2019 Cancer Care Innovations: Platforms for Information Sharing

By Robert Daly, MD

Robert Daly, MD

Robert Daly, MD

This is the second post in my series on five innovations to look for in 2019 in oncology care delivery. In this piece, I examine the platforms oncologists are using for information sharing. Cancer care has become increasingly complex. Last year the FDA approved 19 applications for new cancer drugs and biologics as well as 38 supplemental indications and four biosimilars. With the increasing pace of discovery in cancer care, clinicians are looking for guidance and expertise into how to integrate these new antineoplastic agents into their practice. In the past, this knowledge sharing was achieved through informal networks and discussions with colleagues. However, ASCO’s State of Cancer Care in America, 2018 finds that most oncology practices remain small with 76% of practices employing only 1-5 oncologists, and there are increasing demands on oncologists’ time with payer and documentation pressures that limit their ability to engage in informal discussions. New platforms have emerged to help foster this knowledge sharing. One such platform is theMednet.org, which has raised over $2.5MM in funding and was co-founded by siblings Nadine Housri, a radiation oncologist at Yale, and Samir Housri, a software engineer. I sat down with Dr. Housri at the ASCO annual meeting to discuss with her how theMednet is serving as a platform for oncologists to ask questions and share expertise about the care of their patients.

The origin story for theMednet came when the Housris’ father was diagnosed with cancer. Nadine reached out to her network and colleagues to find information on the optimal treatment. This experience revealed to her how much medical knowledge is not retrievable and the challenges with unearthing this knowledge, mainly:

  1. The value of knowledge exchanged depends on strength of network.

  2. Valuable experiential knowledge from strong networks are not documented and shared with the community.

theMednet codifies this informal knowledge into a searchable platform to help oncologists answer clinical questions. The questions asked on theMednet are not case-based. In my discussion with Nadine, she emphasized that case based questions help only the physician asking the question but are not beneficial to the greater community. Questions must meet three criteria: 1) there is no clear answer in textbooks, guidelines, or UptoDate; 2) questions must be able to elicit answers that are helpful to the community, and not only the question asker; and, 3) questions must be clinical and have some kind of answer (no “food for thought”). Recent questions on lung cancer include: do you recommend holding a tyrosine kinase inhibitor when treating brain metastases with SRS/WBRT? and How do you approach adjuvant chemotherapy for high grade large cell neuroendocrine lung cancers? There are over 9,600 medical, radiation, and gynecologic oncologists on theMednet with over 700 experts providing answers to these questions. Only physicians are invited to participate to promote a relaxed, empowering environment for clinicians where they can feel comfortable debating controversial issues.  In responding to the questions, theMednet is hoping these clinicians can engage in the type of conversations that used to occur in hospital and clinic hallways. theMednet has adopted many of the practices used by social media sites and the platform is designed to be social where peers are able to agree, comment, share, and vote on the helpfulness of answers.  Nadine reports that experts enjoy participating because it meets their academic mission, it allows them to disseminate their research and have a broader impact, and it helps them to formulate their own thoughts on a topic and learn from their colleagues.  

In speaking with Nadine, she does not feel that theMednet will replace peer-reviewed journal articles as the source of practice changing findings in oncology. Rather the platform will serve to disseminate those findings more broadly. theMednet could, however, influence how journals think about presenting information making findings more digestible to clinicians at the point of care – drilling down to the “so what”, “how does this effect my clinic” of any publication. We have already started to see this effect with shorter more parsimonious abstracts and tweets accompanying academic publications. theMednet has partnered with the American Society of Clinical Oncology on a JCO journal club. The future of how oncologists synthesize and integrate new discoveries may be less through journals and more through digital platforms like theMednet that make those findings relevant to the clinician at the bedside.

theMednet has dreams of the future including expanding beyond oncology to other disease areas. As Nadine indicated there is nothing particular about the model that lends itself exclusively to the field of oncology and they have already branched into gynecologic oncology. The platform also received a grant from NSF to use their platform to match physician search on clinical questions to relevant clinical trials with the goal of increasing awareness of trials in the community. They have also started to build a sustainable business model with sponsored topics and have the backing of Y Combinator and other investors with deep experience in Silicon Valley.  It will be interesting to see how this platform grows between now and ASCO 2020. After all, next year’s theme is “Unite and Conquer: Accelerating Progress Together” and platforms such as theMednet are poised to deliver on that goal of bringing oncology practitioners together.

