During yesterday’s briefing on the opioid crisis, President Donald Trump tabled the possibility of a national emergency declaration to counter the opioid epidemic – at least for now. The decision comes following the release of an interim report by the President’s opioid commission, which recommends that the President “Declare a national emergency under either the Public Health Service Act (PHSA) or the Stafford Act.”
Emergency Declarations Explained
Emergency declarations are meant to remove legal barriers or streamline implementation of a policy that would require a time-consuming legislative or regulatory approval. To date, the governors of Alaska, Arizona, Florida, Maryland, and Virginia have already declared state emergencies or disaster declarations. Such declarations have allowed naloxone to be dispensed without a prescription or required health care providers to increase reporting of overdose death rates.
While declaring a national emergency is not necessary to implement the Commission’s recommendations, it would have an impact on the states, giving them much needed resources and latitude to combat the opioid epidemic. For example, a declaration under the Stafford Act would give states access to billions of dollars under the federal Disaster Relief Fund. On the other hand, a declaration under the PHSA would grant Secretary Tom Price the ability to use a Section 1135 waiver to modify certain requirements under Medicaid and Medicare, such as physician licensing requirements, Stark self-referral sanctions and limitations on payment for health care items and services furnished to Medicare Advantage enrollees by out-of-network providers. These waivers would last during the declared emergency period or 60 days from the date the waiver was first published. In its report, the Commission provides a few examples of how a national emergency declaration could support joint state and federal efforts, such as allowing the Department of Health and Human Services (HHS) to negotiate reduced pricing for naloxone provided to law enforcement and removing the Medicaid Institutions for Mental Diseases exclusion.
The Interim Report
Since our last post the Commission has been busy working with state leaders, health policy experts and non-profit coalitions. Commission members received more than 8,000 public comments, including comments from at least 50 organizations. Membership was also finalized to include North Carolina Governor Roy Cooper (R), Congressman Patrick Kennedy (D) and Professor Bertha Madras, Ph.D – a Harvard Professor and former deputy director of the White House Office of National Drug Control Policy (ONDCP) for President George W. Bush – in addition to New Jersey Governor Chris Christie (R) and Massachusetts Governor Charlie Baker (R).
After several missed deadlines, the report was released last week and contains a set of recommendations for the President. The recommendations are as follows:
Remove Barriers to Treatment Capacity
Under existing law, federal Medicaid funds cannot be used for reimbursing services provided in inpatient facilities treating mental diseases, such as substance-use disorders (SUDs), with 16 or more beds. The heightened demand for treatment services, coupled with a shortage of treatment facilities, has made it difficult for people to find care – especially those at high risk of relapsing. A handful of states have received federal Medicaid waivers to allow for inpatient treatment, such as Massachusetts, Maryland and New York, but far more have not. Thus, the Commission recommends granting “waiver approvals for all 50 states.” Congress could remove this provision of the Social Security Act; however, the more politically expedient option is that more states should request a waiver. This would require the HHS Secretary to approve each waiver, a potentially time-consuming process. Seven states currently have waivers pending.
Mandate Prescriber Education Initiatives
According to the Centers for Disease Control (CDC), “prescription opioid-related overdose deaths increased during 1999-2010 in parallel with increased opioid prescribing.” Since 2010, the amount of opioids prescribed has decreased, but still remains high – about three times as high as 1999. Thus, changing how providers assess pain and recognize addiction is the primary goal for prescriber education initiatives. Governors Baker and Christie have both supported continuing education requirements and according to the report, “states such as Arizona, Connecticut, Pennsylvania, New York, and Utah have expanded continuing medical education requirements for opioid prescribers and dispensers.”
As such, the Commission recommend the following:
- Require continuing medical education for every physician requesting a DEA license to prescribe controlled substances;
- Require prescribers to discuss the risks of opioid dependence upon initial prescriptions;
- Urge the CDC and Food and Drug Administration (FDA) to work with the Accreditation Council for Continuing Medical Education (ACCME) to develop national training standards for opioid prescribing.
