By Charles Toutant
December 4, 2018
New Jersey Law Journal

A federal judge in Camden has granted final approval to an $84 million settlement of an antitrust class action against the American Osteopathic Association.

The suit targeted a policy requiring physicians who seek board certification in osteopathy to buy membership in the association at an annual rate of $683. The settlement calls for the AOA to end the disputed policy coupling board certification with membership in the association, and to reduce the membership fee by $90, to$593.

The settlement also calls for the AOA to waive an annual $90 certification fee for three years;allow members to take two free continuing medical education courses for free annually through December 2021; and spend $4 million between 2019 and 2021 on a brand awareness campaign for osteopathic physicians. The costs of the settlement terms over three years comes to $84.2 million.

The association has roughly 48,000 members practicing osteopathy, 32,000 of whom are AOA-board certified.The value of the settlement was calculated based on an assumption that AOA membership will decline 3 percent as a result of the elimination of the challenged rule.

The judge also approved counsel fees of $2.62 million, which is slightly less than the lodestar amount of $2.65 million. The lodestar is based on a blended rate of$601 and 4,418 hours spent investigating and litigating the case. The judge also approved service awards of $15,000 each to the four class representatives.

U.S. District Judge Noel Hillman of the District of New Jersey granted final approval to the settlement after rejecting a claim by the attorneys general of Arizona, Idaho,Louisiana, Rhode Island and Texas that the settlement is structured in a manner that conflicts with the U.S. Supreme Court’s guidance in a 2011 case, Wal-Mart Stores v. Dukes. 

The five states’attorneys general argued in an amicus curiae brief that individualized damages claims could not be certified under R. 23(b)(2) because class members may not opt out of such a settlement. The attorneys general argue that the settlement raises due process violations because under R. 23(b)(2), class members cannot opt out of the settlement and pursue individual claims for monetary damage.

But Hillman said he did not find the objections of the attorneys general compelling. The class notice clearly stated that damage claims in the suit would be extinguished in the settlement, and none of the notice recipients objected, he said. In addition, the present case did not raise concerns of collusion between named plaintiffs, class counsel and defense attorneys to resolve the case in a manner that addressed only their interests. ...

The AOA’s board of trustees approved the settlement and its House of Delegates agreed to the dues decrease, Hillman said.

“Thus, the AOA’s governing body, filling essentially the same shoes as the states’ attorneys’general under 28 U.S.C. 1715, agreed that the settlement was fair to itself as an organization as well as to its individual members. This is a classic case of institutional reform, for which Rule 23(b)(2) is the precise vehicle,” Hillman said.

Hillman noted with frustration that the efforts of the attorneys general were “seriously misguided and myopic; their ardor and zeal badly misplaced.”

The settlement reflects, “as Rule 23(b)(2) must, the concrete over the ephemeral, the real over the hypothetical, and the tangible over unfounded fears,” Hillman said.Still, amici continued “in their quixotic quest to vindicate a principle that is not offended, on behalf of their citizens who have not complained,” he said.

“And in doing so, they have succeeded in delaying approval of the settlement, have frustrated its orderly administration and ultimately sought to scuttle an agreement that promised real, tangible and substantial benefit to literally thousands of their own citizens in each of their respective states,” Hillman said.

Arizona Assistant Attorney General Drew Ensign represented the amici. A spokeswoman for the Arizona Attorney General’s office, Katie Conner, said in a statement, “We believe we flagged significant problems in the brief we filed on behalf of bipartisan attorneys general and we’re disappointed with the outcome. To date, we’ve led more than a dozen class action fairness challenges, many of them bipartisan. We’ve always put consumers first and we will continue to fight on their behalf.”

NOTICE:   A Message from the Michigan Department of Health and Human Services 

Licensees:

The Centers for Disease Control and Prevention (CDC) is providing information on: 1) the current status of a multistate outbreak of coagulopathy from exposure to synthetic cannabinoid products containing a vitamin K-epoxide cycle antagonist, brodifacoum; 2) the emergence of 2 new clinical scenarios; and 3) recommendations to help clinicians make decisions related to these 2 new clinical scenarios.

