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.