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Summary of Landmark Johnson & Johnson Oklahoma Opioid Decision

The following summary of the Oklahoma Johnson & Johnson opioid decision is also published at Lexology.com.

The decision in the non-jury trial, Oklahoma ex rel. Mike Hunter, Attorney General of Oklahoma v. Purdue Pharma L.P. et al was filed on August 26, 2019.  The trial, which lasted for thirty-three days, focused on the State’s sole claim against the defendants for public nuisance under state statute, during which forty-two witnesses were called by the parties and 874 exhibits were submitted into evidence, along with 225 additional court exhibits.

In the first such decision in the United States among a plethora of cases filed across the nation, the Court held that the State had met its burden of proof that the defendant, Johnson & Johnson, was the cause-in-fact of the extensively described injuries and that the harm suffered was the kind recognized by the state law. Purdue and Teva Pharmaceuticals settled prior to trial. The court found no intervening causes to defeat a finding of direct and proximate cause.

Testimony ran the gamut of describing the development of opioids in the 1950s and research and development that occurred from the 1990s until recent years, and it focused on what the Court considered intentionally misleading marketing information and activities. It is noteworthy that the Court included in its findings that there was no opioid epidemic in Oklahoma through the mid-1990s, according to the state Commissioner of Mental Health.

The Court found that “Defendants, acting in concert with others, embarked on a major campaign in which they used branded and unbranded marketing to disseminate the messages that pain was being undertreated and ‘there was a low risk of abuse and a low danger’…designed to reach Oklahoma doctors through multiple means and at multiple times over the course of the doctor’s professional education and career” in the state.  The defendants were found to have deceptively marketed the concepts of “undertreatment” and “pseudoaddiction” in the effort to avoid the “addiction ditch,” to increase the volume of prescriptions and increase use by state physicians.

An Abatement Plan was relied upon to represent the cost of addiction treatment included in the: assessment and treatment at all levels for addicted individuals; supplementary treatment; public medication and disposal programs; screening; Brief Intervention and Referral to Treatment (SBIRT) for all primary care practices and emergency departments; universal screening; pain management program for state Medicaid members; education; naloxone treatment and education; law enforcement and provider licensure agency investigation activities; and perinatal preventive services.

The total yearly costs for remediation as described to the Court for 2019 is $572,102,028.  While State witnesses testified that the abatement Plan will require twenty years, the Court found that “…the State did not present sufficient evidence of the amount of time and costs necessary, beyond year one, to abate the Opioid Crisis.” Oklahoma ex rel. v. Purdue Pharma L.P. et al at 41.

In a news release, counsel for Johnson & Johnson stated that it is confident that it has strong grounds for an appeal of Oklahoma’s opioid decision. This decision is expected to influence the settlement talks taking place in Ohio currently related to thousands of pending lawsuits against twenty-two opioid manufacturers and distributors, including Purdue.

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Data breaches still HIPAA compliance concern for healthcare providers

cyber breach artworkHIPAA concerns, established in 1996 and evolving ever since, continue to be a very real compliance concern for healthcare providers. As an example, last year HHS collected $28.7 million from providers of healthcare services and payers for responses to HIPAA data breaches that HHS considered inadequate.

According to Modern Healthcare, this is $5.2 million over the prior high for settlement and penalties reported in 2016.  The data for 2018 may be skewed by the $16 million settlement by Anthem for a breach involving approximately 79 million people. That breach occurred in 2015, and the settlement was record-setting for the Office of Civil Rights.

Changes being discussed by HHS include the possibility of sharing a percentage of civil monetary penalties or monetary settlements with affected individuals; revisions to HIPAA rules that facilitate the additional information demanded by coordinated care, outcome-focused care and value-based payments; and reconciliation of behavioral health care’s 42 CFR Part 2 rules with HIPAA.

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Attorney Mary Holloway Richard authors update to AHLA publication

Mary Holloway Richard, lent her expertise to an update of the American Health Lawyers Association‘s Institutional Review Boards publication.

In preparing the third edition, the AHLA recognized the need to update the previous edition based upon changes in statutes and regulations and to incorporate new guidance reflecting expertise and current, in-depth experience with clinical research and IRB’s.

An important addition is the new chapter 17 “IRB Compliance and Internal Audits” authored by Richard.

Richard has recognized expertise in regulatory requirements and risk management in clinical research based upon involvement with both researchers and the IRB process for many years in the largest health system in the state.

The chapter brings to life a clinical research compliance plan by including the key elements and sample policies, procedures and other forms for use by researchers and research facilities, she said.

Richard advises clients regularly about FDA, HHS and OHRP requirements and lectures and writes on related topics, including regulatory requirements of the General Data Protection Regulation applicable in clinical research performed in the European Union.

For more information on the latest edition of the publication, click here.

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Oklahoma Medicaid plans offer solution for high cost of prescription drugs

In this article, Oklahoma City healthcare attorney Mary Holloway Richard discusses steps Oklahoma has taken to lower prescription drug costs for consumers.

Q: Oklahoma recently has been recognized by Secretary Alex Azar, of the U.S. Department of Health and Human Services, for innovations in its Medicaid prescription drug program designed to lower drug costs to the state. How was the state able to accomplish this feat?

A: Medicaid is a federal program that’s administered by the states. In Oklahoma, it’s administered by the Oklahoma Health Care Authority. So, while the state receives some federal funding, a good portion of Medicaid funds are supplied by the state. In order to reduce costs related to prescription drugs, Oklahoma applied to the Centers for Medicare & Medicaid Services (CMS) and was granted an amendment to the Oklahoma State Plan that facilitates prescription drug cost savings. The plan links the payment of a drug to its effectiveness and outcomes. This is essentially what we refer to as “value-based” prescription drug purchasing. CMS reports that “(t)he state plan amendment proposal submitted by Oklahoma will be the first state plan amendment permitting a state to pursue CMS-authorized supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers.” This program is part of the Trump administration’s “American Patients First” blueprint, designed to address rising drug prices.