This is an update to the Health Alert Network (HAN) advisory released on May 25, 2018 titled Outbreak of Life-threatening Coagulopathy Associated with Synthetic Cannabinoids Use (https://emergency.cdc.gov/han/han00410.asp).

Outbreak Update

Since the index patient with hypocoagulopathy associated with synthetic cannabinoids use was identified on March 8, 2018 in Illinois, at least 324 people have presented to healthcare facilities with serious bleeding from possible exposure. The largest number of patients were in Illinois (164), followed by Wisconsin (86), Maryland (44), Florida (6), Pennsylvania (6), Missouri (5), North Carolina (5), Indiana (5), Kentucky (1), Virginia (1), and West Virginia (1). Laboratory investigation confirmed brodifacoum exposure in at least 150 patients. There have been at least eight (8) fatalities. Vitamin K1 continues to be the recommended therapy. Since the original HAN advisory on May 25, 2018, two (2) new clinical scenarios have emerged:

1. Several patients have outpatient follow-up blood brodifacoum concentrations that are higher than their initial blood brodifacoum concentrations.
2. At least one patient has become pregnant since starting outpatient oral Vitamin K1 treatment.

When patients are found to have outpatient follow-up blood brodifacoum concentrations higher than their initial blood brodifacoum concentrations, it strongly suggests that they have continued or resumed using synthetic cannabinoid products containing brodifacoum while on oral vitamin K1 therapy. The consequences of re-exposure to brodifacoum include:

1. Risk of life-threatening hemorrhage,
2. Oral vitamin K1 dosing may need to be increased, and
3. Oral vitamin K1 treatment duration may need to be extended.

Pregnancies in patients who are on oral vitamin K1 treatment for brodifacoum toxicity are high-risk pregnancies. Brodifacoum crosses the placenta. Both mother and fetus are at risk for serious bleeding. Brodifacoum may also be a teratogen because its chemical structure is similar to warfarin, a known teratogen.

Recommendations for Clinicians

1. Maintain a high index of suspicion for continued or resumed use of synthetic cannabinoid products containing brodifacoum in patients who are on oral vitamin K1 therapy. Ask these patients about continued or resumed use of synthetic cannabinoid products.
2. Counsel against resuming or continuing use of synthetic cannabinoid products. Refer patients to the Substance Abuse and Mental Health Services Administration (SAMHSA) national helpline, 1-800-662-HELP(4357), a free, confidential, 24/7, 365-day-a-year treatment referral and information service in English and Spanish for individuals and families facing mental and/or substance use disorders; substance abuse counseling is also available.
3. Advise patients that their current oral vitamin K1 dosing may not prevent recurrent coagulopathy from re-exposure to brodifacoum in synthetic cannabinoid products and the duration of oral vitamin K1 treatment may need to be extended.
4. Consider periodic quantitative testing of patients’ blood for brodifacoum during outpatient follow-up visits to inform if patients continued or resumed use of synthetic cannabinoid products containing brodifacoum. In addition, serial blood brodifacoum concentrations allow for calculation of blood brodifacoum half-life and assist in determining duration of oral vitamin K1 therapy.
5. Ask all women of childbearing age who are on oral vitamin K1 therapy about the possibility of being pregnant and counsel them about reliable contraceptive techniques. A periodic pregnancy test should be performed on all women of childbearing age who are on oral vitamin K1 therapy. Pregnant patients on oral vitamin K1 should be referred for high-risk pregnancy management and follow-up.
6. Contact your local poison control center (1-800-222-1222) for questions on diagnostic testing and management of these patients.
7. Promptly report possible cases to your local or state health department.

