2018 saw the opioid epidemic in the US making weekly if not daily headlines. There was increased awareness and discussion of the issue. With acceptance that addiction is a disease as opposed to a personal failure, the stigma surrounding this issue continued to be removed. Treatment and prevention initiatives expanded at all levels. Insurance companies are becoming partners. The FDA started an opioid innovation challenge and is prioritizing fast-tracking devices and drug solutions. Doctors wrote fewer opioid prescriptions per the guidelines handed to them and patients living in pain started to speak out. In October, Congress passed sweeping bipartisan legislation.
Here are five key headlines from 2018 that we identified that will have considerable impact going forward in 2019 and beyond.
#1 SUPPORT bipartisan act signed into law by President
In October, President Trump signed the SUPPORT for Patients and Communities Act to combat the opioid crisis. The bill passed the House 393-8 and the Senate 98-1.
There are dozens of line items in the legislature warranting more in-depth review but here we cite four key ones that would move the dial significantly to have an impact starting in 2019.
Telemedicine for substance abuse disorder
The legislation directs CMS to expand Medicaid and Medicare coverage and eliminate barriers to use telehealth to treat substance use disorders. Among other items, CMS is to issue a report to Congress to compare services delivered via telehealth to in-person for children.
Buprenorphine prescriber base expansion
By addressing workforce shortages through provision of student loans to health professionals and grants to states as well as by increasing the numbers and capacity of current MAT (medication assisted treatment) prescribers. The legislation authorizes clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe MAT for five years. Physician assistants and nurse practitioners now have permanent authority to continue prescribing MAT. Qualified physicians can increase their numbers of MAT patients up to 275 patients.
IMD 16-bed restriction lifted
Partially repealing the Institutes for Mental Health (IMD) exclusion, the legislation now enables state Medicaid programs to be able to cover up to 30 days of services for substance use disorder treatment in an Institution for Mental Diseases for patients 21-64 years old, and, removes the 16-bed restriction.
Additional focus on pregnant women and children
Through a number of Medicaid and other provisions including access through CHIP (Children’s Health Insurance Program), the legislation expands coverage, support, and treatment for pregnant women, babies born with neonatal abstinence syndrome, and children needing mental health services.
Lost opportunity that needs future addressing in 2019:
CFR 42 – Provision to share patient information not included in final bill
Advocates such as the American Hospital Association and others were hoping that the Senate would go along with the House approval to lift the restrictions of 42 CFR Part 2, the Confidentiality of Substance Use Disorder Patient Records.
“We are disappointed that the final bill does not include a critical provision passed overwhelmingly by the House that would allow the responsible sharing of patients’ SUD treatment information in accordance with Health Insurance Portability and Accountability Act regulations. We remain committed to eliminating this statutory barrier to optimal care for our patients and will continue to seek a legislative solution.” Rick Pollack, CEO of AHA commented.
#2 Multi-suit litigation against opioid manufacturers and distributors proceeding into 2019
Pharmaceutical companies including Janssen, Purdue Pharma, Mallinckrodt, Insys Therapeutics, Noramco, Endo Pharmaceuticals, Allergan, and Teva are going to see the multiple lawsuits filed against them proceeding through the courts in 2019. Distributors including McKesson, AmerisourceBergen, and Cardinal Health as well as retailers including CVS, Rite Aid, Walgreen, and Walmart are also defendants in this landmark multi-suit litigation.
More than 1,500 cities, counties, and states have their lawsuits rolled into this multidistrict litigation. In a December 19, 2018 order U.S. District Judge Dan Aaron Polster for the U.S. District Court for the Northern District of Ohio in Cleveland allowed the bulk of the claims to go forward against the manufacturers, distributors and retailers of the prescription painkillers over what he called “a man-made plague.”
Judge Polster noted in writing – “It is accurate to describe the opioid epidemic as a man-made plague, twenty years in the making. The pain, death, and heartache it has wrought cannot be overstated. As this Court has previously stated, it is hard to find anyone in Ohio who does not have a family member, a friend, a parent of a friend, or a child of a friend who has not been affected.”
#3 FDA ad panel votes to co-prescribe Naloxone with opioids
An FDA advisory panel concluded a two-day discussion on December 18, 2018 by voting 12-11 in favor of labeling changes recommending co-prescribing the overdose antidote for opioids for high risk patients.
Some states like California, Arizona, and Vermont already have co-prescribing requirements with several others also going to implement the measure in 2019. Making Naloxone broadly available has now gained general acceptance. In April, 2018, the Surgeon General of the United States issued a public health advisory urging families and friends to start carrying the opioid overdose-reversing agent.
Advisory panel members voting against the co-prescribing of Naloxone with opioids cited cost concerns. However, with the increased scrutiny of the drug and its available formulations and generics, lower costs in 2019 will prevail.
#4 Medical marijuana adoption as opioid alternative will expand
Currently, 33 states along with the District of Columbia, Guam, and Puerto Rico have legalized medical marijuana through comprehensive public programs. 13 states have limited medical use programs.
During the summer of 2018, New York and Illinois signed laws enabling medical cannabis to be used as an alternative for opioids.
“This law will give thousands of Illinoisans who struggle with the negative side effects of opioids, including harmful addiction, another choice to manage their pain. This is not about personal opinions about cannabis. It’s about giving people more control over their own health care and pain-relief options,” Illinois Governor Bruce Rauner stated as he signed the Alternatives to Opioids Act on August 28, 2018 in Chicago.
At the federal level, marijuana remains classified as a Schedule I substance with concerns that it carries risks of being a gateway drug.
There is an urgent need for proper clinical trials to resolve the differences in opinions and provide evidence one way or the other to answer the question, “can medical marijuana be an alternative to opioid drugs and if so in which situations?”
#5 Opioid statistics worsen and don’t look like they will improve
Opioid prescriptions are decreasing but drug overdose deaths continue to increase, driven by illicit fentanyl usage. This trend is likely to continue into 2019. It is hoped that the cutting back of prescriptions for patients suffering from debilitating pain will be re-examined quickly and the CDC prescribing guidelines swiftly modified so that innocent patients are not left in the lurch.