Kind to Yourself and Fierce
when their cancer progresses or takes the            Self-Compassion: How Women Can Harness                   A Virtual Integrative Oncology
patient’s life, we experience suffering. This        Kindness to Speak Up, Claim Their Power and
emotion is on top of everything that goes on                                                                  Program Supports Patients
                                                     Thrive, is treating yourself with kindness and
outside the clinic or hospital walls—like a global                                                            with Cancer Throughout the
                                                     understanding, acknowledging your feelings in
pandemic!                                            a non-judgmental way, and recognizing that               Treatment Continuum
   It is the nature of those who work in cancer      everyone struggles sometimes.
care. We sit daily with our patients who are                                                                  Auricular Acupuncture for the
                                                        I’d like to pause here and ask you to reflect
suffering, acknowledging the emotion and then        on a question: How would it be to show the               Treatment of Cancer-Related
trying to alleviate it in some way. Many times,      same compassion for yourself that you show               Pain
being present, allowing the grief, and letting       for the people you care for daily at your cancer
our patients know they aren’t alone is the only      program or practice? And let’s not forget that           Implementation of a Nurse
“treatment” we have.                                 the compassion—and care—we provide                       Practitioner Fellowship Within
   So, what sustains us? How do we do this           encompasses family members and many                      an Academic Medical Center
every day?                                           others who support patients with cancer.
   Oncology Issues recently interviewed Dr. Leigh       Though this concept seems simple, in the              A Model for Integrating APPs in
Weiss, who has taught compassion courses at          context of our current reality—having to do              a Radiation Oncology Satellite
the Stanford School of Medicine, the U.S.            more with fewer resources, a mass exodus of
Department of Veterans Affairs, the Boston                                                                    Clinic
                                                     exhausted and burned-out cancer care team
Center for Refugee Health and Human Rights,          members from the healthcare workforce,                   Spotlight on the Sutter Institute
and the Alzheimer’s Association, among others.       ongoing racial inequity, and, yes, a global
On pages 52-56, Dr. Weiss shares her thoughts                                                                 for Advancing Health Equity
                                                     pandemic—compassion may sometimes be
about a compassionate leadership model that I        too much of a reach.                                     An Oncology Nurse Residency
found thought-                                          But it is a reach worth taking. We must
provoking.                                                                                                    Program Improves Knowledge
                                                     continue to talk about race and what we can              of Delirium in Older Patients
   One point that resonated with me was her          do to improve equity, inclusion, and diversity.
call out to recognize opportunities to work on       We must continue to openly share our distress,           with Cancer
creating more compassionate interactions. To         exhaustion, and other difficult feelings. We
me, this type of mindfulness or attention is                                                                  An APP-Physician Model
                                                     must continue to do the best we can each day.
exactly what Dr. Victor Frankl, an Austrian          But perhaps most importantly, we must                    Improves Risk Stratification and
neurologist, psychiatrist, philosopher, author,      continue to collaborate, listen to each other,           Palliative Care
and Holocaust survivor, is talking about in one      and be understanding of our colleagues so
of his most famous quotes.                           that we can continue to show our patients and
                                                                                                              Remote Monitoring of Patients
                                                     their loved ones the compassion and care our             with Cancer During COVID-19
                                                     field is known for.
                                                                                                              Developing a Cancer Care and
                                                                                                              Community Paramedicine
                                                                                                              Partnership

                                                                                                                   OI | Vol. 36, No. 5, 2021   3
ONCOLOGY ISSUES - Association of Community Cancer Centers
more online @
accc-cancer.org
BLOG
          Cancer Care’s Road to Recovery from
          the Global Pandemic
Debra Patt, MD, PhD, MBA, FASCO, executive vice president, Public
                                                                                                                  fast
Policy and Strategic Initiatives at Texas Oncology, talks to ACCCBuzz
about how delays in cancer screening and treatment during
COVID-19 are translating into cancer mortality. But the news is not
all bad. Dr. Patt shares some silver linings, including how innovative
approaches adopted as a result of the global pandemic have the
potential to reduce disparities in cancer care. Read the full
interview at accc-cancer.org/acccbuzz. Then make plans to attend         Got Trust?
the ACCC 38th National Oncology Conference, Oct. 20-22, in
Austin, Texas, where Dr. Patt will deliver the luncheon keynote.         • Nearly 1 in 3 physicians (30%) say their trust in the U.S.
Register today at accc-cancer.org/NOC.                                       healthcare system and healthcare organization leadership
                                                                             decreased since COVID-19; only 18% report increased trust.
             Billing and Coding Fundamentals
WEBINAR      for Leaders in Oncology                                     • Physicians report high levels of trust for other physicians
This webinar addresses high-level information related to coding              (94% trust doctors within their practice; 85% trust doctors
and billing basics for oncology services. Learn how coding and
                                                                             outside of their practice) and nurses (89%).
billing varies by the setting where the services are performed, the
geographic location of those services, and payer policies. This          • Only 2/3 of physicians (66%) trust healthcare organization
session focuses on common terminology related to coding and
                                                                             leaders and executives.
billing for oncology outpatient services, how these terms apply
to the various care delivery settings, and resources related to          • During the pandemic, physicians report increased trust for
this information. Register and listen today at accc-cancer.org/              fellow physicians (41%) and for nurses (37%).
billing-coding-fundamentals-webinar.
                                                                         • From the patient perspective, older adults (90%), white
              Biomarker Testing Implementation                               people (82%), and high-income individuals (89%) say they
RESOURCE      Roadmap for NSCLC                                              trust their doctors.
This online learning tool helps multidisciplinary cancer care teams
obtain the knowledge they need to implement, expand, and                 • Among people who report lower trust in their doctors, 25%
sustain biomarker testing for patients with advanced NSCLC. The              say their doctor spends too little time with them and 14%
Roadmap offers users information about how to lay the ground-
                                                                             say their doctor does not know or listen to them.
work for biomarker testing, train and prepare their care teams to
offer testing, implement the testing, and evaluate ongoing               • Yet patients trust clinicians—doctors (84%) and nurses
progress. For example, in the Roadmap’s “Lay the Groundwork”                 (85%)—more than the U.S. healthcare system (64%).
section, learn the basics of biomarker testing, assess your
institution’s buy-in, and act by conducting an organizational            • About 1 in 3 patients (32%) say their trust in the healthcare
readiness assessment. accc-cancer.org/nsclc-roadmap.                         system decreased during the pandemic, compared to 11%
                                                                             whose trust increased.
            CANCER BUZZ Podcast Highlights
PODCAST     the Role APs Can Play in Research                            • Nearly all physicians (90%) believe patients can easily
In this episode, Christa Braun-Inglis, MS, APRN, FNP-BC, AONP,               schedule appointments, but nearly 1 in 4 patients
nurse practitioner and clinical researcher at the University of              (24%) disagree.
Hawai‘i Cancer Center in Honolulu, Hawaii, explores how
oncology advanced practitioners (APs) can play a greater role in         • Almost all physicians (98%) say that spending an appropri-
clinical research and, according to a recent national study, have a          ate amount of time with patients is important, but only 77%
strong interest in doing so. Hear how APs can leverage their deep
                                                                             of patients think their doctor spends an appropriate amount
role in day-to-day cancer care decisions to improve diversity in
clinical trials by bringing their experience to trial design and the         of time with them.
accrual process. Find this podcast and two others that share key         Source. Building Trust: An Initiative of the American Board of Internal Medicine
themes and findings from a virtual summit co-hosted by ACCC              Foundation. buildingtrust.org.
and Harborside that helped define the role of APs in equitable
cancer care delivery at accc-cancer.org/podcast.