Recommendations for the Public

1. CDC recommends that people do not use synthetic cannabinoid products. Synthetic cannabinoid products are always dangerous because it is impossible for people to know what chemicals are in the product, how much they are being exposed to, and how their body will react to the chemicals. The synthetic cannabinoid products associated with this outbreak are especially dangerous because they contain brodifacoum, a chemical used as rat poison that can cause uncontrolled bleeding.
2. People who have used synthetic cannabinoid products in the past three months and are concerned about their health should contact their healthcare provider. Synthetic cannabinoid products users who develop any unusual bruising or bleeding should immediately seek medical attention.
3. People who are currently on oral vitamin K1 treatment for brodifacoum poisoning should not use synthetic cannabinoid products, as this can cause new or worsening bleeding and may prolong the course of vitamin K1 treatment. Substance Abuse and Mental Health Services Administration (SAMHSA) national helpline, 1-800-662-HELP(4357), is a free, confidential, 24/7, 365-day-a-year treatment referral and information service in English and Spanish for individuals and families facing mental and/or substance use disorders.
4. Women who are currently on oral vitamin K1 treatment for brodifacoum poisoning should use an effective contraceptive method to prevent pregnancy while being treated. .

For More Information

1. CDC Clinician Outreach and Communication Activity: Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use. https://content.govdelivery.com/accounts/USCDC/bulletins/21e1a0fExternal
2. Synthetic cannabinoids: What are they? What are their effects? https://www.cdc.gov/nceh/hsb/chemicals/sc/default.html

 

Synthetic cannabinoids: An Overview for Healthcare Providers: https://www.cdc.gov/nceh/hsb/chemicals/sc/healthcare.html

American Osteopathic Academy of Addiction Medicine
Update: House of Delegates 2018

The American Osteopathic Association held their annual business and House of Delegates meetings in Chicago July 16-22, 2018, which brought together more than 500 DOs and medical students to consider proposed resolutions and enact AOA policy. Dr. Margaret Kotz was our delegate and Dr. Stephen Wyatt our alternate.  Our hearty congratulations to them both for their dedication and work; both in preparation and during these meetings. 

The AOAAM submitted Resolution H-215 for consideration, which proposed that it be:

RESOLVED, that Osteopathic physicians who have completed AOA approved fellowships in Addiction Medicine be allowed to take the primary CAQ examination in Addiction Medicine; and, be it

RESOLVED, that clinical practice pathway previously approved by the AOA in Addiction Medicine be reopened for six (6) years for all DOs who wish to become certified in the subspecialty of Addiction Medicine.

Click here for a copy of Resolution H-215. 

The resolution went through an internal review process, and the HOD speaker and vice speaker noted that:

1. The resolution topic is the responsibility of the AOA Board of Trustees (BOT) and, therefore, should be considered by the AOA Bureau of Osteopathic Specialists (BOS); and
2. The resolved outcomes is not directed for policy that would necessarily effect the entire AOA.

It was requested that permission be granted to forward the AOAAM resolution to the BOS for consideration and review. The BOS would then be the entity that would forward it to the AOA BOT for consideration.

Because the BOS had been previously denied opening an Addiction Medicine CAQ, the AOAAM requested that the resolution not be removed for consideration by the HOD. Dr. Kotz then sent a letter to Dr. Boyd Buser, AOA past president, requesting that the AOA BOT review and support Resolution H-215. Dr. Buser was very supportive and indicated that the AOA BOT’s Certifying Board Services Task Force was aware of our issues and looking into a process for consideration of our resolution.

Subsequently, letters were sent to the members of the AOA BOTs assigned to review the resolution, as well as the Education Review Committee members, and all state and specialty executive directors, educating them on the history of the addiction medicine CAQ, identifying the urgent need for certified DOs to better treat our patients and the need for parity with our allopathic colleagues. Dr. Kotz, Dr. Wyatt and Ms. Vidmer argued before several committees during the HOD, as did others who supported our resolution.

On Saturday, the Educational Reference Committee amended H-215 to read the following:

That the American Osteopathic Association (AOA) directs the American Osteopathic Conjoint Examinations Committee on Addiction Medicine, under the direction of the bureau of osteopathic specialists (BOS), to create a psychometrically valid exam for certificate of added qualifications (CAQ)/ subspecialty certification in addiction medicine; and, be it further resolved, that the AOA, through the BOS, develop a certification pathway for addiction medicine; and, be it further resolved, that the AOA, through the BOS, explore the feasibility of reopening the clinical practice pathway in addiction medicine, for a limited time, and report to the house of delegates in 2019.