JOP DAiS encourages discussion and welcomes your comments. Please note that comments are moderated; inappropriate remarks will not be tolerated.

If you have questions for our editors or have a submission inquiry please contact jopcontact@asco.org.  

             

           

           

 

Optimizing Medicaid for Cancer Patients

Federal policy on clinical trial coverage must bring Medicaid up to speed with Medicare, private ACA counterparts

By Steve Lee, MD

Dr. Steve Lee

Dr. Steve Lee

The status of Medicaid remains firmly in the news, with ongoing political and legal questions regarding hot-button issues such as work requirements that have far-reaching implications on access to care. On the oncology front, Medicaid access made waves at the 2019 ASCO Annual Meeting, with an abstract meriting plenary session placement.

The Flatiron Health and Yale study analyzed electronic medical records of over 34,000 patients in the Flatiron database before and after the 2014 expansion of Medicaid via the Obama-era Patient Protection and Affordable Care Act (PPACA).  Most notably, in the post expansion era, African Americans were as likely as their white counterparts to receive first line treatment within 30 days of diagnosis whereas prior to the expansion African Americans were 4.9 percentage points less likely to receive timely treatment. These findings suggest that political decisions which increase access to health coverage can improve the delivery of cancer care, particularly among underserved populations.

I have found this to be true in my former role as an oncologist at Bellevue Hospital Center in New York City. The flagship of New York City's municipal health system, Bellevue receives and treats patients with complex cancer diagnoses regardless of insurance or legal status. Through a unique partnership with New York University as well as its Perlmutter Cancer Center, an NCI-designated Comprehensive Cancer Center, my Bellevue patients had access to a diverse portfolio of clinical trials.

 In other parts of the country, however, Medicaid expansion does not necessarily allow for enrollment and potential benefit from clinical trials.  While Medicare and the vast majority of post-ACA private health insurance plans cover the routine costs of care for patients on clinical trials, these protections do not include Medicaid.  Only twelve states independently cover these charges  which would be incurred regardless of trial status - these include regular appointments, imaging, medications, and hospitalizations; study drugs and study-specific testing are typically covered by the trial sponsor.  Interestingly, New York is not one of these twelve states, and they and 42.2 million Medicaid recipients in the other 37 states may not have access to potentially life-changing clinical trials.

 In response, ASCO has teamed up with other patient advocacy organizations to support H.R. 913, the Clinical Treatment Act. With bipartisan co-sponsors including Rep. Ben Ray Lujan (D-NM) and Rep Gus Bilirakis (R-FL), the bill would bring Medicaid protections up to speed with its Medicare and ACA exchange counterparts. The Flatiron Health and Yale study highlights the promise and potential of reducing disparities through expanded Medicaid while enhancing Medicaid protections in the clinical trial space could lead to greater inclusion in clinical trials and subsequently foster more generalizable research findings.

 While a step in the right direction, H.R. 913 does not promise a solution to all payment-related barriers to clinical trial enrollment. Despite health insurance coverage of medical costs, many patients face onerous out-of-pocket costs such as increased travel expenses and co-pays that restrict the ability to participate in clinical trials. Further, oncologists have found therapy hampered by restrictive prior authorizations and other red tape that can prevent enrollment in a clinically relevant timeframe. In response, ASCO convened a 2017 Roundtable to address the real patient-facing costs of clinical trial research, with policy recommendations. H.R. 913 has not yet received a budget score, though proponents suggest a minimal effect on total health care spending, as routine costs of care are likely to be incurred whether or not a patient is on a trial. After introduction in January 2019, the bill remains in Committee.

