Attorney General Josh Stein Demands Documents from Opioid Manufacturers and Distributors

Attorney General Josh Stein Demands Documents from Opioid Manufacturers and Distributors

By / State News / Tuesday, 26 September 2017 04:00

RALEIGH, Sept. 19th, 2017 - Attorney General Josh Stein today announced that he is seeking documents and information from manufacturers and distributors of prescription opioids as part of multistate investigations into the opioid epidemic.
This information will allow Attorney General Stein and 40 of his colleagues to evaluate whether the manufacturers and distributors engaged in unlawful practices in the marketing, sale and distribution of prescription opioids. Attorney General Stein is on the executive committee and is taking a leadership role in these investigations.
“The opioid epidemic is among the biggest public health threats we face today,” said Attorney General Stein. “In addition to my work in advocating for policies and funding to promote prevention, treatment and enforcement, it is critical that we look at how this crisis was created and has exploded. I will hold accountable any drug manufacturer or distributor that played a role in creating or prolonging this epidemic and require that they become part of the solution.”
Nationwide and in North Carolina, opioids – prescription and illicit – are the main driver of drug overdose deaths, which now top car accidents as the number one cause of accidental death. In North Carolina, it is estimated that nearly four people die each day from accidental drug overdose.  
The Attorneys General are investigating opioid manufacturers Endo, Janssen, Teva/Cephalon, Allergan, and their related entities, as well continuing their previously announced investigation into Purdue Pharma.
Likewise, the Attorneys General are investigating opioid distributors AmerisourceBergen, Cardinal Health, and McKesson requesting documents about their opioid distribution practices.
The Attorneys General are working to determine what role the opioid manufacturers and distributors may have played in creating or prolonging this epidemic and, if culpable, determine the appropriate remedy to address this crisis.
The investigation into the manufacturers centers on the possibility that patients and doctors were misled about the addictive nature of these drugs. The investigation into distributors seeks information related to whether they fulfilled their duty to raise red flags about pharmacies’ suspicious drug orders.
DHHS Joins Forces with Prescribers and Payers to Fight the NC Opioid Epidemic
The North Carolina Department of Health and Human Services (DHHS) announced August 28th additional measures to fight the opioid epidemic, recognizing the important role of health care payers in combating opioid use and misuse. Medicaid, which provides health insurance to about 2 million North Carolinians, will now require prior approvals for certain opioid doses. And, DHHS has established a Payers’ Council to bring together health care payers across the state to partner on benefit design, member services and pharmacy policies to reduce opioid misuse and overdose.
These actions support North Carolina’s Opioid Action Plan, which was unveiled earlier this summer by Governor Roy Cooper and DHHS Secretary Mandy Cohen, M.D., and includes comprehensive strategies specific to North Carolina. It was prepared in collaboration with community partners to address the complex causes and outcomes of the opioid crisis.
“We look forward to working together to address the opioid epidemic by examining our pharmacy policies and taking steps to improve access to alternative effective pain control modalities and medications,” said Secretary Cohen. “Bringing payers together to promote policies around opioid prescribing, pain management, and treatment and recovery services is an integral part of our work with many partners to address this crisis.”
Details of the safe prescribing policies and Payers’ Council measures are listed below.
Safe Prescribing Policies. Effective yesterday, DHHS set new policies for Medicaid prescriptions for opioids and benzodiazepines. Prior approval is now required for opioid analgesic doses that:
• Exceed 120 mg of morphine equivalents per day;
• Are greater than a 14-day supply of any opioid; or
• Are non-preferred opioid products on the North Carolina Medicaid Preferred Drug List.
There are two exceptions to the prior approval requirements:
• Beneficiaries with a diagnosis of pain secondary to cancer are exempt from prior authorizations.
• Per federal law, pharmacies may dispense a 72-hour emergency supply to Medicaid beneficiaries for drugs requiring prior authorization.
These policies apply to the Medicaid and NC Health Choice programs and build on provisions of the NC Controlled Substance Reporting System and the recently passed Session Law 2017-74 Strengthen Opioid Misuse Prevention (STOP) Act.
North Carolina also has recently released a proposed program design for Medicaid transformation, which lays out the potential initiatives to combat the opioid epidemic. Specifically, DHHS is taking comments on proposals to expand the array of substance use disorders; strengthen pain management treatment capacity; enhance provider education for prescribing and managing chronic pain; provide care coordination for chronic pain beneficiaries; increase access to substance use disorder services through Carolina Cares legislation; eliminate prior authorization for an initial prescription of suboxone; and other proposed initiatives.
In addition, DHHS is bringing claims payers together.
North Carolina Payers’ Council. Claims payers, such as health insurance companies and workers’ compensation insurers, are uniquely positioned to address the opioid crisis, while also acknowledging the pain and health management needs of providers and their patients.
The N.C. Payers’ Council is being assembled by DHHS and will bring together large health payers in North Carolina to identify prescription drug and clinical benefits policies, and treatment and recovery supports. Payers participating in the Council include the State Health Plan; Medicaid; Palmetto GBA as the Jurisdiction M Medicare Administrative Contractor for North Carolina; Blue Cross and Blue Shield of North Carolina; UnitedHealthcare; Aetna; Cigna and several workers’ compensation insurers.
Once assembled, the Payers’ Council will work to identify, align and implement policies to improve health outcomes by:
• Supporting providers in judicious prescribing of opioids;
• Promoting safer and more comprehensive alternatives to pain management;
• Improving access to naloxone, substance use disorder treatment and recovery supports; and
• Engaging and empowering patients in the management of their health.
DHHS anticipates the N.C. Payers’ Council will convene its first meeting this fall.
For additional information about the state’s opioid efforts, visit ncdhhs.gov/opioids
Source: North Carolina Department of Health and Human Services.

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