As you undoubtedly know, the United States is in the midst of a worsening health crisis due to the use and misuse of licit and illicit opioids, a crisis that will have a broadening impact on numerous businesses and organizations in New Jersey. Because the current opioid epidemic is considered to be the worst public health crisis in modern American history, President Donald Trump in early 2017 established by executive order the President's Commission on Combating Drug Addiction and the Opioid Crisis. Chaired by New Jersey Governor Chris Christie, the bipartisan Commission was tasked to study the scope and effectiveness of the federal response to the opioid crisis and to recommend improvements.

Following Governor Christie's appointment, I was offered a unique opportunity to take a leave of absence from my law firm, Gibbons P.C., in order to accept a six-month, full-time political appointment to serve in the leadership role of Advisor to the Executive Director of the President's Commission, supporting the governor and the Commission by overseeing the development of the Commission's work within the White House Office of National Drug Control Policy.

My goal in sharing some key takeaways from the Commission's findings is to provide insights to those industries that are affected by this crisis and the government's response¾in particular, the health care, health insurance, pharmaceutical and technology fields¾and which industries should work alongside the government to effectuate the necessary changes, in part by preparing for the consequential business and legal ramifications brought on by the Commission.

The Commission's Interim and Final Reports illustrate the importance of the private sector's cooperation to long-term success. Confronted with a worsening health crisis, Commission members set forth an expansive multimodal response entailing 65 recommendations, largely within three primary categories: prevention, treatment, and research and development. Most of those recommendations understandably advised direct changes to federal government regulations and policies. However, many were directed at the private sector, or will to some extent affect numerous businesses. With that in mind, here are a few highlighted industries that should anticipate particular executive or legislative changes at the federal and state levels.

Hospitals, Rehabilitation Facilities and Health-Care Providers

Hospitals and health-care providers should expect some of the biggest changes as a result of the Reports, as they serve critical roles in both treating those who overdose or are suffering from addiction, and preventing future patients from becoming addicted to opioids.

Among the causes of the crisis cited by the Commission were several issues that arose within the medical field over the past two decades, with the greatest responsibility placed on those that continue to be both widespread and insidious, such as insufficient medical education on pain management, opioid addictiveness and addiction diagnoses, as well as private insurance and Centers for Medicare and Medicaid Services (CMS) reimbursement policies that may inadvertently encourage doctors to prescribe opioids.

The Commission's prevention-focused recommendations center on the prescribing practices of prescription opioids. The Commission recommended that the U.S. Department of Health and Human Services (HHS) coordinate the development of a national curriculum and standard of care for opioid prescribers, and that the DEA, prior to relicensing an opioid prescriber, require participation in an approved continuing medical education program. The Commission endorsed further enhancements to, and enforced usage of, state Prescription Drug Monitoring Programs (PDMPs), which are electronic databases that give prescribers and pharmacists access to critical information regarding a patient's controlled substance prescription history. Finally, the Commission recommended revising CMS policies that encourage prescribing of opioids, such as reimbursement based on a pain survey given to patients and unequal reimbursement for FDA-approved, non-opioid pain treatments. As this partial summary of the forthcoming changes demonstrates, the Commission's work requires medical executives to prompt structural and cultural transformations to how hospitals administer services and physicians practice medicine.

Recommendations to improve treatment services for addiction will also motivate changes to the practice of addiction medicine, as the Commission placed significant emphasis on psychosocial counseling in conjunction with the expanded use of medication-assisted treatment (MAT). MAT is an evidence-based treatment for individuals with opioid use disorders; it is associated with decreasing opioid use and opioid-related overdose deaths, while improving social functioning and retention in treatment. The Commission recommended removing many of the reimbursement and policy barriers that persist despite these benefits. Accordingly, physicians should be trained in the different FDA-approved MAT medications and be prepared for an increase in patients seeking these treatments. Certain rehabilitation facilities may be required to either partner with other entities that offer these types of medical treatments or hire additional health-care workers trained in addiction medicine.

