Life Science Compliance Update

December 12, 2017

Senate Appropriations Committee Takes on the Opioid Epidemic


On December 5, 2017, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing to discuss the opioid epidemic and the possible role that Congress could play in the prevention, treatment, and recovery.

Senator Roy Blunt, the Subcommittee Chairman, opened the hearing by discussing the fact that overdose related deaths outnumber the deaths at the peak of the AIDS/HIV epidemic. Overdose deaths have also overtaken automobile accident fatalities to become the number one cause of accidental death in the United States. Senator Blunt also spoke about the three proposals he believes the Subcommittee needs to focus on moving forward. Those three proposals are: (1) understanding the best options for treating an opioid use disorder, including recognizing that behavioral health issues should be treated like any other physical health ailment; (2) stemming the number of individuals who become addicted in the first place, including improving surveillance to better understand where the problems are and where they are the most severe; and (3) developing new pain treatments as adequate alternatives to opioids.

Senator Patrick Leahy, the Senate Appropriations Committee Ranking Member, also mentioned the high rate of opioid-related deaths and heavily criticized the Trump Administration for not budgeting more money to fight the epidemic, noting that the president’s declaration of a public health emergency was “all talk and no action.”

Subcommittee Ranking Member Senator Patty Murray also criticized the Trump Administration and its response to the epidemic. She did suggest a solution, however, urging Congress to focus on restricting synthetic fentanyl — a main driving force in the opioid epidemic today.

Witnesses present at the hearing were: Francis Collins, Ph.D., Director at the National Health Institute; Patrick Kennedy, former Congressman and current member of the President’s Commission on Combatting Drug Addiction and the Opioid Crisis; Elinore McCance-Katz, Ph.D., Assistant Secretary for Mental Health and Substance Use at Substance Abuse and Mental Health Services Administration (SAMHSA); and Debra Houry, Ph.D., Director of the National Center for Injury Prevention and Control in the Centers for Disease Control and Prevention (CDC).

As with most Congressional discussions, funding played a prominent role in the hearing. Mr. Kennedy expressed concern about the lack of funding to fight the crisis. He had previously called for the Federal government to provide $10 billion a year for a decade to fight the epidemic. He stated that this number was the minimum amount that should be provided and cited that when the AIDS epidemic was at its height, Federal spending was “$24 billion of today’s dollar.” Senator Shelley Capito also voiced concerns that there are not enough resources available for states that have the most need.

Senator Leahy opined that the best way to treat individuals with opioid addiction it to prevent addiction, questioning what steps the NIH has taken to treat chronic pain without using opioids. Dr. Francis Collins, the Director at the National Health Institute, stated that there are two things to take into consideration when avoiding addiction: (1) understand the transition from acute to chronic pain, as opioids work well for acute pain when the patient is exposed to the drug for only a short amount of time; and (2) the longer the patient is prescribed to the opioid, the more likely they will transition to addiction.

Education was also discussed, with Senator Capito wondering how closely prescriptions were being tracked by the CDC and questioned why those numbers were not flagged earlier. Dr. Houry responded that the CDC has been tracking numbers for a few years and they are now sending officials to communities that have exceptionally high prescription rates to educate prescribers about over-prescribing. In that vein, Senator Dick Durbin questioned whether doctors are paying attention to CDC prescribing guidelines. Dr. Houry noted that the CDC is being more rigorous with training for physicians and nurse practitioners while they are still in school. Further, for those who are no longer in school, the CDC has started online courses that outline safe prescribing practices.

Overall, throughout the hearing, members of the Subcommittee showed bipartisan support for promoting the development of effective, non-addictive pain medications.

December 11, 2017

CMS Institutes New Medicaid Policy Regarding Opioids


Recently, the Centers for Medicare & Medicaid Services (CMS) announced a new policy to allow states to design demonstration projects that increase access to treatment for opioid use disorder (OUD) and other substance use disorders (SUD). This new demonstration policy responds to President Trump's directive and provides states with greater flexibility to design programs that improve access to high quality, clinically appropriate treatment. In addition to the new policy, CMS announced an immediate approval of both New Jersey and Utah’s demonstration waivers under the new policy.

Through this updated policy, states will be able to pay for a fuller continuum of care to treat SUD, including critical treatment in residential treatment facilities that Medicaid is unable to pay for without a waiver.