4  accc-cancer.org | Vol. 36, No. 5, 2021 |      OI
ONCOLOGY ISSUES - Association of Community Cancer Centers
facts                                                                                       One study reported
                                                                                            a 60% reduction
How is Medical Debt
Impacting Our Finances?                                                                     in new oncology trials
                                                                                            globally during the first
• 60% of Americans have been in debt due to medical                                         wave of the COVID-19 pandemic
    bills. 37% owe medical debt, and 23% have had medical
                                                                                            (January 2020 to May 2020).
    debt in the past. On average, these individuals owe
                                                                                            Source. Lamont EB, et al. Trends in oncology clinical trials launched before and during the COVID-19
    between $5K to $10K.                                                                    pandemic. JAMA Netw Open. 2021;4(1):e2036353. doi:10.1001/jamanetworkopen.2020.36353.

• Top drivers of medical debt are often unpredictable,
    unavoidable procedures, like ER visits (39%), doctor or
    specialist visits (28%), surgery (26%), childbirth (22%),
    and dental care (20%).                                                                                                     5 Questions Bosses Ask
• 72% of those who have medical debt said it prevents                                                                          to Cultivate Commitment
    them from achieving key milestones. 34% said it
                                                                                                                                1. When do you feel most proud of
    prevents them from saving for retirement. 1 in 5 (19%)
                                                                                                                                    what you do?
    said it’s preventing them from buying a home, and
    10% said it prevents them from having kids.                                                                                 2. What are the challenges you face
                                                                                                                                    in your work that I don’t see?
• 3 in 4 people who have had medical debt tried to
    negotiate their bill. Nearly all of those who did negotiate                                                                 3. Who on your team have you come
    (93%) had their bill reduced or dropped altogether.                                                                             to count on the most?

Source. Lending Tree. lendingtree.com/personal/medical-debt-survey.                                                             4. What do you need from me that
                                                                                                                                    you aren’t getting?

                                                                                                                                5. If you were to leave this job, what
                                                                                                                                    would be the reason?

                                                                                                                               Source. Joe Mull & Associates. joemull.com. #bossbetter.

Black women are almost 1.5 times more likely
to receive longer breast cancer radiotherapy
regimens than White women, resulting in
increased pain, financial hardship, emotional
stress, and higher mortality.
Source. Emerson MA, et al. Breast cancer treatment delays by socioeconomic and health care access latent
classes in Black and White women. Cancer. 2020;126(22):4957-4966.

                                                                                                                            OI | Vol. 36, No. 5, 2021 | accc-cancer.org   5
ONCOLOGY ISSUES - Association of Community Cancer Centers
issues
How Reimbursement
Impacts Supportive
Cancer Care Services
BY KRISTIN MARIE FERGUSON, DNP, RN, OCN