JOP DAiS encourages discussion and welcomes your comments. Please note that comments are moderated; inappropriate remarks will not be tolerated.

If you have questions for our editors or have a submission inquiry please contact jopcontact@asco.org.  

 

A Culture of Civility, A Culture of Safety

by Heather Hylton, PA-C

Heather Hylton

Heather Hylton

It is well-established that an array of drivers can lead to professional burnout in healthcare providers.  Tait Shanafelt and John Noseworthy have described seven dimensions into which the drivers can be grouped, including culture and values, control and flexibility, and social support and community at work.  The culture of an organization sets the stage for how individuals of that organization interact and work together.  In addition, organizational culture directly impacts both the work performance of employees as well as the employees’ well-being.  Control and flexibility in healthcare are continuously challenged for a host of reasons including access, productivity pressures, and technology burdens.  Healthcare delivery is contingent upon coordinated work effort from a team, thus underscoring the importance of professionalism, mutual respect, and harmony as essential to the success of the team.

In general, the healthcare environment is highly stressful, making it more vulnerable to disruptive behaviors and incivility within this environment.  Examples of disruptive behaviors and incivility can range from overt actions such as berating or shaming staff in front of patients to more subtle actions such as impatience with or refusing to answer staff questions.  These behaviors can lead to communication problems and patient safety issues as those who are on the receiving end of or who are the target of intimidating behaviors may be reluctant to share information critical to the delivery of safe care to the patient.  This issue has commanded the attention of the Joint Commission who, in July 2008, issued a Sentinel Event Alert (SEA) on the topic of “behaviors that undermine a culture of safety.” Within the SEA, a new leadership standard was announced which requires organizations to have both a code of conduct and a process for managing disruptive and uncivil behaviors.  In addition, the American Medical Association has language specific to disruptive behaviors within its Code of Medical Ethics.

Unfortunately, incivility has been known to beget further incivility, thus compounding the problem.  Microaggressions, which may be subtle, are noted by Narjust Duma and colleagues to “represent enduring institutional and systemic imbalances of privilege and power.”  If unaddressed, microaggressions can insidiously become part of workplace culture. 

In their Toxic Organization Change System model, Elizabeth Holloway and Mitchell Kusy propose organizations implement highly-coordinated strategies at the individual, team, and organizational levels.  Christine Porath notes from her research that 98% of workers she has surveyed over the course of two decades have directly experienced uncivil behavior, and 99% have directly observed uncivil behavior.  While organizations should set standards for behavioral norms, teams can supplement this with their own code of conduct whereby all within the team are accountable to each other.  Christine Porath also offers guidance on how to interview for civility, which is an indispensable part of building a team that embraces the principle of mutual respect.   

Weeding out and addressing behaviors that undermine a civil work environment is not only essential to optimizing patient safety but can also positively impact employee engagement and retention.  Furthermore, a civil and respectful workplace must value inclusivity and seek to mitigate disparities.  Lastly, civility in the workplace can help address burnout in healthcare through enhanced professionalism, collegiality, and cultivating greater support among the team.  

JOP DAiS encourages discussion and welcomes your comments. Please note that comments are moderated; inappropriate remarks will not be tolerated.

If you have questions for our editors or have a submission inquiry please contact jopcontact@asco.org.  

 

Patient-reported Outcomes 2.0

How to optimize the oncology work force to respond to PRO’s

by Bobby Daly, MD, MBA and Abigail Baldwin-Medsker, MSN, RN, OCN

In my blog at the start of this year, I had highlighted five innovations to look for in 2019 in oncology care delivery that hold the promise of positively disrupting the way we practice. One such innovation is the adoption and integration of patient-reported outcomes into oncology clinical care. Basch et al.’s seminal study in 2017 demonstrated that patient reported outcomes achieved improved quality of life, fewer emergency room visits, and a five month gain in overall survival. In discussing the study at the ASCO plenary that year, Dr. Krzyzanowska advocated that active symptom monitoring during chemotherapy should be the new standard of care, but she cautioned that oncology practices must be cognizant of implementation issues in taking up this challenge. A key implementation issue is the workforce redesign that is needed to integrate PRO’s into practice. In writing this blog, we reached out to Dr. Kathi Mooney of the University of Utah, an accomplished researcher in this area to provide insight. 

