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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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Avoiding costly violations to the Anti-Kickback Statute

In this article, Oklahoma City Healthcare Attorney Mary Holloway Richard discusses the “Anti-Kickback Statute” and potential, federal violations of the statute as it relates to providers in the healthcare industry.

What is the authority for the federal government to oversee providers’ relationships with durable medical equipment (DME) and device suppliers and drug companies, such as educational programs that would seem to benefit the patient? How active is that oversight?

The Anti-Kickback Statute (AKS) prohibits remuneration to induce referrals or use of products reimbursement by Medicare, Medicaid or other federal healthcare programs. The federal government, through its investigators and prosecutors, pursue civil remedies including fines for remuneration considered as kickbacks. Remuneration may be cash of in-kind contributions. Under the AKS both civil and criminal charges may result from an investigation by the federal government. Federal policy is designed to prevent relationships that purportedly “lead to excessive or unnecessary treatment,” drive up health care costs and inhibit free market competition. The kickback prohibition applies to all sources of referrals, even patients. For example, where the Medicare and Medicaid programs require patients to pay copays for services, you generally are required to collect that money from your patients. Routinely waiving these copays could implicate the AKS and you may not advertise that you will forgive copayments. However, providers are free to waive a copayment if the provider makes an individual determination that the patient cannot afford to pay or if reasonable collection efforts fail. In addition, providing free or discounted services to uninsured people is not prohibited. The beneficiary inducement statute (42 U.S.C. § 1320a-7a (a) (5)) also imposes civil monetary penalties on physicians who offer remuneration to Medicare and Medicaid beneficiaries to influence them to use their services.

Is the federal government even active in investigating and prosecuting under the AKS?

Yes. The Office of the Inspector General, counsel for the Department of Health and Human Services (HHS), estimated in 2018 that for every $1 spent on investigating health care fraud, $4 is recouped. The government has investigated, prosecuted and settled claims with many types of providers and continues to do so. The government does not need to prove patient harm or financial loss to the programs to show that a physician violated the Anti-Kickback Statute. A physician can be guilty of violating the AKS even if the physician actually rendered a medically necessary service. Taking money or gifts from drug or device companies or DME suppliers is not justified by arguing that providers would have prescribed that drug or ordered that wheelchair even without a kickback. An example of unlawful activities comes from the Covidien case. A supplier of vein ablation products in California and Florida, Covidien recently settled its claims with the federal government that it offered or provided free to medical practices, or at discounted rates, practice development assistance, lunch-and-learns, dinners with physicians, and market development support, such as vein screening activities designed to recruit new patients to the practices — all provided free of charge or at discounted rates. This virtually uncompensated support, according to the Department of Justice, was designed to induce the use of certain items or services, leading to excessive and unnecessary treatments and driving up health care costs for everyone.

Are there any clear guidelines for physicians and other providers?

HHS has published guidelines for providers, such as “A Roadmap for New Physicians-Avoiding Medicare and Medicaid Fraud and Abuse,” which I routinely provide to new physicians, advanced-practice nurses and other providers. Failure to follow the guidelines can be costly. For example, the outcome of the Covidien investigation was a civil settlement agreement for violation of the AKS in the amount of $17,477,947, with additional payments in excess of $2 million by the company to the states of California and Florida for claims paid by their Medicaid programs.

How are violations of the AKS usually discovered?

Violations of the AKS are often discovered through “qui tam” actions brought by employees of the practice group or those with knowledge of its practices known as “whistleblowers” or “relators.” To avoid vulnerability to qui tam actions providers are advised to adopt and implement robust compliance policies, including training providers and other personnel regarding behavior that may constitute risk under a federal regulatory analysis. It is also advisable to have operating agreements of the practice’s legal entity and written agreements reviewed by counsel in order to shift legal liability where possible.

 

Published: 4/19/19; by Paula Burkes
Original article: https://newsok.com/article/5629122/medical-practice-support-can-be-costly-to-suppliers-others

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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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