A
           CCC members across all different            measure to show the value these services         improves patient satisfaction and frees up
           disciplines, including dietitians,          bring to patients—not only to ensure             physicians and APPs to see more patients,
           social workers, pharmacists, nurse          adequate reimbursement but to justify            reducing wait times.
navigators, financial navigators, genetic              increasing full-time employees in key roles,         In terms of achieving health equity, data
counselors, and more, often share with me              like those listed above.                         reflect the need for higher levels of support-
the same phrase, “I’m the only [insert                    Several bills were introduced to Congress     ive care services for historically marginalized
discipline here] in my clinic.” Many times,            this year advocating for reimbursement           patient populations to help reduce—or even
these staff are supporting a large patient             increases for different disciplines and roles,   prevent—negative outcomes, such as
volume in key care coordination and                    including:                                       financial toxicity, malnutrition, and/or
educational areas, such as nutrition, financial        • The Access to Genetic Counselor Services       untreated anxiety or depression.
advocacy, side effect management, and                     Act (H.R. 2144/S.1450)                            In her 2021-2022 ACCC President’s Theme,
genetic counseling.                                    • The Medical Nutrition Therapy Act of 2021      Krista Nelson, MSW, LCSW, OSW-C, FAOSW,
   Being the only staff member providing                  (H.R. 3108/S.1536)                            calls out the need to focus on health equity
certain services in a clinic location brings           • The Improving Access to Mental Health          and social justice, to offer high-reach,
challenges. For example, it limits the                    Act (S.870/H.R. 2035)                         high-impact supportive care services and
individual’s ability to participate in hospital        • The Pharmacy and Medically Underserved         innovative care delivery models that
or practice meetings where these team                     Areas of Enhancement Act (H.R.                demonstrate measurable value, and to
members can share their experiences,                      2759/S.1362).                                 strengthen a culture that supports resiliency
communicate patient needs, and attend                                                                   as an essential for practice. Ensuring that
continuing education events to maintain                Elizabeth Fowler, JD, PhD, director for the
                                                                                                        patients with cancer have access to
their license and update their learning. It can        Center for Medicare & Medicaid Innovation
                                                                                                        high-quality supportive care services and
also have a negative impact on resiliency,             (The Innovation Center), recently commented
                                                                                                        measuring the impact of these services are
morale, and workload. These clinicians worry           that in the push toward a more value-based
                                                                                                        essential to providing high-quality care.
when they take time off for their own                  healthcare system, The Innovation Center is
                                                                                                        Ensuring that supportive care staff have the
medical appointments or vacations. They                considering additional mandatory alternative
                                                                                                        resources and time to reach all patients in
know that they will return to a large volume           payment models. This means that cancer
                                                                                                        need is essential to maintaining a resilient
of patient referrals and an immense amount             programs and practices will need to focus in
                                                                                                        workforce that can provide these high-qual-
of work because no one else could assist               on how quality metrics are created, what
                                                                                                        ity services.
patients in their absence.                             services impact patient outcomes, and how
                                                                                                            Are you a program manager or administra-
   Showing the value and measuring quality             supportive care services can improve these       tor looking to “Make the Case” for hiring
metrics for many supportive cancer care                outcomes. Oftentimes, staffing shortages in      additional supportive care staff? ACCC has
services is challenging. These challenges are          supportive care services increase physician      developed several business case studies to
one of the reasons that many supportive care           and advanced practice provider (APP)             help at: accc-cancer.org/hiring-new-staff. In
services are not reimbursed under our current          workload as these clinicians take on             the next 12 months, ACCC plans to add two
fee-for-service payment methodology. As the            additional tasks, such as completing patient     additional business case studies for oncology
United States healthcare system moves to               paperwork, offering financial assistance, and    social workers and oncology pharmacists.
value-based and bundled payments under                 educating patients about nutrition or genetic
alternative payment models, it is now more             counseling. Having additional, highly trained    Kristin Ferguson, DNP, RN, OCN, is the former
important than ever for cancer programs and            staff members who can effectively deliver on     senior director, Cancer Care Delivery & Health
practices to quantitatively and qualitatively          these types of supportive care services          Policy, Association of Community Cancer
                                                                                                        Centers, Rockville, Md.

6  accc-cancer.org | Vol. 36, No. 5, 2021 |       OI
ONCOLOGY ISSUES - Association of Community Cancer Centers
compliance
Highlights from the CY 2022 MPFS
and HOPPS Proposed Rules
BY TERI BEDARD, BA, RT(R)(T), CPC

O
           ver the past few months there has    values are due to the adjustment of labor          phase-in is done over a four-year transition,
           been a flurry of activity from the   values and the final year of the four-year         similar to when the supply and equipment
           Centers for Medicare & Medicaid      supply and equipment updates. According to         value changes were implemented in CY 2019
Services (CMS), Health and Human Services       CMS, stakeholders requested updated labor          and spread over a four-year timeline.
(HHS), and Health Resources and Services        values to correspond with updated supply           However, CMS is concerned that a phased-in
Administration (HRSA), including the release    and equipment values. Clinical labor rates         transition would result in the need to use
of the CMS calendar year (CY) 2022 proposed     were last updated in CY 2002, and the agency       outdated clinical labor pricing for the time
rules for the Medicare Physician Fee Schedule   is proposing to update the values for CY 2022      the transition is taking place because each
(MPFS) and Hospital Outpatient Prospective      using CY 2019 survey data from the Bureau          year would use partial new values and older
Payment System (HOPPS), extension of the        of Labor and Statistics and other supplemen-       values to calculate payment. CMS estimates
public health emergency by HHS through          tary data when these data are not available.       that the effect of the labor pricing update
Oct. 18, 2021, and HRSA notification of         Note: an increase in labor values is indicated     alone is as follows:
post-payment reporting as part of the           for all of the labor types reviewed by CMS and     • Radiation oncology: −4 percent
Provider Relief Fund (PRF). Below is a          because the values are maintained in a budget-     • Hematology/oncology: −2 percent.
summary of how these notifications may          neutral manner, increases for one specialty or
impact oncology.                                one code (or code set) are possible only           Changes to E/M Services:
                                                because it was taken or adjusted from              Split (or Shared) Visits
MPFS Proposed Changes                                                                              CMS indicated that when the American
                                                another specialty or code (or code set).
On July 13, 2021, CMS issued the proposed                                                          Medical Association adopted new guidelines
                                                    Specifically, for some specialties, like
MPFS rule for CY 2022.1 Comments must be                                                           for outpatient and office setting evaluation
                                                family practice, the labor has a higher-
submitted to CMS by 5:00 PM EST on Sept.                                                           and management (E/M) visits, CMS also
                                                than-average share of the direct costs,
15, 2021.                                                                                          adopted these changes. In the months since
                                                whereas for other specialties, such as
Payment Rates                                   radiation oncology, the labor has a lower-         implementation, the agency indicated a need
For CY 2022, CMS is reversing the 3.75          than-average share of the direct costs.            to clarify or adjust previous guidelines to
percent increase outlined as part of the        Specialties with a higher share of labor costs     align more fully with the updates.
Consolidated Appropriations Act of 2021,        are proposed to receive increased payments            Specific to split (or shared) visits, CMS
which reversed the 10.2 percent cut finalized   for their services, whereas specialties that       indicated that these guidelines do not
to the conversion factor for CY 2022.           have lower direct costs associated to clinical     address:
Removing this and using a conversion factor     labor will see decreases in payment for their      • Who to bill when the visit (and services)
of 33.6319, CMS applied a budget neutrality     services.                                             are performed by different practitioners.
factor of −0.14 percent. This results in a          CMS reviewed the anticipated impact that       • Whether a substantive portion must be
proposed conversion factor of $33.5848,         these labor value changes would have on               performed by the billing practitioner.
which is slightly lower than the conversion     various specialties and the payment for their      • Whether practitioners must be in same
factor for CY 2020.                             services. The agency indicated that when              group.
   Table 1, page 8, outlines the combined       updates to payment methodology result in           • The setting where the split (or shared)
impact of the proposed relative value unit      significant shifts in payments, it does               visits may be furnished to be billed.
(RVU) changes for CY 2022 by specialty. The     consider the possibility and impact of             CMS is proposing to define a split (or shared)
RVU cuts specific to the practice expense       phasing in the changes. Typically, this            visit as an E/M visit performed (split or