Dr. Mooney’s work: A Pioneer Pivots in the Provider Responding to PRO’s

Dr. Mooney’s research in this area has explored different models for monitoring patient’s symptoms during ambulatory chemotherapy. In her first study, published in 2014 in the journal Supportive Care in Cancer , medical oncology patients used a touch tone telephone to report 10 common symptoms during chemotherapy. In the intervention group, symptoms exceeding thresholds for moderate-to-severe intensity levels generated emailed alert reports to both the patient’s oncologist and oncology nurse. In the control group patients reported their symptoms daily but understood that the data they submitted were for research purposes only and were not available for clinical action. The overall daily call adherence was 65.0% of expected days and on average 9 moderate-to-severe intensity alerts were generated per patient over the 45 study days. Mooney et al., however, found no significant difference in change of symptom severity between the two groups, and that providers rarely contacted patients after receiving alerts. The authors concluded: “Despite patients’ use of a daily symptom monitoring system and providers’ receipt of unrelieved symptoms of moderate-to-severe intensity, oncology physicians and nurses did not contact patients to intensify symptom treatment nor did symptoms improve.” This led to a pivot in research for a second study published in Cancer Medicine in 2017. In this study, the control group remained the same but in the intervention arm the alerts now went to a dedicated nurse practitioner (NP) for follow-up of poorly controlled symptoms. The NP used a guideline-based decision support system to respond. In contrast to the prior study, this NP-based model (called SymptomCare@Home or SCH) dramatically improved symptom outcomes. With a very rapid treatment benefit, SCH participants had a significant reduction in severe (67% fewer) and moderate (39% fewer) symptom days compared to usual care. We followed up with Dr. Mooney about the lessons learned from these two studies.

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Work Force Models for PRO Monitoring and Management: Research Directions

In summarizing her 2017 study, Dr. Mooney wrote: “We conclude that the efficacy of automated symptom monitoring is dependent on timely oncology provider response to problematic symptoms. Despite the ease and feasibility of remote monitoring, our research suggests that without timely and proper clinical follow-up, telehealth approaches may not improve patient outcomes.” In discussing this finding with us, Dr. Mooney attributed it to provider inertia: providers had competing demands on time and expressed uncertainty about the value of following up on alerts. By creating a dedicated NP team, the SCH model was able to overcome that inertia. She notes though that it is possible to create a model where the primary oncology team manages PRO’s (this was the model Basch et al. employed in a clinical trial setting) but it would require a structure that incentivizes the primary team to respond to alerts and to monitor them as they do other important clinical data, such as labs. Implementing a dedicated team comes with its own challenges, such as fragmentation of care resulting in the oncology team being unaware of the symptom management care being provided. She found that a dedicated team works best when there is a culture of team care for patients. In addition, the NP’s tried to close the communication loop through electronic health record notes and emails to providers. Dr. Mooney also made note that the majority of the interventions implemented by the NP’s were education-based – correcting or reinforcing how patients used supportive medications – and, hence, a dedicated oncology RN model could also potentially support a successful PRO implementation. However, an RN would need ready access to a licensed prescriber for prescriptive issues such as medications or diagnostic tests. She also discovered that the NP’s found a lot of value in the decision support tool as it allowed them to operate autonomously, employ best practices in symptom care, and organize their time to provide more efficient care. Her ongoing clinical trial looks to better delineate the most essential and cost effective elements of the SymptomCare@Home program, including the NP workforce model and the decision support system, so that other institutions will be able to replicate its success.  