The Commission also worked to increase overall access to treatment. The Commission recommended that HHS grant each of the 50 states a waiver to the Institutes for Mental Diseases (IMD) exclusion within the Medicaid program. This component of the Social Security Act prohibits Medicaid funds from reimbursing services provided in an inpatient facility treating “mental diseases” (including substance use disorders) that have more than 16 beds. The Trump Administration has already accepted this recommendation and made it one of its marquee initiatives as a part of the national Public Health Emergency declaration for the opioid crisis (which was the chief recommendation by the Commission in its Interim Report). On Nov. 1, 2017, HHS granted the state of New Jersey a waiver to the IMD exclusion, allowing New Jersey-based hospitals and rehabilitation facilities to immediately begin expanding while still receiving Medicaid reimbursement for their services.

The Commission also supported the expansion of telemedicine to treat patients with substance use disorders as another means to increase access to treatment. The recommendations urged federal agencies to revise their respective regulations and reimbursement policies for substance use disorder treatment via telemedicine. Further developments of these technologies could play a role in ensuring access to care for those in underserved areas. Accordingly, rehabilitation facilities desiring to expand their reach should consider becoming equipped with these technologies.

Private Insurance Companies

On Oct. 20, 2017, the Commission convened a meeting with national and regional private insurance executives to discuss insurance coverage issues related to the opioid crisis. The featured topic was the Mental Health Parity and Addiction Equity Act (MHPAEA). MHPAEA is a federal law that essentially states that health insurance plans are required to offer behavioral health coverage, including for substance use disorders, that is comparable, and equal to, the coverage for medical and surgical benefits. This concept is referred to as “parity.”

Since its passage in 1996, MHPAEA has been the impetus for much of the progress in behavioral health coverage, with insurance plans eliminating clear coverage violations. The Commission discovered, however, that the violations that continue to plague the insurance industry are harder for regulators to discern; therefore, it recommended that MHPAEA be carried out using a standardized parity compliance tool.

Moreover, the Commission found that MHPAEA continues to be ineffective in achieving parity throughout insurance plans on account of insufficient enforcement. Currently, the U.S. Department of Labor (DOL) is responsible for enforcing MHPAEA; however, DOL is permitted to enforce the act only against the employer that bought the insurance plan, not against the insurance company responsible for administering the benefits. And even this enforcement is hampered, because the sole means of enforcement under the act is equitable relief.

The Commission recommended an amendment to MHPAEA, for which DOL Secretary Alexander Acosta advocated, which would provide DOL increased authority to levy monetary penalties on insurers and funders and permit DOL to launch investigations of insurers independently for parity violations. As a result of these potential federal legislative amendments, private health insurers should make sincere efforts to revamp their policies on parity compliance or face possible new severe penalties.

Pharmaceutical Companies

In its recitation of the history of the opioid crisis, the Commission catalogued the pharmaceutical industry's undeniably pivotal role in contributing to the epidemic. However, the Commission also recognized that, in order to fully combat the crisis, the industry must embrace its role of researching and developing new solutions. The Commission played a key role in establishing a public-private partnership between the National Institutes of Health (NIH) and pharmaceutical companies in order to coordinate research and development efforts to respond to the crisis. The partnership's primary goals are to develop non-addictive pain medications and new treatments for addiction and overdose.

Following Congressional appropriations, NIH looks to provide resources and clear as much bureaucratic red tape as possible for those pharmaceutical companies that focus their efforts on these initiatives. NIH hopes their combined efforts will accelerate the development of new treatments and therapies while reducing the cost of developing them.

Traditionally, medications for substance use disorders were classified as non-profitable; however, in light of the greater need for these drugs, such definitions are no longer accurate. Pharmaceutical companies should therefore recognize that this partnership could allow them to expand into a robust segment of the health market, by developing critically needed new prevention and treatment options.

Conclusion

The likely impact of the Commission has only become more assured since its conclusion. In December, President Trump assembled a number of senior officials to form an “opioids cabinet” led by Counselor to the President, Kellyanne Conway, who acted as primary liaison between the Commission and the White House, for the purpose of implementing the recommendations of the Commission. Therefore, as 2018 begins, business leaders need to adequately prepare for potentially significant changes to their industries as our nation responds to this escalating health crisis.

Marella, an associate in the Corporate Department of Gibbons P.C., in Newark, served in the White House Office of National Drug Control Policy, in support of the President's Commission on Combating Drug Addiction and the Opioid Crisis.