                                                                                                 OI | Vol. 36, No. 5, 2021 | accc-cancer.org  7
ONCOLOGY ISSUES - Association of Community Cancer Centers
Table 1. CY 2022 PFS Estimated Impact on Total Allowed Charges by Specialty
                                                                                     (D) IMPACT
                                                           (C) IMPACT OF
                              (B) ALLOWED                                           OF PRACTICE           (E) IMPACT OF MP           (F) COMBINED
    (A) SPECIALTY                                            WORK RVU
                             CHARGES (MIL)                                          EXPENSE RVU             RVU CHANGES                  IMPACT*
                                                             CHANGES
                                                                                      CHANGES

 Hematology/
                           $1,737                       0%                       -2%                      0%                      -2%
 oncology

 Radiation oncology
                       $1,660                           0%                       −5%                      0%                      −5%
 and radiation therapy

The decrease in the conversion factor does result in a decrease in many specialties and their proposed impact; however, CMS has also applied
additional decreases to many of the practice expense values, which reflect a deeper cut to certain specialties, such as interventional radiology,
radiation oncology, vascular surgery, and oral/maxillofacial surgery.
*Column F may not equal the sum of columns C, D, and E due to rounding.

shared) by both a physician and non-                    portion of the visit should be the one to sign    • Documenting clinical information in the
physician practitioner (NPP) who are in the             and date the patient note, but documenta-             electronic or other health record
same group in accordance with applicable                tion should include the names and creden-         • Independently interpreting results (not
laws and regulations. The visit is provided in          tials of both clinicians. Once the total times        separately reported)
a facility setting in which payment for                 between the physician and NPP are added           • Communicating results to the patient,
services furnished incident to is prohibited.                                                                 family, and/or caregiver
                                                        together, the clinician with the majority of
In the non-facility setting, when the                                                                     • Care coordination (not separately
                                                        the time will bill the visit based on the total
physician and NPP each perform compo-                                                                         reported).
                                                        time documented. CMS has also proposed
nents of the visit, it can be billed under the                                                            CMS identified items that would not count
                                                        that prolonged services can be billed in
physician if the incident-to criteria are met.                                                            toward time spent in a visit:
The services are provided in accordance with            addition to the visit when the time-based         • Performance of other services that are
applicable laws and regulations; specifically,          method is used with the total time between            reported separately
either the physician or NPP could bill the              the two clinicians.                               • Travel
payer directly for the visit in the facility               The agency is proposing a list of services     • Teaching that is general and not limited to
setting, rather than bill as a split (or shared)        that would count toward the total time for            discussion that is required for the
visit. CMS is also proposing to allow for split         determining the substantive portion,                  management of a specific patient.
(or shared) visits to be billed for both new            including:                                        CMS is also proposing to create a modifier
and established E/M patient visits.                     • Preparing to see the patient (for example,      for billing purposes to identify a visit as a
    CMS is clarifying that only the physician              review of tests)                               split (or shared) visit. This will allow Medicare
or NPP who performs the substantive                     • Obtaining and/or reviewing separately           to collect data on the frequency and quality
portion of the split (or shared visit) can bill            obtained history                               of visits provided in part by NPPs but paid to
for the visit. CMS is defining “substantive             • Performing a medically appropriate              physicians for the full rate.
portion” to mean more than half of the total                                                                  If the physician and NPP are not in the
                                                           examination and/or evaluation
time spent by the physician or NPP perform-                                                               same group, they would each be expected to
                                                        • Counseling and educating the patient,
ing the visit. Due to the need to determine                                                               bill independently based on the full E/M
                                                           family, and/or caregiver                       criteria for the work provided. If neither
the amount of time spent by each clinician,
CMS is recommending that documentation                  • Ordering medications, tests, or                 practitioner meets the criteria to bill a visit,
of time be included in the patient note, even              procedures                                     modifier 52 for reduced services cannot be
if the medical decision-making method is                • Referring and communicating with other          applied to the E/M visit codes. In this
selected to code the visit. In addition, the               healthcare professionals (when not             scenario, neither professional would be able
clinician who performs the substantive                     separately reported)                           to bill for the visit.

