Feds: “Harm Reduction Framework”
On May 15th, Substance Abuse Mental Health Services Administration (SAMHSA) published a document which seeks to “…inform SAMHSA’s harm reduction activities moving forward, as well as related policies, programs, and practices,” and “to inform SAMHSA of opportunities to work with other federal, state, tribal, and local partners toward advancing harm reduction approaches, services, and programs.” The document, called the Harm Reduction Framework, specifically acts as a “level setting” document in addressing substance use as a public health issue.
While the document includes reach within the Office of National Drug Control Policy (ONDCP) and other agencies, like the Centers for Disease Control and Prevention (CDC), it does not have any “mission control” or enforceable policy influence with the Drug Enforcement Agency (DEA) or other law enforcement, which has been a central tool in federal, state, and local government responses to drug use and the opioid epidemic. Indeed, “law enforcement” only shows up once in the document’s contents and once more in the document’s references list. Arguably, whereas the document serves well as a “level setting” opportunity between various stakeholders, which claims to include “law enforcement” personnel, this effort is admirable but will lack “teeth” due to harm reduction as a programmatic idea from a public health lens when law enforcement remains a contraindicated method of response.
SAMHSA has also asked for specific feedback on the framework by way of a public comment form, indicating an effort more to formalize the framework's ideas as a policy stance.
The form follows the flow of the document with the first question seeking general and overall feedback. The second question asks for feedback on the document’s introduction and review of the working group, why the document exists, and historical recognition of how harm reduction has operated in response to substance use. This should be relatively uncontroversial for most respondents. The majority of feedback may seek to clarify or otherwise add details which lengthen the document, if adopted, but will not necessarily impact the substance of this section. The only area which might become “sticky” is the inclusion of “sex work” among “behaviors” associated with substance use and among those who might benefit from harm reduction programming.
The next four questions seek feedback on the core chaptered content pf the document as follows:
“Pillars” of harm reduction
“Supporting Principles”
“Core Practices”
“Community-Based Harm Reduction Programs” (CBHRP)
The document’s Pillars are outlined to include:
Guided by people who use drugs (PWUD) and with lived experience of drug use (this might also include family members, intimate partners, friends, and so forth of PWUD)
The inherent value of people
Commits to deep community building and engagement
Promotes equity, rights, and reparative social justice
Offers low-barrier access and non-coercive support
Focuses on any positive change as defined by the person
Supporting Principles include:
Respecting autonomy
Practicing acceptance and hospitality
Providing support
Connecting family (biological and chosen)
Provides many pathways to wellbeing across the continuum of health and social care
Values practice based evidence and on-the-ground experiences
Cultivates relationships
Assists and not directs
Promotes safety
Engages first
Prioritizes listening
Works toward systems change
Core Practice Areas” include:
Safer practices
Safer settings
Safer access to healthcare
Safer transitions to care
Sustainable workforce and field
Sustainable infrastructure
The final segment focuses on a brief description of CBHRPs, up to and including research projects used to explore innovation and efficacy of particular programs.
This section is noted with an asterisk “as permitted by law” – a nod toward the issue of law enforcement as a primary response tool to substance use and the limitations of SAMHSA as a result.
Advocates should anticipate some funding and program initiatives to reflect the general ideas around this framework or any final product around this framework. However, those barriers as a result of law enforcement and politicized attitudes will remain a barrier and perhaps present challenges for implementing novel programs. Strategically, much like SAMHSA’s drug court grants, the agency should consider how to leverage supportive funding incentives for states and municipalities to involve themselves in any resulting programming.
The public comment period is open until August 14th.
Where Public and Private Payers Fail, Patient Assistance Programs Step In
During Community Access National Network’s Co-Infection Annual Monitoring Report, hosted during this year’s SYNC Conference, in reviewing Hepatitis C (HCV) treatment coverages offered by state Medicaid and State AIDS Drug Assistance Programs (ADAPs), I stated “ADAPs play a critical role even in Medicaid expansion states. With the cost of medications for both HIV and HCV, even making just about the Medicaid threshold can create a catastrophic gap in patient financial stability. Given the distinct exposure risks shared for both disease states, ADAP advocates should consider the advantages of their programs to fill this need.” And…
Earlier this year, I wrote a guest blog for ADAP Advocacy Association regarding the funding situation for Georgia’s AIDS Drug Assistance Program in light of shortfalls due to COVID-19. While Georgia has since enjoyed the benefit of astounding state advocates’ work, a hole in the program remains. At the bottom of Georgia’s most recent ADAP formulary a notice reads as follows: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.” Georgia wasn’t the only state to consider ceasing coverage of HCV medications, Texas did as well, though Texas has since added a single direct acting agent back into their ADAP formulary. In discussing the state’s funding shortfalls earlier this year, state representatives mentioned to providers referral to patient assistance programs in order to meet patients’ needs.
The summation here is publicly funded programs are not always aptly designed to meet the needs of vulnerable populations. Indeed, Harvard’s Center for Health Law and Policy outlines barriers to care instituted by public payers, like ADAPs and Medicaid programs, in an annual report. These barriers largely mirror the barriers to care instituted by private payers, wherein private payers argue these are necessary “cost containment” measures (otherwise referred to as “utilization management”). However, for patients, these “cost containment” measures largely amount to “care containment” measures and, frankly, do little more than push patients out of care through administrative burdens, commonly manifested as lengthy appeals processes or requirements for sobriety.
