HHS Takes Steps to Encourage More Physicians to Prescribe Buprenorphine

Physicians with a Drug Enforcement Administration (DEA) registration number may no longer be required to apply for a separate waiver to prescribe buprenorphine to patients with opioid use disorder (OUD), according to new practice guidelines by the Department of Health and Human Services (HHS). This waiver is referred to as X-waiver of the Controlled Substances Act (CSA).

Physicians who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment have been required to complete additional certifications under Title 21 of the CSA.

“The Office of the Assistant Secretary for Health in HHS has determined that the need for physicians to make all of the certifications under 21 U.S.C. 823(g)(2)(b) represents a significant perceived barrier to prescribing buprenorphine in the United States, and removing the certification requirements would dramatically improve access to buprenorphine and save lives,” according to the guidelines.

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder outlines the following changes:

• A physician who is licensed under state law and possesses a DEA registration under 21 U.S.C. 823(f) is exempt from the certification requirements under 21 U.S.C. 823(g)(2)(b) when prescribing such medications as buprenorphine. (Physicians utilizing this exemption may treat only those patients who are located in states where those physicians are authorized to practice medicine.)
• The exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD.
• Physicians utilizing this exemption will be limited to treating no more than 30 patients with buprenorphine for OUD at any one time. (This cap does not apply to hospital-based physicians, such as emergency department physicians).
• Physicians utilizing this exemption must place an "X" on the prescription and clearly identify that the prescription is being written for OUD.
• An interagency working group will be established to monitor the implementation and results of these practice guidelines, as well as the impact on diversion.

“With this change,” said psychiatrist and immediate past AMA President Patrice Harris, M.D., M.A., in a statement, “office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime. Ensuring physician-led teams for treating patients with opioid use disorder is critical to ending the opioid epidemic. Removing the waiver requirement can also help lessen the stigma associated with this treatment and the persistent health disparities in treating substance use disorders.”

For related information, see the Psychiatric News article “Patients and Psychiatrists Alike Face Hurdles in Buprenorphine Prescribing.”

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Deaths From Illicit Opioids Rise Dramatically While Deaths From Prescription Opioids Fall

Deaths involving illicit opioids, stimulants (such as methamphetamine), heroin, and cocaine rose dramatically between 2015 and the end of 2019, according to a report released Monday by the AMA’s Opioid Task Force.

The report also showed a 37.1% decrease in opioid prescribing; wider use of state Prescription Drug Monitoring Programs; and increasing numbers of doctors trained to prescribe buprenorphine (a medication used for treating opioid use disorder).

The trends indicate that the nature of the nation’s drug overdose crisis has changed. “The nation’s drug overdose epidemic is now being driven predominantly by highly potent illicit fentanyl, heroin, methamphetamine, and cocaine, although mortality involving prescription opioids remains a top concern,” Patrice A. Harris, M.D., M.A., chair of the AMA Opioid Task Force, said in a press release. Harris is a psychiatrist and immediate past president of the AMA.

Harris emphasized the importance of naloxone, a drug that can be used to reverse an opioid overdose in an emergency. “If it weren’t for naloxone, there likely would be tens of thousands additional deaths,” she said.

Drawing on statistics from the Centers for Disease Control and Prevention, the AMA reported that from 2015 to 2019, deaths involving illicitly manufactured fentanyl and fentanyl analogs increased from 5,766 to 36,509; deaths involving stimulants increased from 4,402 to 16,279; deaths involving cocaine increased from 5,496 to 15,974; and deaths involving heroin increased from 10,788 to 14,079.

In contrast, deaths involving prescription opioids decreased from 12,269 to 11,904.

The AMA report encouraged policymakers to take the following actions to remove barriers to evidence-based care for patients with pain and those with substance use disorder:

• Remove prior authorization, step therapy, and other inappropriate administrative burdens or barriers that delay or deny care for FDA-approved medications used as part of medication-assisted treatment (MAT) for opioid use disorder.
• Enforce meaningful oversight and enforcement of state and federal mental and substance use disorder parity laws, including requiring health insurance companies to demonstrate compliance with parity laws.
• Support efforts to expand sterile needle and syringe services programs.
• Support reforms in the civil and criminal justice system that ensure access to high-quality, evidence-based care for opioid use disorder, including MAT.