8  accc-cancer.org | Vol. 36, No. 5, 2021 |        OI
ONCOLOGY ISSUES - Association of Community Cancer Centers
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Payment for the Services of Teaching               physician was present can be included.            2.3 percent increase to the outpatient
Physicians                                         Because Medicare already makes payment            department fee schedule.
Stakeholders requested guidance on how             for the program’s share of the resident’s
time spent by residents should be counted          involvement, the agency does not feel that it     Payments of Drugs, Biologicals, and
when selecting the appropriate E/M office          would be appropriate to count the resident        Radiopharmaceuticals
visit level. Section 1842(b) of the Social         time toward the total time. Only the time of      CMS is proposing to continue the payment
Security Act specifies, “In the case of            the teaching physician would count.               policy to pay for drugs purchased under the
physicians’ services furnished to a patient in                                                       340B Drug Program at the average sales price
                                                   HOPPS Proposed Changes
a hospital with a teaching program, the                                                              (ASP) −22.5 percent. The agency is proposing
                                                   On July 19, 2021, CMS issued the proposed
Secretary shall not provide payment for such                                                         to continue to exempt rural sole community
                                                   rules for HOPPS for CY 2022.2 Comments
services unless the physician renders                                                                hospitals, children’s hospitals, and prospec-
                                                   must be submitted to CMS by 5:00 PM EST
sufficient personal and identifiable physi-                                                          tive payment system-exempt cancer
                                                   on Sept. 17, 2021.
cians’ services to the patient to exercise full,                                                     hospitals from this policy.
personal control over the management of            Payment Rates                                        Due to the proposal to use CY 2019 claims
the portion of the case for which payment is       Because of the COVID-19 public health             data for rate setting, CMS is proposing to
sought. Regulations regarding MPFS                 emergency (PHE) and pandemic, CMS is              extend, for up to four quarters, an equitable
payment for teaching physician services.”          proposing to use CY 2019 claims data for rate     adjustment for 27 drugs and biologicals and
   CMS is proposing that when total time is        setting rather than CY 2020 claims date due       one device, which would expire pass-through
used to determine the appropriate E/M office       to the significant impact in utilization of       status at various quarters in CY 2022 and
visit level, only the time the teaching            services. Based on this, CMS is proposing a       extend pricing through the end of CY 2022.

                                                                                                   OI | Vol. 36, No. 5, 2021 | accc-cancer.org  9
The agency is proposing to continue the                 RO Payment Model                                  and varied. Various randomized trials do not
ASP+6 percent payment policy for all drugs,             Below is a summary of the changes CMS is          include radiation therapy as a first-line
biologicals, and therapeutic radiopharma-               proposing to the Radiation Oncology (RO)          therapy. CMS is proposing to only include 15
ceuticals granted pass-through status and               Model. For additional information and             cancer types.
update the list on a quarterly basis.                   resources, visit the RO Model website at:             CMS is also proposing to remove
   CMS is proposing to continue the                     innovation.cms.gov/innovation-models/             brachytherapy services from the list of
packaging threshold for drug administration             radiation-oncology-model. CMS is proposing        included radiation therapy services as part of
at less than or equal to $130; this is the same         a new timeline for the RO Model to extend         the RO Model. This proposal is due to
threshold from CYs 2020 and 2021. CMS is                five years, beginning Jan. 1, 2022, and           stakeholder feedback indicating that
proposing to make drug packaging                        running through Dec. 31, 2026—pending no          because of the bundled payments, there
determination on a drug-specific basis rather           legal or additional congressional interven-       could be decreased utilization where
than on a Healthcare Common Procedure                   tion. The agency also indicated that no new       combined external beam and brachytherapy
Coding System (HCPCS) code-specific basis               episodes of care could begin after Oct. 3,        would be clinically indicated, specifically for
for HCPCS codes that describe the same drug             2026, to allow for treatment completion           cervical and prostate cancers. There is belief
with different dosages.                                 prior to the scheduled end date on Dec. 31,       that the bundling will ultimately result in the
   The agency is proposing to continue the              2016.                                             disincentive to refer patients to another
payment policy for biosimilar biologicals,                  RO Model participants will be selected        radiation oncologist for treatment when the
with pass-through status eligibility made for           using randomly selected core-based                RO Model participant does not or cannot
the biosimilar biological product and not the           statistical areas. CMS is proposing that          deliver brachytherapy services themselves.
reference product. CMS is proposing to                  organizations that are part of the Pennsylva-         CMS is also seeking comments on
continue paying for biosimilar biologicals              nia Rural Health Model will only be excluded      whether intraoperative radiotherapy should
purchased under the 340B Drug Program at                from the RO Model for the time they are           be included in the RO Model. CMS received
ASP−22.5 percent of the biosimilar biological,          participating in the Pennsylvania Model.          stakeholder feedback requesting that this
not the reference product, which is a                   Once a hospital outpatient department is no       service be added. However, because it is only
continuation of the CY 2021 policy.                     longer participating in the Pennsylvania          performed in the hospital setting, it is not
   CMS is proposing to continue to establish            Model and if they are in a selected core-         setting agnostic, and it is limited to certain
payment rates for blood and blood products              based statistical area (or ZIP code), they will   cancer types, CMS has concerns about its
using its blood-specific cost-to-charge ratio           be expected to participate in the RO Model.       inclusion.
methodology, which has been the standard                    CMS is proposing to remove any incentive          Table 2, right, lists the HCPCS codes
since CY 2005.                                          for RO Model participants who change their
                                                                                                          assigned per cancer type as well as the
                                                        taxpayer identification number (TIN) or CMS
                                                                                                          national base rates proposed to begin Jan. 1,
COVID-19 Waivers and Extensions                         certification number (CCN) to become
                                                                                                          2022. Rates are based on a weighted
CMS is seeking comments on several waivers              eligible for the low-volume opt-out. To do
                                                                                                          calculation from three years of claims data
and extensions as part of the COVID-19 PHE.             this, CMS is proposing that an entity would
                                                                                                          prior to the performance year.
Specifically, the agency is looking for                 not be eligible to opt out if its legacy TIN or
                                                                                                              CMS expects the RO Model to meet the
feedback on whether certain provisions,                 legacy CCN was used to bill Medicare for 20
                                                                                                          criteria to be an advanced APM (alternative
which were waived or extended during the                or more episodes or RO episodes, as
                                                                                                          payment model) and merit-based incentive
COVID-19 PHE, should continue for a limited             applicable, of radiation therapy services in
                                                                                                          payment system APM in performance year 1,
period of time or permanently, including:               the two years prior to the corresponding
                                                                                                          beginning Jan. 1, 2022. Final CMS determina-
• Hospital staff furnishing services remotely           performance year in a selected core-based
                                                                                                          tions of advanced APMs and merit-based
   to beneficiaries in their homes through              statistical area. The agency is proposing that
                                                                                                          incentive payment system APMs for the 2022
   use of communications technology.                    it would include episodes and RO episodes
                                                                                                          performance period will be announced via
• Providers furnishing services in which the            associated with a model participant’s
                                                                                                          the Quality Payment Program website at:
   direct supervision requirement for cardiac           current CCN or TIN, as well as any attributed
                                                                                                          qpp.cms.gov/.
   rehabilitation, intensive cardiac rehabilita-        to the participant’s legacy CCN(s) or TIN(s).
   tion, and pulmonary rehabilitation                       CMS is proposing a change to the number       HRSA Provider Relief Fund
   services was met by the supervising                  of cancer types included in the RO Model.         On June 11, 2021, HHS sent a notice to HRSA
   practitioner being available through audio           Initially 16 cancer types were finalized, but     Provider Relief Fund recipients to inform
   and video real-time communications                   after consideration and stakeholder feedback,     them about the data elements they are
   technology.                                          the agency is proposing to remove liver           required to report in the post-payment
• The need for specific coding and payment              diagnosis from these cancer types. CMS            reporting process.3 As part of the Coronavi-
   to remain available under HOPPS for                  indicated that liver cancer and the radiation     rus Aid, Relief, and Economic Security (CARES)
   specimen collection for COVID-19.                    therapy services used to treat it are evolving                            (Continued on page 12)