Q: How will the amendment work in Oklahoma?

A: The amendment to the state plan, as approved by CMS, now allows Oklahoma to negotiate and enter into valued-based contracts with drug manufacturers. This means that, through identifying the most effective medications, the state can tailor its negotiations with manufacturers to drugs that have demonstrated the most success in treating patients, thereby achieving cost savings and efficiencies in treatment. Negotiating value-based contracts will supplement Oklahoma’s ability to control drug prices under its current participation in the Sovereign States Drug Consortium. The Consortium negotiates supplemental rebates on behalf of states. Oklahoma is free to accept or reject rebate offers.

Q: Are there other cost saving initiatives related to decreasing prescription drug costs?

A: Currently, certain drugs have a preferred status if they’re listed on the Medicaid State Supplemental Rebate Agreement. Almost every state Medicaid plan, including Oklahoma’s, gives the state the authority to negotiate supplemental rebate agreements with drug manufacturers. These agreements allow for rebates to be given to the state by manufacturers as least as large as those provided in the Medicaid national drug rebate agreement. Importantly, two other parts of the Trump administration’s plan to decrease drug costs include giving Medicare insurance plans greater ability to negotiate for the Medicare Program (Part B and prescription drugs) and to make drug prices transparent for consumers. The latter part of the president’s plan would require drugmakers to disclose list prices in public advertising.

 

Published: 7/10/18; by Paula Burkes
Original article: https://newsok.com/article/5600913/oklahoma-medicaid-plans-offer-solution-for-costly-prescription-drugs

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Finding the lawyer mentor to help you succeed in your career trajectory

“Forewarned is forearmed.” I adopted that as one of my guides. Nowhere is that more true than in the lawyer mentor selection process within AHLA.

I want to share some thoughts with you to make your selection more likely to lead to a meaningful mentor relationship to help you along your path in this broad, ever-changing field we have chosen.

I am passionate about many things, including mentoring and AHLA. While I mentor within my state and community, the focus there is often on facilitating connections for young lawyers looking for a job or a career change. Within AHLA, mentors additionally provide a safe place to discuss difficult issues – both legal and human relations – as well as inspiration and support to other lawyers. We have the opportunity to help other health lawyers along their career path, and to learn from those mentees.

Yet, while AHLA members may share similar passions and goals, that is not a strong basis for selection. Rather, there is a bit of magic to being selected. Obviously you need to be as transparent as possible about your goals, areas of interest (“Mentoring Topics”), and your member profile. As much information as you can share is important because you never know what it is that will draw a potential mentor to you. For example, in addition to substantive areas of health law of interest to me, I am interested in supporting young women balancing commitments to family, profession, and community. In reviewing recent mentee applications, I found that I connected with those who provided enough information so that I could connect with them., such as the young mother on the partnership track who still worked to contribute to her community and another who had moved from an in-house position to a private practice (as I did). Some of those who did not provide enough information in their profiles left me without a basis for connecting with them. I even suggested to some that they revise their profiles to tell their story and state their objectives more clearly.

In the spirit of wishing you the most satisfying, helpful, and inspiring mentor-mentee relationship, I will distill my thoughts down to the following messages of motivation:

Your story is interesting so tell enough of it – education, family, job path, current position. Let prospective mentors get to know you a bit.

Share your professional dreams, goals, objectives. Readers won’t know if they can be proper lawyer mentors without this information. Allow a prospective mentor to properly select you as his or her mentee based upon your objectives and common or complementary skill sets. You may also create a connection via disparate experiences and different skill sets, so pique the prospective mentor’s curiosity with sufficient information to determine if you two are a match.

If you want someone to provide feedback about a specific area, such as interfacing with the FBI or handling OIG investigations, or if you want your mentor to assist you in connecting within AHLA, be sure to mention those goals.

You must sell yourself truthfully, so don’t despair if it takes some time to connect with just the right mentor.

Finally, once connected to a Mentor, engage with that Mentor. AHLA recommends quarterly contact as a minimum. The responsibilities to create a meaningful relationship belong to both parties, as do the benefits of the relationship. Mentoring is a two-way street, and you will get out of it what you put into it, but it will be much less effective and satisfying – for both the mentor and mentee – if you fail to provide sufficient information upon which to base the relationship.

This Oklahoma healthcare law topic regarding mentoring was featured in the June 2018 issue of Connections, the official publication of the American Health Lawyers Association.

By Mary Holloway Richard

Mary H. Richard heads up the Health Care Practice Group at the law firm of Phillips Murrah, headquartered in Oklahoma City. Mary has a law degree from George Washington University and a master’s degree in public health administration from the Oklahoma Health Sciences Center. She began her career in ambulatory care, health services research, and health management consulting at the Texas Medical Center. She has practiced health law in private practice settings and as in-house counsel for the INTEGRIS Health system. While at INTEGRIS, she provided legal counsel on issues regarding behavioral health services, hospital operations, clinical research activities, and a variety of other topics in a number of facilities throughout the system. She is active in the AHLA and is a part of the AHLA Behavioral Task Force leadership. She served as subcommittee co-chair of the Providers/Clinicians subcommittee, Vice Chair of Publications, Vice Chair of Strategic Planning and Special Projects, and is currently Vice Chair of Membership. She continues to be active in the AHLA mentoring program by mentoring six young professionals and is an active mentor to lawyers in Oklahoma who are interested in health law. Mary is also a proud member if the Choctaw Nation of Oklahoma. Her grandfather was one of the first lawyers in Indian Territory.

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