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.

 

Shake Off the Tinsel: Five Innovations in Oncology Care Delivery to Watch in 2019

Robert M. Daly, MD

The start of a new year brings with it the promise of change. With the ongoing national shift from volume-based to value-based reimbursement, health care and oncology care have seen this shift ignite innovation that is leading to care transformation. As the landscape for care delivery shifts it is impacting all stakeholders including providers, payers, and most importantly, patients, and will hopefully lead to improvements in the quality of care.

These are five innovations to look for in 2019 in oncology care delivery that hold promise for positively disrupting the way we practice:

  1. Predictive analytics and artificial intelligence: Health care institutions and practices are just starting to leverage the richness of their electronic health record data to predict risk. These data driven models could have an impact in many different areas of oncology care including antineoplastic treatment decisions, early symptom identification and management, and identifying those at risk for acute care. However, currently these models are in their early stages and there is a need to better understand how these models impact care, including their unintentional consequences on clinician decision making, and how they can best be integrated into clinical practice. In addition, as third parties enter this space, such as Google and others, understanding how this data is monetized and who benefits from it will be essential decisions that institutions and practices will need to make. The ownership of extracting this data and leveraging it for clinical decision making will be a key competitive advantage for institutions and practices.

  2.  Patient-reported outcomes, 2.0: At the ASCO plenary session in 2017, Ethan Basch presented the survival results of his foundational clinical trial evaluating patient self-reporting of symptoms versus standard of care symptom management, demonstrating a five month improvement in overall survival. These results led many across oncology to believe patient reported outcomes should become the standard of care in cancer care delivery. However, there have been much advancement in technology since that plenary session including strides in remote monitoring and mobile applications. We saw this at the recent ASCO with abstracts on activity trackers and emoji scales. In 2019, we will look to see how these advances can be leveraged to elicit patient reported outcomes while decreasing the collection burden on patients, caregivers, and providers. How will these remote monitoring technologies evolve (e.g. monitoring of heart rate, blood pressure, temperature, PO intake in the home), how will our work force evolve to respond to them, and, further, how can this data be stored and interpreted to improve the risk models discussed above.

  3.  Complex treatment pathways: Anyone who has taken care of oncology patients on active treatment understands that when symptoms develop they often come in clusters. These patients often do not just have abdominal pain in isolation but also nausea, emesis, diarrhea, dehydration, and fatigue/malaise. Organizations and the private market have developed guidelines and pathways for management of these symptoms but they are typically designed to address a symptom in isolation and fail to recognize the complexity of co-occurring symptoms. There is a clinical need for innovative analytic strategies to identify these clusters as well as targeted interventions to address them. In this vein, the National Cancer Institute has called for clinical decision support systems that address co-occurrence. In the current environment of the Medicare Access and CHIP Reauthorization Act and the Oncology Care Model where resource utilization is being closely measured and followed, institutions and practices are compelled to bridge this gap in symptom management. In 2019, we will look to see how treatment pathways evolve to better address the complexity of the oncology patient’s symptom profile to lead to targeted supportive interventions that reduce unplanned acute care.

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4. Tele-oncology enabling care everywhere: Tele-oncology is a rapidly developing field that has the potential to be a major disruptive force in oncology. The applications are diverse including triaging and managing symptoms at home, delivering rural care, and remote second opinions. As these visits gain in sophistication over the coming year, these applications will continue to evolve. The old model of having patients come to the institution or practice for visits will hopefully give way to a new patient-focused model where more care is delivered to the patient where they are. We have already seen this in other specialties, and payers, including the federal government, are very slowly evolving policies to provide reimbursement for these telemedicine interventions.

5. Platforms for information sharing: Along with these changes in care delivery, there has also been an increase in the complexity of cancer care with the dissemination of immunotherapy across disease types and with treatment decision increasingly based on a tumor’s molecular profile. The traditional method of sharing information via journal articles has not kept up with the need of physicians to have access to this information in real time at the point of care nor does it facilitate the case-based decision making needed by physicians in the clinic. There is a demand for platforms that allow for this immediacy where oncologists can share information and ask questions of their colleagues. We have seen start-ups enter this space, such as TheMednet, and it will be interesting to see how these business models evolve in 2019 and how journals will respond to them.

In this blog, I will be doing a deeper dive into each of these topics over the coming year. Please respond in the comments below if you think I am missing any big innovation trends in 2019.