ASCO 2019 highlighted many programs that were trying to adapt Basch’s and Mooney’s prior work to their unique clinical environment. Determining the most efficient strategy that best serves our patients, will be of incredible value as we seek to achieve the promise of ASCO 2017 of incorporating PRO’s into the standard of care for oncology patients.

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The Four Pillars of an Ideal Two-sided Risk Value-based Payment Model in Medical Oncology

Aaron J. Lyss, MBA. Director of Strategy and Business Development, Tennessee Oncology, Nashville, TN

Tracy L. Bahl, MBA. President and Chief Executive Officer, OneOncology, Nashville, TN

Jeffrey F. Patton, MD. Chief Executive Officer, Tennessee Oncology; President of Physician Services, OneOncology, both in Nashville, TN

Stephen M. Schleicher, MD, MBA. Medical Oncologist, Tennessee Oncology, Nashville, TN

 

Value-based payment models (VBPMs), which aim to incentivize the highest quality care at the lowest possible cost, have become increasingly prevalent in oncology in recent years among commercial and publicly-funded payers in the US.[1] Several recent federal policy initiatives implemented by the Centers for Medicare and Medicaid Services (CMS) have explicitly aimed to spur the growth of VBPMs, including the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which incentivizes providers to participate in alternative payment models, and the Oncology Care Model (OCM), which is the largest cancer-specific VBPM with 176 medical oncology physician groups (MOPGs) participating in the upside-only (indicates no risk) option.

One challenge CMS has faced with OCM is sufficiently incentivizing MOPGs to voluntarily elect to participate in the two-sided risk option. Under two-sided risk, performance-based payments accrue to MOPGs if they generate greater than 2.5% total Medicare cost savings relative to projected benchmark costs for their attributed patient population, while financial penalties are imposed on MOPGs if total costs are higher than Medicare’s benchmarks. As of today, not a single oncology practice has opted for participation in the OCM two-sided risk option.

Beginning in January of 2020, practices who have not earned performance-based payments will be forced to either exit the model or accept mandatory two-sided risk. Therefore, we found it timely to present a framework to define an ideal two-sided risk model for oncology. Here we describe four fundamental pillars (see Figure 1) of VBPM design that are critical to supporting what we believe are the four primary objectives of VBPMs (higher quality, better access to care, lower costs, better patient experience), and creating value for payers, MOPGS, and most importantly our patients.

Figure 1:  The four pillars of an ideal two-sided risk oncology value-based payment model.

Figure 1: The four pillars of an ideal two-sided risk oncology value-based payment model.

The four fundamental pillars of VBPM design

I.  Aligning control and accountability  

MOPGs should be held accountable for measures of quality that are within their control. There are two subcategories of quality metrics that are especially important to consider in the design and implementation of VBPMs: (1) pathway adherence; and (2) care-coordination related utilization measures.

(1) Appropriate drug utilization should be measured through clinical pathway adherence, not total dollars spent

VBPMs should ensure that patients have access to the most effective therapies for their conditions, and that patients receive treatments that are consistent with their personal goals of care.

MOPGs can control their treatment decisions and should be held accountable for concordance of treatment decisions with clinical pathways. However, MOPGs cannot control the prices of treatments used. Therefore, MOPG accountability for appropriate drug utilization should not be measured by the total dollars spent by payers for patients with cancer, and instead should be measured by clinical pathway adherence provided that the following conditions are met:

 

        1. MOPGs should maintain documentation of physician and patient attestation that treatment decisions were made through a process of shared-decision making. Documentation of the shared-decision making process is critical to ensuring that the treatments patients receive are consistent with their personal goals of care, and that patients are appropriately informed of the risks associated with the treatment they elect to receive.

           

        2. Clinical pathways are updated in real-time based on groundbreaking clinical trial data and FDA approvals, and consider clinical and financial toxicity when appropriate. Pathways should be expert designed and conflicts of interest should be transparent.

