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April 16, 2018

Summary

We provide an overview of recently proposed legislation from the Senate Health, Education, Labor and Pensions Committee (HELP) and the Health Subcommittee of the House Energy and Commerce Committee to address the opioid crisis in the United States, including a large number of bills related to Medicare and Medicaid payment and coverage that could affect anesthesia and pain groups.

Committees of the House and Senate have introduced a wave of legislation to address the opioid epidemic, including more than 30 bills related to Medicare and Medicaid coverage and payment, some of which could have implications for anesthesia and pain practices.

The Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing on April 11, 2018 on the Opioid Crisis Response Act of 2018.  The proposal is an outgrowth of six bipartisan hearings held during the past six months with agencies of the Department of Health and Human Services (HHS), experts and families impacted by opioid addiction.

The bill’s overarching goal is to rally HHS agencies, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA), as well as the Departments of Education and Labor, in a multi-pronged attack on the opioid crisis in the United States, which continues to rage and which StatNews.com estimates could kill nearly half a million Americans during the next decade as the epidemic accelerates.  Drug overdoses are now the leading cause of death among Americans under the age of 50, the organization states.

Among other things, the Opioid Crisis Response Act of 2018 would:

  • Clarify the FDA’s authority to require pharmaceutical manufacturers to package certain drugs, including opioids, for set treatment durations, including three- or seven-day blister packs (pre-formed plastic packaging).
  • Authorize the FDA to require drug makers to provide patients with a simple and safe way to dispose of leftover drugs as part of the packaging. 
  • Direct the FDA to clarify requirements for a labeling claim for opioid-sparing medications that are comparably effective in controlling pain.
  • Make permanent the authority of nurse practitioners and physician assistants to prescribe medication-assisted treatment (MAT) or to prescribe MAT for up to 275 patients. (In 2016, Congress allowed physician assistants and nurse practitioners to prescribe MAT through 2021.)
  • Streamline federal requirements for state prescription drug monitoring programs (PDMPs) to give physicians and pharmacists ready access to patient information indicating a history of substance abuse or “doctor shopping.”  (In a March letter to the FDA, the American Society of Anesthesiologists called for a national PDMP, stating that such a program would “address many of the shortcomings of inconsistent state PDMPs and eventually create a uniform resource that reduces gaps in care, enables prescribers to effectively monitor patients and help prevent substance use and abuse.”)
  • Require the Secretary of HHS to prepare a report on the impact of federal and state laws regulating the length, quantity or dosage of opioid prescriptions on overdose rates, diversion and individuals for whom opioids are medically appropriate. (Also see our April 2, 2018 eAlert.)
  • Expand a grant program from the Comprehensive Addiction and Recovery Act (CARA) to allow first responders to administer naloxone and other treatments for opioid overdoses.      
  • Update and improve resources to help providers assess, diagnose, prevent, treat and manage acute and chronic pain and detect the early warning signs of opioid use disorders.
  • Streamline efforts by the NIH to find a new, non-addictive painkiller and allow the agency to use “other transactional authority” for research to respond to public health threats.

The Health Subcommittee of the House Energy and Commerce Committee also held a hearing on April 11 on a slate of bills, many of which are related to payment and coverage for opioid addiction treatment and prevention through Medicare and Medicaid. 

Among other things, the proposals would:

  • Reverse a reimbursement cut for postsurgical injections as a pain treatment alternative to opioids to incentivize the use of these alternatives.
  • Create a temporary pass through payment to encourage the development of non-opioid drugs for postsurgical pain management for Medicare beneficiaries.
  • Require e-prescribing, with exceptions, under Medicare Part D for coverage of prescription drugs that are controlled substances. 
  • Add a pain assessment as part of the Welcome to Medicare initial examination and provide intervention about non-opioid alternatives, as appropriate.
  • Direct the Centers for Medicare and Medicaid Services (CMS) to evaluate the use of abuse deterrent opioid formulations in Medicare plans.
  • Require all state Medicaid programs to set limitations for opioid refills, monitor concurrent prescribing of opioids and other drugs (such as benzodiazepines and antipsychotics), monitor antipsychotic prescribing for children, and have at least one buprenorphine/naloxone combination drug on the Medicaid drug formulary.
  • Require state Medicaid programs to integrate PDMPs into Medicaid providers’ and pharmacists’ clinical workflows; establish basic quality standards for PDMPs; and require states to report to the CMS on the numbers of providers using their PDMPs and on statewide trends in controlled substance utilization.
  • Reduce the filing window for Medicaid claims from two years to one year to help CMS, Congress and others collect timelier, more accurate and more complete expenditure data on all categories of Medicaid spending, including Medicaid drug spending.
  • Direct CMS to work with Quality Improvement Organizations to engage in outreach with prescribers identified as clinical outliers in order to share best practices.

According to a new study by the American Action Forum of the types of opioids responsible for the increasing overdose fatalities in the United States, the annual growth rate of prescription opioid-involved overdose fatalities has decreased from 13.4 percent during 1999-2010 to 4.8 percent since 2010, with heroin and synthetic opioids driving the increase in opioid-involved deaths since 2010.  The annual growth rate of heroin-involved overdose fatalities increased from 4.1 percent before 2010 to 31.2 percent after 2010, while the annual growth rate of synthetic opioid-involved overdose fatalities also increased, from 13.7 percent to 36.5 percent.  Transnational criminal organizations have been capitalizing on the opioid crisis by distributing an abundant supply of illicit and lethal opioids, the report states.

For More Information

An information statement from the American Society of Anesthesiologists on long-term opioid use in chronic, non-cancer pain conditions is available here.

The American Association of Nurse Anesthetists has developed pages on its website devoted to opioid crisis news and opioid resources.

Extensive resources on the opioid epidemic from the American Hospital Association are available here.

With best wishes,

Tony Mira
President and CEO