When public and private payers fail patients by refusing coverage of HCV treatments, they also fail our public health goals, perpetuating preventable illness and death. In the space where payers deny coverage and where people cannot afford coverage due to premiums or deductibles or being too high or where patients simply can’t afford insurance coverage and can’t access public programs, patient assistance programs step in. Patient assistance programs may be run and funded by medication manufacturers or by community-based funding programs and navigation information tools.
CANN’s quarterly Co-Infection Watch monitors HCV specific patient assistance programs for status and limits, in order to make identifying resources easy for patients and advocates reviewing the report.
While these tools are excellent tools of last-resort, they are limited and cannot be used as a substitute to sufficient public funding, regulation or legislation ensuring non-discriminatory plan designs, and adequate patient protections. Public payers have come a long way in abandoning caustic programmatic barriers for patients to jump through in order to access care and medication and private players have much farther to go. Regardless of circumstance, neglecting this critical medical intersection by way of foregoing HCV medication coverage is a public health and public payer program failure. All it does is kick a snowball down a hill. We’re already set to fail meeting our 2030 goals toward HCV elimination. We must do better to ensure this problem, at the very least, doesn’t grow.
Medicaid Access: HCV Medication Stalls
In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a stark warning to state managers of Medicaid programs regarding restrictive limits on accessing newly developed and emerging direct acting agents (DAAs) for the therapeutic and curative treatment of Hepatitis C. Since then, Harvard’s Center for Health Law and Policy Innovation (CHLPI) has steadily tracked the three most impactful methods of restricting access to DAAs in Medicaid programs: fibrosis restrictions, sobriety requirements, and prescribing provider requirements.
Briefly, fibrosis restrictions require a patient to have advanced in the amount of liver damage to a specific degree in order to qualify for care, sobriety requirements restrict access to DAAs based on a person’s self-attested stated or clinically documented sobriety, and prescribing provider requirements restrict recognition of “medical necessity” to that of a specialist or with consultation of specialist in order to receive coverage of a particular DAA. CHLPI’s most recent survey of Medicaid programs outlines progress of the policies of restriction by state. As of the date of the survey, 4 states maintain fibrosis restrictions, 13 states require some period of abstinence/sobriety with an additional 15 states requiring a patient to participate in some level of alcohol and/or drug screening and counseling, and 18 sates have some level of specialist prescriber requirements. Additionally, Community Access National Network’s quarterly HIV-HCV Coinfection Watch Report details which states cover which Hepatitis C therapies and DAAs under their Medicaid preferred drug lists (PDLs).
Of particular note, the 2015 CMS notice specifically highlight the practices of fibrosis stage and sobriety requirements as running counter to various provisions under Section 1927 of the Social Security Act. A 2020 legal review by CHLPI’s Phil Waters describes various case law and potential enforcement mechanisms in which to combat these restrictions, which may prove prescient for federal enforcement agencies and advocates alike. Of particular note, Waters argues the Americans with Disability Act (ADA) presents a “novel” approach in addressing the most caustic and immediate barrier to accessing DAAs by Medicaid recipients: sobriety restrictions/abstinence requirements. Waters notes opposition to this method of seeking enforcement may argue such policies “benefit” the class of persons affected by same. While 2018 guidance from the Department for Health and Human Services (HHS) recognizes substance use disorder as a disability, the same guidance specifically exempts people currently using illicit and illegal drugs from the protections afforded by the ADA.
As we referenced in a blog earlier this year, the Centers for Disease Control and Prevention (CDC) Hepatitis C surveillance data indicates an extraordinary increase in new HCV diagnoses relative to the opioid epidemic. Arguably, requiring an otherwise qualified Medicaid client to undergo additional, non-emergency treatment or engage in non-medical activities in order to gain coverage of a live saving therapy is necessarily discriminatory. After all, a particular Medicaid pharmacy and therapeutics committee cannot evaluate the degree of limitations a person’s experience with substance use disorder causes and imposing additional requirements that specifically target this particular is counter to best practices. Indeed, requiring a person to “get clean” before receiving life-saving medical care is the exact opposite of managing substance use recovery. Relieving pressures of medical need, housing, and other negative pressures related to determinants of health are what set people up for success in combating substance use.
In order for the Biden administration to fulfill its promises with regard to combating the opioid epidemic, for states to fulfill their responsibilities under the National Viral Hepatitis Strategy, and to meaningfully address the intersection of these syndemics, federal agencies tasked with enforcement of these rules and Medicaid directors should consult and act in alignment with advocates with lived experience and best practices in combating both the opioid epidemic and resulting infectious disease outbreaks and diagnosis, including HIV and Hepatitis C. Just as with strategic, culturally competent approaches to combatting HIV and STIs focus on sex-positive education and access to resources, including prevention and treatment interventions, barrier reduction is critically necessary in order to succeed in this fight. As it stands, Medicaid programs present one of the best opportunities to ensure and enact meaningful access to care in an effort to eliminate Hepatitis C. These access limiting policies also present the biggest barriers to achieving that goal.