“We know that ending the drug overdose epidemic will not be easy, but if policymakers allow the status quo to continue, it will be impossible,” Harris said. “This is particularly important given concerns that the COVID-19 pandemic is worsening the drug overdose epidemic. Physicians will continue to do our part. We urge policymakers to do theirs.”

For related information, see the American Journal of Psychiatry article “New Challenges in Addiction Medicine: COVID-19 Infection in Patients With Alcohol and Substance Use Disorders—The Perfect Storm.”

(Image: iStock/smartstock)

AMA President and Psychiatrist Vows to Continue Work for Equity and Justice

“Our country—indeed our world—is being challenged as never before,” said outgoing AMA President Patrice Harris, M.D., in her farewell address during AMA’s virtual meeting of the House of the Delegates yesterday. Physicians and the public are being “[c]hallenged by a novel virus for which there is not yet a specific treatment or vaccine, challenged by a lack of resources and personal protective equipment [PPE], challenged by a political climate that is highly polarized, challenged by the rampant spread of misinformation and disinformation.”

While nationwide protests continued to rage against police brutality in the aftermath of the killing of George Floyd, Harris—who is the first African American woman president of the AMA—vowed to continue to work for “equity and justice within the walls of our exam rooms, the health delivery system, the halls of Congress, and our justice system.”

Harris, who continues to be the chair of the AMA Task Force to Reduce Opioid Abuse, also vowed to work “to ensure that mental health is integrated into overall health and that there is action to address the physical and psychological consequences of early traumatic experiences.”

Harris referenced remarks in her November address at the AMA Interim Meeting in Orlando, Fla.—three months before pandemic lockdowns were initiated—in which she said physicians would always “match the moment,” rising to every occasion and continuing to earn public confidence in an era of mistrust.

“Little did any of us realize at the time how dramatically we would be put to the test,” she said. “But ‘match the moment’ we have. Physicians are working long hours in offices and hospitals, sleeping in their basements or hotels so they do not infect family members, working overtime to develop vaccines and treatments, countering the endless false narratives circulating across media channels, and reopening medical practices so we can meet the postponed health needs of our patients.”

“We applaud Dr. Harris for the completion of a successful year as the leader of the AMA,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “She served during a trying time in medicine as the COVID-19 pandemic began to arrive on our shores. She led the AMA as it pushed for resources for doctors on the front lines and for regulatory changes in Washington to help deliver care to those in need. She was an advocate for promoting evidence-based approaches to the pandemic. We are proud that a psychiatrist was able to lead the AMA during this time of great anxiety.”

Harris outlined several key organizational activities and achievements that AMA pursued during her presidential year. These include the following:

• Urgently lobbying Congress and the Trump administration to accelerate the production of PPE, test kits, and ventilators.
• Advocating for regulatory changes to facilitate remote patient visits.
• Supporting inclusion of financial support for small and independent practices in economic relief bills approved by Congress.
• Consistently calling on politicians, media outlets, and government officials to focus on science and evidence in all decision-making.

At a time of enormous national unrest, Harris vowed to be a hopeful supporter and leader of positive change. “My promise to you is that I will be guided by the direction of Dr. Martin Luther King Jr. in his final Sunday sermon—‘to remain awake through a great revolution.’ And so, as I speak to you for the last time as president of the American Medical Association. … Please know that this ‘psychiatrist is in.’ ”

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APA Member Patrice Harris, M.D., Inaugurated AMA’s 174th President

“We are no longer at a place where those with mental illness and addiction are hidden and ignored, but we are not yet at a place where mental disorders are viewed without stigma and truly integrated into health care,” said long-time APA member Patrice A. Harris, M.D., M.A., in her address last night after her inauguration as the AMA’s 174th president.

Harris, a former member of the APA Board of Trustees, was sworn in during a ceremony at the AMA’s House of Delegates meeting in Chicago. Administering the oath of office was Jack Resnick, M.D., chair of the AMA Board of Trustees.

Harris, who is the first African American woman president of the AMA, said during her address that diversity and inclusion are critical to closing the gap in health disparities and that a focus of her presidency will be on health equity and increasing the diversity of the physician workforce.

“We face big challenges in health care today, and the decisions we make now will move us forward in a future we help create,” she said. “We are no longer at a place where we can tolerate the disparities that plague communities of color, women, and the LGBTQ community. But we are not yet at a place where health equity is achieved in those communities.”

Harris also vowed to elevate mental health as a part of overall health and to increase the understanding of the impact of childhood trauma on health.