10  accc-cancer.org | Vol 36, No. 5, 2021 |        OI
Table 2. HCPCS Codes Assigned Per Cancer Type and National Base Rates
           RO MODEL-                                                                INCLUDED
                                      PROFESSION OR TECHNICAL                                                      NATIONAL BASE RATE
         SPECIFIC CODES                                                            CANCER TYPE

 M1072                               Professional                         Anal cancer                         $3,104.11
 M1073                               Technical                            Anal cancer                         $16,800.83
 M1074                               Professional                         Bladder cancer                      $2,787.24
 M1075                               Technical                            Bladder cancer                      $13,556.06
 M1076                               Professional                         Bone metastases                     $1,446.41
 M1077                               Technical                            Bone metastases                     $6,194.22
 M1078                               Professional                         Brain metastases                    $1,651.56
 M1079                               Technical                            Brain metastases                    $9,879.40
 M1080                               Professional                         Breast cancer                       $2,059.59
 M1081                               Technical                            Breast cancer                       $10,001.84
 M1082                               Professional                         CNS tumor                           $2,558.46
 M1083                               Technical                            CNS tumor                           $14,762.37
 M1084                               Professional                         Cervical cancer                     $3,037.12
 M1085                               Technical                            Cervical cancer                     $13,560.15
 M1086                               Professional                         Colorectal cancer                   $2,508.30
 M1087                               Technical                            Colorectal cancer                   $12,200.62
 M1088                               Professional                         Head and neck cancer                $3,107.95
 M1089                               Technical                            Head and neck cancer                $17,497.16
 M1094                               Professional                         Lung cancer                         $2,231.40
 M1095                               Technical                            Lung cancer                         $12,142.39
 M1096                               Professional                         Lymphoma                            $1,724.07
 M1097                               Technical                            Lymphoma                            $7,951.09
 M1098                               Professional                         Pancreatic cancer                   $2,480.83
 M1099                               Technical                            Pancreatic cancer                   $13,636.95
 M1100                               Professional                         Prostate cancer                     $3,378.09
 M1101                               Technical                            Prostate cancer                     $20,415.97
 M1102                               Professional                         Upper GI cancer                     $2,666.79
 M1103                               Technical                            Upper GI cancer                     $14,622.66
 M1104                               Professional                         Uterine cancer                      $2,737.11
 M1105                               Technical                            Uterine cancer                      $14,156.20

National base rates are proposed to begin Jan. 1, 2022; rates are based on a weighted calculation from three years of claims data prior to the
performance year. CNS = central nervous system; GI = gastrointestinal.

