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.

 

With Great Doses Come Great Responsibilities

Oncologists must also protect families of cancer patients who are prescribed pain medications.

By Steve Lee, MD

To great fanfare, health services researchers at the September 2018 ASCO Quality Care Symposium announced that opioid deaths in cancer patients are ten times less likely than in the general population.  As part of a ten-year retrospective study, lead author Fumiko Chino MD of the Duke University School of Medicine reported 0.5 to 0.7 opioid deaths per 100,000 cancer patients, compared to 5 to 9 per 100,000 in the general population.  These findings, the authors argued, supported the continued carving out of cancer patients from increasingly stringent opioid prescribing laws.

These conclusions also nicely supported existing ASCO policy initiatives of reducing barriers to appropriate pain therapy and was the subject of coverage by the ASCO Post as well as an ASCO in Action podcast.

But in limiting concern of misuse of opioid misuse to cancer patients themselves, such avenues of inquiry miss the opportunity to reduce harms to caretakers and friends who gain access to harmful substances through proximity to such high doses. 

Opioid diversion has entered the public conversation, most notably with The Conners, ABC's re-reboot of the 90s classic Roseanne, in which the pilot episode portrays the opioid-related death of the fictional matriarch from a friend's supply. Real-world episodes of opioid diversion from cancer and palliative care patients have also been covered by the press including that of a daughter in Washington appropriating hundreds of opioid pills after her hospice-bound father died .

Unfortunately, rigorous study of opioid diversion is lacking, limiting policy change.  Also lacking is a clear causal narrative linking prescribed pharmaceutical opioids to the illicit substances - chiefly fentanyl - responsible for the alarming increase in American deaths reaching 72,000 in 2017. A popular hypothesis attributes the increase in fentanyl-related deaths to prescription drug control pushing users to illicit alternatives. Is caretaker prescription diversion a gateway to illicit opioids - and deaths?  Further research is needed.

Current state and federal interventions have included biologic testing, prescription drug monitoring programs (PDMPs), opioid prescribing limits, patch return, and drug takeback programs.  Few of these initiatives, however, directly address the diversion question of whether each tablet makes it to the appropriate recipient.

One solution may include directly observed therapy (DOT).  Long the domain of public health departments charged with preventing transmission of tuberculosis, innovative agencies have employed telemedicine to maintain compliance with reduced costs.   In the same way, video DOT (VDOT) is a compelling strategy for opioid tracking; in 2017, the National Institute of Drug Abuse (NIDA) funded emocha Mobile Health, a Baltimore-based VDOT start-up, to track adherence to buprenorphine.

Even if successful in trials, general rollout of interventions such as VDOT for high-dose opioid recipients such as cancer patients would surely be resource-intensive.  Important policy questions would include the party responsible for administering VDOT - physician practices are busy enough as is, pharmacy-based programs would undoubtedly add to already high drug costs, and departments of health would require new funding streams.

Ultimately, further innovation and policy are required to reduce diversion of appropriately prescribed drugs, even from legally privileged oncology and palliative care patients.