           

        3. Physicians should document a reason for any off-pathway treatment decisions.

           

(2) Measured performance outcomes should reflect improved care coordination

Two-sided risk VBPMs should tie MOPG reimbursement to the measurement of outcomes in care-coordination-related utilization categories, since these are metrics that can be influenced (and hence controlled) through the implementation of practice improvement efforts by MPOGs. Studies have shown that the utilization of care-coordination related utilization such as inpatient hospital, emergency department, and inpatient post-acute care services vary widely across MPOGs and represent appropriate measures of high quality, well-coordinated cancer care across a wide variety of tumor types. [ii]

In contrast, reduction in payer drug spending has not been reliably correlated to high quality care, and therefore MOPGs should include distinct compensation thresholds for drug utilization vs.  care-coordination related utilization in two-sided risk VBPMs.[iii], [iv]

II. Accurate benchmarking

At the core of any VBPM is the methodological considerations that create accurate performance benchmarks for participating MOPGs. However, accurate benchmarking in cancer is complicated by the heterogeneity and rising costs of cancer treatments over time.

First of all, due to limitations of claims data, the OCM and many commercial payer VBPMs include drug cost benchmarks that do not consider cancer stage or specific cancer histology. For example, none of the 31 ICD-10 codes for the lung cancer disease grouping of OCM differentiate between non-small cell lung cancer and small cell lung cancer.

However, these distinctions, as well as tumor stage and biomarkers, are critical to determining optimal treatment strategies and expected disease complications that influence reliable benchmarks.[v] For example, the treatment and prognosis of non-small cell lung cancer (which may include surgery) and small cell lung cancer (which often includes prophylactic brain radiation) can vary widely. In contrast, medical oncology clinical pathway development is based on the most important clinical characteristics that drive treatment decisions.

Secondly, accounting for increases in regimen costs due to FDA approvals that occur after baseline periods further complicates the accuracy of benchmarking drug costs. For example, the recent approval of atezolizumab in combination with Nab-paclitaxel in metastatic triple negative breast cancer increased the cost (based on January 2019 average sales price) of the first-line standard-of-care triple negative breast cancer regimen by more than 250-fold compared to the previous standard-of-care treatment single agent weekly paclitaxel.

Therefore, benchmarking MOPGs according to pathway adherence (assuming pathways are updated in realtime based on groundbreaking clinical trial data and FDA approvals) instead of total drug spend may minimize the adverse impact of rising drug prices on the ability for MOPGs to meet benchmarks.

 

III. Bilateralism

When MOPGs participate in VBPMs in which accountability and control are aligned, the next step is determining the equitable compensation for value creation and appropriate financial incentive for taking on risk.  

OCM will offer an interesting case study on bilateralism in the coming years. Last fall OCM participants were faced with the decision of whether to enter the two-sided risk option of OCM or remain in the upside-only option. Using prior performance period data and the newly proposed OCM two-sided risk option specifications, we conducted financial modeling that projected that the maximum possible downside of the two-sided risk option would be approximately 41x the most likely revenue increase (i.e. upside) associated with our two-sided risk participation (see Table 1).

Table 1:  Downside multiplier change based on different model choices.

Table 1: Downside multiplier change based on different model choices.

Therefore, the risk premium (the most probable increase in revenue from entering two-sided risk) was deemed minimal compared to the magnitude of possible losses, which offers a likely explanation for why OCM participants have been reluctant to enter two-sided risk in its current form.

However, in January 2020 OCM participants will be faced with a different decision: to enter two-sided risk or exit the OCM program altogether. When comparing these two options, the maximum possible downside of entering the two-sided risk would be only 5x the risk premium. This improved downside multiplier (maximum downside divided by risk premium) results from the loss of MEOS revenue for MOPGs that exit the OCM model. In effect, MEOS payments become part of the risk premium for the two-sided risk model (since the only alternative is to exit OCM altogether at that point). This dramatic increase in risk premium will likely increase the number of OCM participants who opt to participate in two-sided risk; however, it is unclear whether this increased risk premium will be sufficient to prevent high-quality, low-cost MOPGs from exiting the model in order to avoid higher levels of risk.