                                                                                                OI | Vol. 36, No. 5, 2021 | accc-cancer.org  11
Table 3. Summary of PRF Reporting Requirements
                             PAYMENT RECEIVED PERIOD (PAYMENTS                      DEADLINE TO USE
                                                                                                               REPORTING TIME PERIOD
                           EXCEEDING $10,000 IN AGGREGATE RECEIVED)                     FUNDS

 Period 1                  April 10, 2020-June 30, 2020                            June 30, 2021           July 1, 2021-Sept. 30, 2021
 Period 2                  July 1, 2020-Dec. 31, 2020                              Dec. 31, 2021           Jan. 1, 2022-March 31, 2022
 Period 3                  Jan. 1, 2021-June 30, 2021                              June 30, 2022           July 1, 2022-Sept. 30, 2022
 Period 4                  July 1, 2021-Dec. 31, 2021                              Dec. 31, 2022           Jan. 1, 2023-March 31, 2023

(Continued from page 10)
Act and the Paycheck Protection Program            3. Skilled nursing facility and nursing home     monies were used and that monies were
and Health Care Enhancement Act, monies               infection control distribution payments       used as intended as part of the terms and
were allocated to be distributed to health-           use (if applicable)                           conditions to which the provider agreed
care providers as part of the Provider Relief      4. General and other targeted distribution       when receiving the funds.5 The HHS HRSA
Fund.                                                 payments                                      Provider Relief Fund Portal is active and open
    If determined eligible, qualified providers    5. Net unreimbursed expenses attributable        for reporting at: prfreporting.hrsa.gov/s. If
of healthcare services and support could              to coronavirus                                providers are not already registered, they can
receive relief payments for healthcare-related     6. Lost revenue reimbursement.                   do so at the portal link. Several resources are
expenses for lost revenue due to COVID-19.                                                          available on the portal, which can be
These payments do not need to be paid back,        Healthcare providers who received between        accessed without logging in:
but if recipients received one or more             $10,001 and $499,999 in aggregated relief        • Portal FAQs:
payments exceeding $10,000 in the                  payments during each payment receipt                prfreporting.hrsa.gov/HRSA_FileRender?
aggregate during a payment receipt period,         period are required to report on two                name=PortalFAQs
they must submit reporting requirements as         categories of data: 1) general and adminis-      • Registration User Guide:
agreed to in the terms and conditions of the       trative expenses and 2) healthcare-related          prfreporting.hrsa.gov/HRSA_FileRender?
specific funding.4 Because each distribution       expenses. Those receiving $500,000 or more          name=RegistrationUserGuide
                                                   are required to provide more detail in the       • Reporting User Guide:
has its own terms and conditions, providers
                                                   two categories, including mortgage and rent,        prfreporting.hrsa.gov/HRSA_FileRender?
must review the distribution they received to
                                                   fringe benefits, utilities, supplies and            name=ReportingUserGuide
understand any specifics related to their
                                                   equipment purchased, information                 • Portal Worksheets:
agreement. Table 3, above, outlines the four
                                                   technology, and other healthcare-related            prfreporting.hrsa.gov/HRSA_FileRender?
different periods of payments received, the
                                                   expenses.                                           name=PortalWorksheets.
deadline to use the funds, and the reporting
time period. Healthcare providers must                 The use of the Provider Relief Fund is       As oncology providers continue to work
report how they used the funds received if         specific to costs incurred to prevent, prepare   through 2021, it is not too early to begin
they reach the threshold amount. Reporting         for, and respond to COVID-19. Providers are      preparing for 2022. The many waivers and
is submitted in consolidated reports per the       expected to ensure that documentation is         extensions exercised for the past nearly two
normal basis of accounting. Per the notice,        present and supports how the funds received      years are now coming due in different ways,
data are reported in the following order:          were used. According to the HHS website, the     and it will be interesting to see how all of
1. Interest earned on PRF payment(s)               burden of proof is on the provider to ensure     this will play out as the impact for some may
2. Other assistance received                       that the documentation supports how the          be more burdensome than it is for others.

12  accc-cancer.org | Vol 36, No. 5, 2021 |       OI
Teri Bedard, BA, RT(R)(T), CPC, is executive             Published July 13, 2021. Last accessed July 28,          3. Health and Human Services. Provider Relief Fund
director, Client & Corporate Resources,                  2021.                                                       general and targeted distribution post-payment
                                                                                                                     notice of reporting requirements. Available online
Revenue Cycle Coding Strategies, Cedar Park,          2. Centers for Medicare & Medicaid Services and                at: hhs.gov/sites/default/files/provider-post-pay-
Tex.                                                     Health and Human Services. Medicare program:                ment-notice-of-reporting-require-
                                                         Hospital Outpatient Prospective Payment and                 ments-june-2021.pdf. Published June 11, 2021.
References                                               Ambulatory Surgical Center Payment Systems and              Last accessed June 29, 2021.
1. Centers for Medicare & Medicaid Services and          quality reporting programs; new categories for           4. Health and Human Services. CARES Act Provider
   Health and Human Services. Medicare program;          hospital outpatient department prior authoriza-             Relief Fund: for providers. Available online at: hhs.
   CY 2022 payment policies under the physician fee      tion process; clinical laboratory fee schedule:             gov/coronavirus/cares-act-provider-relief-fund/
   schedule and other changes to Part B payment          laboratory date of service policy; overall hospital         for-providers/index.html#terms-and-conditions.
   policies; Medicare shared savings program             quality star rating methodology; and physi-                 Published June 11, 2021. Last accessed June 29,
   requirements; provider enrollment regulation          cian-owned hospitals. Available online:                     2021.
   updates; provider and supplier prepayment and         federalregister.gov/docu-                                5. Health and Human Services. Provider Relief Fund
   post-payment medical review requirements.             ments/2020/08/12/2020-17086/medicare-pro-                   general information (FAQs). Available online at:
   Available online at: federalregister.gov/             gram-hospital-outpatient-prospective-pay-                   hhs.gov/coronavirus/cares-act-provider-relief-
   public-inspection/2021-14973/medicare-pro-            ment-and-ambulatory-surgical-center-payment.                fund/faqs/provider-relief-fund-general-info/index.
   gram-cy-2022-payment-policies-under-the-physi-        Published July 19, 2021. Last accessed July 29,             html#auditing-reporting-requirements. Last
   cian-fee-schedule-and-other-changes-to-part.          2021.                                                       accessed June 29, 2021.