Improve Access to Medication-Assisted Treatment (MAT)
Treating opioid addiction with opioids has been regarded by some as trading one addiction for another. This has created numerous barriers within Medicaid and private insurance policies, such as limiting coverage for all three forms of medication-assisted treatment (MAT), requiring “fail first” policies and establishing limits on medication dosage. Twenty-eight states cover all three FDA-approved medications but there is significant coverage variance among these states. The Commission recommends that “CMS send a letter to state health officials requesting that state Medicaid programs cover all FDA-approved MAT drugs for opioid use disorder (OUD).”
In addition, the Commission acknowledges that individuals in the criminal justice system face numerous barriers to MAT. This can be attributed to a correctional facility’s preference for drug-free treatment programs or a lack of qualified medical staff to administer MAT drugs. This is a problem as individuals incarcerated with an OUD have the potential for withdrawal. Once released, there is also the risk of relapse and recidivism. According to the Pew Charitable Trusts, untreated OUDs amount to $7.6 billion in criminal justice costs, with 96% of those costs falling to state and local governments. The Commission recommends that the Department of Justice consult with the ONDCP to “increase the use of MAT for OUDs in these correctional settings.” However, the report does not specify how to remove these barriers.
Finally, the Commission recommends that the President direct the National Institutes of Health (NIH) to work with the pharmaceutical industry to develop “additional MAT options” and “new, non-opioid pain relievers.”
Support Model Legislation for Naloxone
The Commission’s report calls for state model legislation to “include a requirement that naloxone [be] prescribed in combination with a CDC-defined high-risk opioid being prescribed.” Further, the Commission urges the President to require that every law enforcement officer be equipped with naloxone. Such a mandate could stretch already thin state and local budgets. For example, some forms of injectable naloxone have increased in price from $690 in 2014 to $4,500. In addition, the nasal spray Narcan typically ranges from $70 to $150, according to the Virginia Department of Health.
More Data Accessibility
Forty-nine states have prescription drug monitoring programs (PDMP) and Missouri, through an executive order by Governor Eric Greitens (R), is in the process of implementing a state-wide order. The problem identified by the report is that few of these states share prescription drug information data across state lines. The Bureau of Justice Assistance and the ONDCP, led by the Integrated Justice Information Systems Institute (IJIS), has sought to address this issue through a national data hub called RxCheck. RxCheck allows states participating in the program to share prescription drug monitoring data with other states. However, as of July 13, only four states – Alabama, Florida, Maine and Kentucky – are engaged in data sharing via RxCheck. The Commission writes, “This is unacceptable” and sets a July 1, 2018 deadline for all state and federal PDMP systems to engage in interstate data sharing.
In addition, the Commission recommends that patient privacy regulations (42 CFR Part 2) for individuals with a SUD be relaxed to improve information-sharing amongst treating health care providers. By relaxed, the Commission suggests removing the requirement that a patient provide written consent in order for their SUD information to be shared with providers or even family members.
Enforce Mental Parity Laws
Finally, the Commission recommends that state and federal agencies “be required to levy penalties against health plans that violate the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).”
The Road Ahead
The Commission’s interim report, while comprehensive, is still at the beginning stages. Most, if not all, urge the President to direct a federal agency to catalyze a coordinated state and federal policy response. The report also paints a bleak picture of the cost of inaction. “With 142 Americans dying every day, America is enduring a death toll equal to September 11th every three weeks” the Commission writes. “If this scourge has not found you or your family yet, without bold action by everyone, it soon will.” The final report in October will build on these recommendations, offering an examination of more data collection and analytics along with a full review of federal obstacles to treatment. This is another opportunity for the administration to decide whether a national emergency is necessary. We will keep you updated once the final report is released with a full assessment of the impacts.