WASHINGTON –The Justice Department today reached a settlement agreement with Selma Medical Associates Inc. (Selma Medical), a privately owned medical facility located in Winchester, Virginia, that provides primary and specialty care to patients.

The settlement agreement resolves a complaint under Title III of the Americans with Disabilities Act (ADA) that Selma Medical refused to accept a prospective new patient for an appointment because he takes Suboxone, a medication used to treat opioid use disorder. The Justice Department’s investigation concluded that Selma Medical regularly turned away prospective new patients who lawfully take controlled substances to treat their medical conditions.

Under the agreement, Selma Medical will not deny services on the basis of disability, including opioid use disorder, or apply standards or criteria that screen out individuals with disabilities. The agreement also requires Selma Medical to adopt non-discrimination policies, train staff on its non-discrimination obligations, and report on compliance. Selma Medical will also pay $30,000 in damages to the complainant and a $10,000 civil penalty to the United States.

“This agreement ensures that people in recovery from an opioid use disorder do not face discriminatory barriers to health care services,” said Assistant Attorney General Eric Dreiband of the Civil Rights Division. “Unlawfully denying services to individuals with disabilities because of their medical conditions subjects these individuals to unwarranted stigma and harm, and will not be tolerated by the Department of Justice.”

People interested in finding out more about the ADA or this settlement agreement can call the toll-free ADA Information Line at 800-514-0301 or 800-514-0383 (TDD), or access the ADA website at http://www.ada.gov.

On January 31, 2019,  Jim Carroll, the newly sworn-in Director of the White House Office of National Drug Control Policy (ONDCP), released the Administration’s National Drug Control Strategy, which establishes the President’s priorities for addressing the challenge of drug trafficking and use.

To read the report, use this link: https://www.whitehouse.gov/wp-content/uploads/2019/01/NDCS-Final.pdf

Program Offers Free Help With Prevention, Treatment, Recovery

December 19, 2018 02:51 pm Chris Crawford – The State Targeted Response Technical Assistance (STR-TA) Consortium is now ready to assist family physicians with addressing chronic pain, opioid use disorders (OUDs) and delivery of medication-assisted treatment (MAT).

The Substance Abuse and Mental Health Services Administration awarded a two-year grant to the American Academy of Addiction Psychiatry (AAAP) to bring together a coalition of 22 health care organizations, including the AAFP, to collaborate with individuals (including family physicians), communities, states and territories to address the OUD crisis in the United States.

The coalition has fielded technical assistance teams composed of treatment, prevention and recovery consultants covering each state and territory. The Addiction Technology Transfer Center (ATTC), a core partner of the STR-TA Consortium, has identified a technology transfer specialist for each state and territory, as well. The ATTC is working closely with the single state agency/STR grantees and individuals to help identify and provide oversight for technical assistance requests and manage each state's or territory's team.

After the program officially launched on May 2, Kathryn Cates-Wessel, CEO of the AAAP, told AAFP News that this resource is not only for states with STR grants, "but also for individuals, clinical practices, community groups, and prevention and recovery programs looking for help in learning more about how to address the opioid crisis in their community with local resources and expertise."

Response So Far

Since its launch, the STR-TA program has had more than 400 requests, according to Jane Goodger, manager of outreach and communications for the AAAP.

Story Highlights §  The State Targeted Response Technical Assistance (STR-TA) Consortium is now ready to assist family physicians with addressing chronic pain, opioid use disorders (OUDs) and delivery of medication-assisted treatment. §  The Substance Abuse and Mental Health Services Administration awarded a two-year grant to the American Academy of Addiction Psychiatry (AAAP) to bring together a coalition of 22 health care organizations, including the AAFP, to collaborate with individuals, communities, states and territories to address the nation's OUD crisis. §  Since launching in May, the STR-TA program has had more than 400 requests for assistance, said Jane Goodger, manager of outreach and communications for the AAAP.

"It's been pretty amazing, considering we haven't marketed the initiative that much so far," Goodger told AAFP News. "Every time I tell somebody about this initiative, they're amazed at the types of things that we've been doing."

Goodger said submitted requests have varied greatly and include many people wanting training and others who seek to start projects such as developing opioid prevention curriculum for middle and high schools.

Specific examples of submitted requests include one from a businessman and father of a woman in recovery in Kansas City, Mo., who sought input on creating a recovery-focused high school.

"We also had a grandmother who wanted to offer a support system for other grandparents who suddenly find themselves caring for children of parents affected by the opioid crisis," Goodger said.

"We have had an incredible variety of requests that cover treatment to recovery to prevention," she added.

As for feedback from requestors, Goodger said: "They have been thrilled with this program and it's almost too good to be true to them because a lot of these people are lost -- they don't know how to solve their problems. When they come to the STR-TA, they are always happy that somebody is listening and working to help them get to wherever they need to be."

Goodger said the STR-TA program can help address almost any opioid-related issue that a family physician needs to tackle, including dealing with Medicaid and second-party payers. The program also is flexible in that it can bring a consultant in from another state if they best fit the needs of a particular request.

"We can provide treatment models for their clinics or training for their staff," she said. "Almost anything they can dream up having to do with treating opioid use disorder, preventing it and recovery, we can gather the resources to help."

Participating Family Physician's Thoughts

As a member of the STR-TA Consortium, the AAFP recruited family physicians to participate in the STR-TA program who had expertise and/or experience in OUDs and use of medications to treat them or who were interested in obtaining a waiver to prescribe medication-assisted treatment (MAT).

Darlene Petersen, M.D., of Roy, Utah, is one such family physician who was assigned to an STR-TA team that serves her home state.

Petersen has been board-certified in addiction medicine for five years and has been treating patients with OUDs using MAT in an outpatient setting for the past 11 years.

"I treat patients every day affected by opioid misuse who are in various stages of recovery," she said.

Petersen said she decided to join the STR-TA program to assist colleagues and others because Utah has consistently ranked in the top 10 states with the highest incidence of opioid misuse and she wanted to help combat the issue.

"We are here to provide assistance, from initiating treatment to (working with) special populations (i.e., pregnant women, teens, those with a dual diagnosis)," she said. "Depending on the request, the goal is to match you with a person who has the most expertise in the area that you have a question on."

Petersen said the STR-TA program is valuable to all family physicians, including solo clinicians such as herself, as a free resource that can be used as a "curbside consult" on specific patients or for training on providing MAT and the inevitable challenges and questions related to that, including about patient intakes, workflow, drug testing and instituting medication counts.

"As family physicians, we are in a unique position to identify patients with opioid dependence and provide treatment to them in a setting where they are already engaged in care," she said.

Submitting a Request

Family physicians interested in requesting assistance from the STR-TA program can visit the initiative's website and submit a request online.(getstr-ta.org)

"Within one business day, someone will schedule a call with the person to find out more about their request," Goodger said. "It's simple and easy to use, and importantly, it's free, no matter what the request. We might not be able to build a website for someone, but we can help find someone to help build a website for them.

"We've had plenty of requests, but we always have room for more."

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