 

IV. Scalability

Nationwide proliferation of VBPMs requires that VBPMs be operationally scalable for payers who manage these programs. For example, the permeation of bundled payments in oncology has been partially hampered by challenges with scaling claims processing.[vi] In addition, MOPGs and payers alike have not yet benefited from technology-enabled pathway adherence and clinical data reporting capabilities that are scalable for either party.

To address the remarkable complexity of medical oncology, payers must work closely with thought leaders who are currently engaging in oncology VPBMs to learn from successes and challenges of current VBPM experiments and to make these insights publicly available. This transparency would catalyze an evidence-based approach to VBPM design and implementation, and prevent nationwide expansion of sub-optimized payment models that fail to engage providers and improve the value of care for our patients.

 

Concluding remarks:

The current economics of cancer care in the US are placing an unsustainable strain on our healthcare system. At the same time, payer pressures were cited as the top concern among oncologists in the most recent “State of oncology practice in America, 2018” survey results.[vii] We hope that appropriate VBPM design that incorporates the four pillars described above will mitigate these challenges to our current system of cancer care and lead to higher quality, lower costs, improved access, and better patient experience for our patients.


REFERENCES:

 

[1] Aviki E, Schleicher SM, Mullangi S, et al. Value-based healthcare delivery models in oncology: A systematic review. Cancer 124(16): 3293-3306, 2018.  

[ii] Clough JD, Patel K, Riley GF, et al. Wide variation in payments for Medicare beneficiary oncology services suggests room for practice-level improvement. Health Aff (Millwood) 34(4): 601-608, 2015.

[iii] Newcomer et al. Changing Physician Incentives for Affordable, Quality Cancer Care: Results of an Episode Payment Model. J Oncol Pract 10(5): 322-326, 2014.

[iv] Schleicher SM, Bach PB, Matsoukas K, Korenstein D. Medication overuse in oncology: current trends and future implications for patients and society. Lancet Oncol 19(4): 200-208, 2018.  

[v] Zon RT, Edge SB, Page RD, et al: American Society of Clinical Oncology criteria for high-quality clinical pathways in oncology. J Oncol Pract 13: 207-210, 2017.

[vi] Spinks T, Guzman A, Beadle BM, et al. Development and feasibility of bundled payments for the multidisciplinary treatment of head and neck cancer: A pilot progam. J Oncol Pract 14(2): 103-112, 2018.

[vii] Kirkwood MK, Hanley A, Bruinooge SS, et al: The state of oncology practice in America, 2018: Results of the American Society of Clinical Oncology Practice Census Survey. J Oncol Pract 14(7): 412-420, 2018.

 

The SUPPORT for Patients and Communities Act: A Partial Response Against the Opioid Epidemic

2018 Bipartisan Opioid Package Offers Mostly Indirect Effects on Patients With Cancer

By Steve Lee, MD

In a rare act of bipartisanship, the 115th Congress overwhelmingly adopted The Substance Use- Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which was subsequently signed into law by President Donald Trump on October 24, 2018.  This legislation was welcomed in the context of the alarming increase in opioid harms in the United States, reaching 72,000 deaths in 2017.

While broadly covering topics from increasing the availability of addiction specialists to securing insurance coverage for patients with opioid abuse to encouraging research into non-addictive alternatives for pain, a consensus among analysts is that while the legislative achievement is laudable, the SUPPORT Act ultimately fails to deliver a comprehensive response against the nation's opioid crisis.  Specifically, the bill does not allocate game-changing new funding in the manner employed against the HIV/AIDS epidemic in the 1990s.

And what about cancer patients, whose legitimate needs for potentially high levels of pain control often become collateral damage in wider efforts to curb opioid abuse?  In the past, cancer advocates such as ASCO have identified concerns related to interventions including intentionally difficult prior authorizations, prescribing caps, supply limits, and prescriber punishment as factors that can prevent cancer patients from getting the pain treatment they need. And this is in the context of overreaching contemporary Centers for Disease Control (CDC) opioid guidelines, at least in the opinion of 300+ clinicians in a recently submitted letter.