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                                                                                                               OI | Vol. 36, No. 5, 2021 | accc-cancer.org  13
tools

Approved Drugs                                       •   On July 9, the FDA approved Padcev®              non-Hodgkin’s lymphoma and is outside
                                                         (enfortumab vedotin-ejfv) (Astellas              the FDA accelerated approved indication
•   On June 16, the U.S. Food and Drug                   Pharma, Inc., astellas.com) for adult            for the treatment of adult patients with
    Administration (FDA) approved Ayvakit™               patients with locally advanced or                relapsed follicular lymphoma who have
    (avapritinib) (Blueprint Medicines,                  metastatic urothelial cancer who have            received at least two prior systemic
    blueprintmedicines.com) for adult                    previously received a programmed death           therapies.
    patients with advanced systemic                      receptor 1 or programmed death ligand 1
                                                         inhibitor and platinum-containing            •   Allogene Therapeutics, Inc. (allogene.com)
    mastocytosis (SM), including patients                                                                 announced that the FDA granted fast
    with aggressive SM, SM with an associ-               chemotherapy or patients who are
                                                                                                          track designation to ALLO-605 for the
    ated hematological neoplasm, and mast                ineligible for cisplatin-containing
                                                                                                          treatment of relapsed or refractory
    cell leukemia.                                       chemotherapy and have previously
                                                                                                          multiple myeloma.
                                                         received one or more prior lines of
•   On July 9, the FDA approved Darzalex                 therapy.                                     •   Ascentage Pharma (ascentagepharma.
    Faspro™ (daratumumab and hyaluroni-                                                                   com) announced that the FDA granted an
    dase-fihj) (Janssen Biotech, Inc., janssen.      •   On July 16, the FDA approved Rezurock™
                                                         (belumosudil) (Kadmon Pharmaceuticals,           orphan drug designation to alrizomadlin
    com) in combination with pomalidomide                                                                 (APG-115) for the treatment of stage IIB
    and dexamethasone for adult patients                 LLC, kadmon.com) for adult and pediatric
                                                         patients 12 years and older with chronic         to IV melanoma.
    with multiple myeloma who have received
    at least one prior line of therapy, including        graft-versus-host disease after failure of   •   Agenus Inc. (agenusbio.com) announced
    lenalidomide and a proteasome inhibitor.             at least two prior lines of systemic             that the FDA accepted its biologics license
                                                         therapy.                                         application for balstilimab (AGEN2034)
•   On July 6, the FDA approved an expanded                                                               for the treatment of recurrent or
    label for Keytruda® (pembrolizumab)              •   On July 1, the FDA approved Rylaze™
                                                         (asparaginase erwinia chrysanthemi               metastatic cervical cancer with disease
    (Merck, merck.com) as a monotherapy for                                                               progression on or after chemotherapy.
    the treatment of patients with locally               (recombinant)-rywn) (Jazz
    advanced cutaneous squamous cell                     Pharmaceuticals, jazzpharma.com) as a        •   Exelixis (exelixis.com) announced that the
    carcinoma that is not curable by surgery             component of a chemotherapy regimen              FDA accepted its supplemental NDA for
    or radiation. On July 21, the FDA approved           to treat acute lymphoblastic leukemia            Cabometyx® (cabozantinib) as a
    Keytruda in combination with Lenvima®                and lymphoblastic lymphoma in adult              treatment for patients 12 years and older
    (lenvatinib) (Eisai, us.eisai.com) for               and pediatric patients who are allergic to       with differentiated thyroid cancer who
    patients with advanced endometrial                   the Escherichia coli-derived asparaginase        have progressed following prior therapy
    carcinoma that is not microsatellite                 products commonly used for treatment.            and are radioactive iodine refractory (if
    instability-high or mismatch repair                                                                   radioactive iodine is appropriate).
    deficient, who have disease progression          Drugs in the News
    following prior systemic therapy in any
                                                                                                      •   G1 Therapeutics, Inc. (g1therapeutics.
                                                                                                          com) announced that the FDA granted
    setting, and who are not candidates for          •   Bayer (bayer.com/en/) announced the
                                                                                                          fast track designation to Cosela™
    curative surgery or radiation. On July 26,           submission of a supplemental new drug
                                                                                                          (trilaciclib) for use in combination with
    the FDA approved Keytruda for high-risk,             application (NDA) to the FDA seeking
                                                                                                          chemotherapy for the treatment of locally
    early-stage triple-negative breast cancer            approval of the investigational combina-
                                                                                                          advanced or metastatic triple-negative
    in combination with chemotherapy as                  tion of the anti-cancer treatments
                                                                                                          breast cancer.
    neoadjuvant treatment and then                       Aliqopa® (copanlisib) and rituximab. The
    continued as a single agent as adjuvant              submission is for the treatment of           •   CNS Pharmaceuticals Inc. (cnspharma.
    treatment after surgery.                             patients with relapsed indolent B-cell           com) announced that the FDA granted

14  accc-cancer.org | Vol. 36, No. 5, 2021 |        OI
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