Preventing and Treating Cancer-Related Sexual Problems: From Guidelines to Practical Workflows

By Leslie R. Schover, PhD

Will2Love.com

Damage to sexual function affects roughly 60% of those treated for cancer. Sexual problems are usually severe and pervasive, decreasing desire for sex, damaging erections in men or causing genitourinary atrophy in women, and interfering with the ability to experience pleasure and orgasm. Time does not heal these dysfunctions. Medical and psychosocial treatment is typically required. Sexual problems have often ranked high among unmet needs in surveys of cancer survivors and are associated with decreased quality of life. In late 2017, ASCO published a new practice guideline and the National Comprehensive Cancer Network (NCCN) updated their menopause symptom guidelines, both agreeing that potential sexual problems should be brought up during treatment planning and assessed at follow-up. When problems are identified they should be further assessed and treated in multidisciplinary fashion.

Changing practice patterns in oncology settings is notoriously difficult. Recent surveys on patient-professional communication about oncofertility or sexuality agree that fewer than half of cancer patients recall any mention of these topics by their oncologist. Even then, discussions are usually restricted to a very brief warning about treatment side effects during the informed consent. For example, sexual dysfunction is ubiquitous after breast cancer treatment, but a recent mixed-methods study of communication between oncology professionals and women with breast cancer by Dr Jennifer Barsky Reese and colleagues, published in Patient Education and Counseling, found that only 40% of visits included some mention of the topic, initiated by the clinician 70% of the time. Conversations labelled as “in-depth” took place in only 25% of visits and tended to last only a couple of minutes. The likelihood that such brief and superficial counseling will help patients solve a complex sexual problem is slim.

Many cancer centers now have patients complete symptom checklists at each appointment. Some include one or more questions about sexual function. A weakness of this approach is that some patients with sexual problems fail to report them on the checklist. If an item on sexual function is checked, clinicians often skip discussing it out of anxiety, limited knowledge about the topic, or fear that addressing it will derail their clinic schedules. Few oncology professionals are trained to assess and manage cancer-related sexual dysfunction. Discussions about sexual issues are rarely documented in charts. If a problem is identified, referrals for specialty care are the exception rather than the rule.

A minority of large cancer centers have specialty clinics that treat men’s or women’s sexual problems, often including gynecologists, urologists, mental health professionals, advance practitioners, or specialized physical therapists. Although such clinics are a great step forward, only a small minority of patients with sexual problems benefit from them. Barriers include failure by the patient’s primary oncology team to identify a sexual concern and high out-of-pocket costs for these services due to reluctance by private insurers or Medicaid to reimburse them.

To meet the ASCO and NCCN guidelines, a different kind of workflow is needed. Both patients and professionals should be encouraged in internal publicity campaigns with posters, flyers, and videos to bring up the topic of sex and cancer. Someone on the oncology team should take 30 seconds to ask one question during treatment planning and periodically at follow-up, using a normalizing statement to put it into context: “Many patients treated for cancer notice new problems in their sex lives. Would you like help for any question or problem relating to sexuality?”

If the patient wants help, rather than adding unexpected time to a clinic visit or inpatient rounds to assess the situation, an institution should train several sexuality specialists who are available for timely consults to provide a thorough interview assessment and make appropriate referrals for specialty care as needed. Advanced practitioners are ideal since they not only can bill for an assessment visit using evaluation and management codes, but can also conduct a brief examination or order laboratory tests. Other good candidates for such training include oncology social workers, oncology nurse navigators, or mental health professionals. Training is increasingly available at specialty conferences or through comprehensive online programs.

Another step in the workflow is to provide patients with practical self-help interventions. Self-help books tend to be utilized mainly by college-educated women. Currently available books are mainly restricted to breast or prostate cancer. Most contain patient anecdotes but provide little concrete guidance on resolving problems. In contrast, internet-based Web sites or apps can be personalized to the patient’s type of cancer and can provide interactive content that encourages behavior change. The American Cancer Society has the most extensive online resources available for free at cancer.org. Most other internet content is superficial, repetitive, and often full of errors. As a breast cancer survivor commented in one of my intervention studies: “I am tired of being told to wear a camisole, use a lubricant, and get used to my new normal!” Several clinical trials have documented that online interventions can improve sexual function and satisfaction in cancer patients and their partners. Creating and maintaining online interventions is quite expensive, however, and patients are reluctant to pay for online content. Currently, the optimal solution is for hospitals or insurers to license such programs and provide them without charge to their patients.