Fortunately (or unfortunately), the limited reach of the SUPPORT Act against the opioid crisis as a whole limits its harms to cancer patients.  Text of the statute as well as in summary are available.  (Section numbers in parentheses)

The SUPPORT Act calls for a Centers for Medicare & Medicaid Services (CMS) demonstration project in five to ten states which would provide an enhanced federal match for state Medicaid expenditures for substance use disorder (SUD) and recovery (1003).  Nationally, it expands Medicaid access to at-risk populations including post-incarceration juveniles and foster youths (1001) and pregnant/postpartum mothers (1002), and gives states the option for short-term coverage of adults who may have previously been ineligible due to care in Institutions for Mental Diseases (IMD) (5052).  Further, it enforces payment parity in state Children's Health Insurance Programs (CHIP) for SUDs as compared to treatment of physical disease (5022).

To increase access to SUD specialists, the law temporarily widens the pool of medication-assisted therapy (MAT) providers to include waiver-granted clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists, who can treat 100 patients each; physicians can treat 275 patients each (3201).  MAT-training grants are authorized, but not specifically funded (3203).  Individual and system-based efforts to incentivize participation include a six-year loan repayment program for SUD clinicians in high-need areas (7071) as well as grants to Federally Qualified Health Centers (FQHC) and Rural Health Clinics (RHC) to offset the cost of MAT training (6083).  It also clarifies (1009) and reduces barriers to payment (2001) and registration (3232) for SUD telemedicine.

On regulation of the opioid supply, the SUPPORT calls for state-level Medicaid drug utilization review (1004), as well as identification of drug orders at risk for diversion through the Automated Consolidation Ordering System (ARCOS) for manufacturers (3271-3274), reporting and databasing of suspicious DEA registrants (3291-3292), and $75 million for outreach grants to outlier prescribers (6062).  By fall 2020, HHS must notify clinicians identified as being outlier opioid prescribers; notably, prescriptions to patients on hospice or with a cancer diagnosis may be exempted from analysis.  For security, all DEA Schedule II-V prescriptions to Medicare Part D or Medicare Advantage patients must be transmitted via electronic prescription by 2021, with waivers for "reasonable technical limitation" (2003).  Opioid quotas are clarified, and the DEA must justify liberalization of future caps in terms of public health benefits (3281-3282).

Illicit drugs are addressed by giving the Department of Health and Human Services (HHS) the authority to recall or bar drugs (3012) or distributors (3013) found to cause harm and strengthens coordination between the FDA and Customs and Border Control to detect the international entry of substances (3014); this is paid for by new customs fees and international charges (8002, 8005).  On the local level, the law authorizes grants to state and local agencies to detect fentanyl and other synthetic opioids (7011).

Measures to prevent overreach includes prohibition of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey questions about pain management that don't take into account discussion of opioid risks and alternatives (6104).  Further, HHS and the Attorney General must present a report to Congress on the impacts of state and federal opioid prescribing limits (7024) - which may demonstrate unanticipated consequences.

A politically significant curiosity includes expansion of the CMS Open Payments (Sunshine Act) registry in 2022 to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives (6111).

Ultimately, the SUPPORT Act lays building blocks for a comprehensive opioid program, and does not obviously impair the practice of oncology.  Politically realities pending, more substantial future efforts may include votes on the Comprehensive Addiction Resources Emergency (CARE) Act sponsored by Sen. Elizabeth Warren and Rep. Elijah Cummings.  Modeled on the Ryan White Act of 1990 to combat the HIV/AIDS epidemic, the CARE Act would direct $100M against opioid harms. As promising as this and related initiatives may be, new legislation must be well-vetted by oncology advocates to avoid restrictions which may cause unanticipated harm to cancer patients.