We were very encouraged, however when the H-215 came before the House for a vote, it was referred to the Finance Committee because the costs are estimated to exceed $100,000 and, per the AOA bylaws, must therefore be referred.

While the AOAAM is disappointed that Resolution H-215 did not advance this year, we are heartened that we gained support from many AOA BOTs, and AOA state and specialty organizations. During the next year, we will work to ensure that the Conjoint Committee complies with its directive from the BOS to create a recertification exam, which will assist the Finance Committee in their assessment of the cost of the primary.  We ask that you continue to educate your colleagues on the importance of a primary CAQ so that next year, our resolution passes. 

Our thanks again to Dr. Kotz and Dr. Wyatt, and the entire the AOAAM Board for their work. We are hopeful that soon, all osteopathic physicians who are qualified may sit for an AOA Addiction Medicine CAQ exam, just as our allopathic colleagues do through the American Board of Medical Specialties under the American Board of Preventive Medicine.

CDC launched Assessing and Addressing Opioid Use Disorder, the fifth module in a series of interactive, online trainings for healthcare providers. Participants will look at how opioid use disorder (OUD) is diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) assessment criteria, and learn how to discuss this diagnosis with patients. Providers will also examine the different types of medications used for medication-assisted therapy (MAT). This training features recommendations from the CDC Guideline for Prescribing Opioids for Chronic Pain and resources from SAMHSA, and provides sample scenarios and clinical tools and resources. This training provides free continuing education credit and is located on our Training for Providers webpage.

Previous modules include:

• Addressing the Opioid Epidemic: Recommendations from CDC
• Treating Chronic Pain Without Opioids
• Communicating With Patients
• Reducing the Risks of Opioids

More Information:

• CDC Guideline for Prescribing Opioids for Chronic Pain
• Guideline Resources for Healthcare Providers
• Online Training Series for Providers: Applying CDC’s Guideline for Prescribing Opioids
• CDC Drug Overdose Home Page

Download the flyer.

Important links: 

• www.getSTR-TA.org
• Email: str-ta@aaap.org

The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl-related substances.

https://www.deadiversion.usdoj.gov/fed_regs/rules/2018/fr0206_4.htm

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks. This provides updated information to the FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning issued on August 31, 2016.

To learn more click here: https://www.fda.gov/Drugs/DrugSafety/ucm575307.htm

Congratulations to Victoria S. Thieme, DO and the UNECOM students, who came in third place in their Research Day poster submission "Supportive or Stigmatizing: Health Professional's Attitudes in Caring for Substance Users in Maine."

The poster will be on display in the AOAAM room at OMED in Philadelphia. Stop by say hello and see the work of our students!

HELP

We Need YOU to complete this survey

            An estimated 25,000 to 30,000 Maine residents want treatment for Substance Use Disorders, but do not have access to it. Most states have similar statistics!  We need your valuable insight in identifying some of the barriers to care that people with substance use disorder are currently experiencing. We, at the University of New England College of Osteopathic Medicine, seek to gather information about health care practitioners’ perspectives regarding patients on the substance use disorder spectrum to identify challenges, barriers, and opportunities to improve the care model for both healthcare professionals and patients.

            Participation in this study is voluntary per our UNE IRB and involves a 10-minute online survey. After completing the online survey, we will reach out to you to schedule a phone or Skype interview that will take approximately 30 minutes. The follow-up interview will be recorded through our MP3 device, de-identified, and then transcribed for further analysis.

            Thank you in advance for your time! For your participation in this survey and follow up interview, you will be entered in a drawing for one of five $50 Amazon gift cards.

Click on this site:  https://goo.gl/forms/05An3W5sxfqxeeCP2 take the survey and provide us with your phone number or good email so that we can follow up with the phone interview.

Trends in the Use of Methadone, Buprenorphine, and Extended-Release Naltrexone at Substance Abuse Treatment Facilities: 2003-2015 (Update)

 Read the report: SAMHSA - The CBHSQ Report