“This new demonstration policy comes as a direct result of the President’s commitment to address the opioid crisis and ensure states have immediate relief and flexibility,” said CMS Administrator Seema Verma. “Previous policies ignored the growing urgency of the national opioid epidemic and instead put onerous requirements on states that ultimately prevented individuals from accessing these needed services. The Trump Administration’s approach reflects the pressing nature of the issues states are facing on the ground.”

Previously, states were required to build out their entire delivery system for SUD treatment while also meeting rigid CMS standards before Medicaid demonstration approvals could be granted. The new policy will allow states to provide greater treatment options while improving their continuum of care over time.

New Jersey and Utah Waivers

Under the new CMS demonstration policy, New Jersey will provide a comprehensive and coordinated SUD benefit to adults and children while also allowing for the continuum of SUD services provided to Medicaid beneficiaries who reside in residential treatment facilities. The services covered as part of the SUD benefit will include residential treatment, withdrawal management, medication-assisted treatment, peer supports and targeted case management.

“CMS’ approval of New Jersey’s Medicaid Demonstration will remove a decades-old federal barrier so that thousands more New Jerseyans with the disease of addiction will have access to treatment and recovery,” said New Jersey Gov. Chris Christie. “President Trump acknowledged the need for this policy change when he addressed the nation last week and declared a national public health emergency. This is a tremendous step forward in our efforts to aggressively combat the opioid epidemic and save lives.”

Utah’s program is part of a broader delivery system reform effort to address the needs of individuals with SUD, individuals who are chronically homeless, and individuals within the justice system. The demonstration will also expand access to SUD treatment to a more complete continuum of services, including previously excluded residential treatment sites.

"I've always maintained the role of the federal government should be to provide states with the flexibility to be innovative in how they operate their Medicaid programs. Nobody knows how to address the unique challenges we face as a state better than we do,” said Utah Gov. Gary R. Herbert. “Today's announcement from the Centers for Medicare and Medicaid Services will allow us to address a specific challenge - extending health care coverage, including substance abuse and mental health services, to the homeless population. I applaud CMS for approving our waiver request, and look forward to getting to work on providing these critical services."

This policy will also help CMS evaluate how effectively the demonstration programs are working, through the collection of information and data that can be used to inform CMS on best practices and methods to specifically combat the opioid epidemic, increasing the agency’s capacity to learn what treatment delivery methods are the most effective.

December 07, 2017

Congress Taking New Approach to Opioid Epidemic


Recently, Representative Bob Latta introduced a bill into the United States House of Representatives. The bill, known as the Indexing Narcotics, Fentanyl and Opioids (INFO) Act, is intended to help create a public electronic database of information and strategies to combat the opioid crisis. The information in the database would be used to help federal, state, and local officials develop the most effective strategies to prevent addiction, treat those that are addicted, and keep prescription drugs from falling into the wrong hands. The INFO Act would also track federal funding being used to combat the epidemic.

The bill requires the Secretary of Health and Human Services (HHS) to appoint a Federal Coordinator to oversee the creation of the database, as well as coordinate related programs within HHS and serve as a liaison to state and local governments. The Federal Coordinator would work in consultation with the Department of Justice, Department of Veteran Affairs, the Office of National Drug Control Policy, and other relevant agencies.

The database would act as a central location for the public to find information on the following:

  • Federal funding allocations made available for research and treatment of opioid abuse;
  • Research relating to opioid abuse from all federal agencies, state and local governments, non-profits, law enforcement, medical experts, public health educators, and even research institutes.

The bill would also require HHS to evaluate other issues relating to pain management, addiction, prescription guidelines, treatments, trends and patterns, and effective solutions and programs used across the country.  HHS would be required to:

  • Examine causes and patterns in pain management and addiction;
  • Evaluate opioid abuse treatment programs, including medicated-assisted treatments, and determine their effectiveness;
  • Analyze opioid prescription guidelines, including types of opioids prescribed and trends, and recommend alternatives for pain treatment; and
  • Examine abuse rates among veterans versus the general population.

The Federal Coordinator would be responsible to submit a report to Congress one year after the date of enactment, and an additional report after five years, of results of any analysis, evaluation, or comparison conducted under their direction.

“Communities in Ohio and around the nation continue to suffer from the rise of opioid abuse and addiction,” said Latta. “While the magnitude of this crisis is evident in the number of opioid-related deaths, we’re still lacking basic information on the effectiveness of federal programs and other efforts. In order to develop the best plans to attack this problem, we need the best information. The INFO Act would improve data collection relating to addiction, prescription guidelines, treatment, pain management, patterns of abuse, and other areas in order to find help find solutions. When it comes to this crisis, failure is not an option.”


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