One final challenge is meeting the needs of patients with low health literacy, language barriers, and/or poor insurance coverage. Nurse navigators could use online educational programs as a resource for more intensive counseling of patients who may have difficulty navigating them alone. When Medicaid or uninsured patients need specialty care, cancer centers may need to provide it at a loss or, if possible, refer them to community clinics.

 

The author is the founder of Will2Love and acknowledges a conflict of interest.

Advocacy: Building Relationships, Fostering Awareness, and Promoting Change

Heather Hylton, MS, PA-C

In September, ASCO held its 2018 Advocacy Summit on Capitol Hill. More than 100 advocates across 30 states joined forces to speak to Members of Congress and their staff on several key issues:

  • Clinical trials access for Medicaid patients

  • Removing barriers to providing patients with the right therapy at the right time

  • Mitigating administrative burdens for patients and clinicians

  • Robust funding support for the National Institutes of Health and the National Cancer Institute

Why is this work important?

Advocacy is about building relationships, providing the constituent’s perspective on proposed and existing policy, and speaking to the changes that we would like to see. Many organizations, including ASCO, have exceptional policy experts on staff who work diligently to advance legislative priorities and ensure members of these organizations have awareness of key policy issues affecting their patients and their practices.

Where we, as citizen advocates, can have our greatest impact is amplifying this work through focused conversations with our elected officials and their staff on how a particular issue is affecting or could affect their constituents. What resonates most is sharing specific examples—this narrative helps make an issue personal and tangible—and something the elected official should care about.

If not you, who?

 Lawmakers are responsible for having knowledge on an extensive range of subject matter areas. In Congress, few Members come from a healthcare background yet they are charged with the great responsibility of making sound decisions when it comes to healthcare-related policy matters.

With this being the case, what better resource could elected officials have than constituents working directly in the trenches of healthcare? There is no surrogate for this kind of expertise.

According to the Congressional Management Foundation, relationships are vital: 62% of congressional staff surveyed felt establishing a relationship with the District or State Director was important while nearly 80% felt advocates should establish a relationship with the legislative assistant who has jurisdiction over a specific issue area. Further, more than 90% of congressional staff surveyed reported that direct constituent interactions, either in the district office back home or in Washington, DC, have significant influence on lawmakers’ decisions. In fact, these direct interactions have been identified as being more influential than any other communications strategy.

The seat at the table

As with any kind of decision-making, we often feel challenged when we are not able to have a seat at the table or opportunity to provide input on a particular issue, especially when those making the decisions are far removed from the matter at hand.

Shirley Chisholm, former Member of Congress who made a presidential bid in 1972, once said, “If they don’t give you a seat at the table, bring a folding chair.” Advocacy work allows each of us to take a seat at the table in some way and serves as a tool to help move forward the change we want to see.

Advocacy work is something we can all do, and no experience in this area is required to have a meaningful impact. ASCO has resources available to assist advocates in preparing for conversations with elected officials and their staff at both the local and national level.

With the 116th Congress starting its work on January 3, 2019, there will be a great need to highlight issues affecting our patients and practices, and every voice will be essential to ensure our patients’ access to high-quality cancer care.

More information on ASCO’s Policy Priorities can be found here.

(L-R):  JOP  DAiS Editor Steve Lee, MD; Manish Shah, MD, FASCO;  JOP  DAiS Editor Heather Hylton, PA-C; Kristina Novick, MD; and Sanjay Goel, MD, are pictured at ASCO’s 2019 Advocacy Summit.

(L-R): JOP DAiS Editor Steve Lee, MD; Manish Shah, MD, FASCO; JOP DAiS Editor Heather Hylton, PA-C; Kristina Novick, MD; and Sanjay Goel, MD, are pictured at ASCO’s 2019 Advocacy Summit.

Three Must See Talks From the ASCO Quality Care Symposium

Three Must See Talks From the ASCO Quality Care Symposium

The ASCO Quality Care Symposium occurred this past week in Phoenix, AZ. The scorching Arizona sun shone a bright light on a variety of issues in cancer-care delivery including financial toxicity, care redesign and quality reporting in the age of the Oncology Care Model and MACRA, and patient engagement and patient-centered care.

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