During her presidential year, Harris will continue to chair the AMA’s Task Force to Reduce Opioid Abuse, which she has chaired since its inception in 2014.

Harris served as director of health services in Fulton County, Ga., and head of the Fulton County Department of Behavioral Health and Developmental Disabilities. As chief health officer for Fulton County, she spearheaded efforts to integrate public health, behavioral health, and primary care.

First elected to the AMA Board of Trustees in 2011, she has held the executive offices of AMA board secretary and AMA board chair. In addition to her leadership of the opioid task force, Harris has been active on AMA task forces and committees dealing with such issues as health information technology, payment and delivery reform, and private contracting. She also chaired the influential AMA Council on Legislation and co-chaired the Women Physicians Congress.

She served as trustee-at-large on the APA Board of Trustees from 2001 to 2004. In addition, she was president of the Georgia Psychiatric Physicians Association and founding president of the Georgia Psychiatry Political Action Committee.

APA leaders hailed her election as an important indication of the strength of psychiatry within the House of Delegates. “We look forward to the opportunity to continuing to work with Dr. Harris on many issues, including further collaboration within the house of medicine to improve the quality of care for our patients,” said APA President Bruce Schwartz, M.D.

APA CEO and Medical Director Saul Levin, M.D., M.P.A., said, “We are honored and delighted to have a psychiatrist and long-time APA member leading the house of medicine as president of the AMA. Her work over the years at APA and the AMA will add value to her new role as the face of the AMA.”

For related information, see the Psychiatric News article “APA Member Patrice Harris Chosen AMA’s President-Elect.”

(Photo by Ted Grudzinski/AMA)

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Highlights From APA Annual Meeting: Day Two

Day two of APA’s Annual Meeting included an address by psychiatrist and incoming AMA President Patrice Harris, M.D., to APA’s Board of Trustees; a discussion of the challenges that international medical graduate students face; and a recommendation that psychiatrists consider ways their own mindfulness could benefit their patients.

Through May 22, Psychiatric News will deliver an evening digest of important highlights from the meeting.

Incoming AMA President and Former APA Board Member Lays Out Plans for Presidential Year

Psychiatrist Patrice Harris, M.D., told trustees that the integration of mental health and general medical care and promoting diversity across organized medicine would be among her priorities for the year.
Read More >

Valerie Jarrett Shares Insights From Her Years in the White House

In a wide-ranging “fireside chat” with APA President Altha Stewart, M.D., Valerie Jarrett talked about the experience of serving as President Obama’s longest-serving senior adviser. Read More >

Childhood Trauma Changes Biology of Brain

Advances in neurobiology and genetics explain the links between early life adversity and increased risk for psychiatric and medical conditions later in life, but how and when does psychiatry intervene?
Read More >

Why Psychiatrists Must 'Mindfully' Embrace Nutritional Wellness for Themselves and Their Patients

As the obesity epidemic expands, psychiatrists must go beyond telling patients how to lose weight to helping them live a healthy and fit life. Applying mindfulness to eating is one technique both physicians and their patients can benefit from.
Read More >

History Track Session Focuses on Challenges Faced by IMGs

A panel discussion of IMGs described the insensitivity and isolation—ranging from cultural misunderstandings to frank discrimination—that these trainees face in the workplace. Read More >

Overlap Between PTSD, TBI Symptoms Creates Challenges for Diagnosing Patients

Experts on Saturday discussed similarities in the causes and symptoms of PTSD and TBI, which can be critical for the determination of disability. Read More >

Winners of Resident/Medical Student Poster Competition Announced

Winners were recognized for their research focused on building resilience and addressing burnout in medical students and residents, reducing agitation, and more. Read More >

Psychiatrist Patrice Harris, M.D., M.A., Elected President-Elect of the AMA

APA member Patrice Harris, M.D., M.A., a former APA board member and AMA board member, was elected today as president-elect of the AMA during the AMA’s House of Delegates meeting in Chicago. 

“I believe our American Medical Association has well-crafted policy concerning the changing health care environment in this country,” Harris said in an address to the House following her election. “It will be my honor to represent our AMA in the venues where important issues will be debated. I am committed to preserving the central role of the physician-patient relationship in our healing art.”

Harris is the first African-American woman to hold the office.

Harris served on the AMA Board of Trustees beginning in 2011 and served as secretary for the 2014-2015 term and as chair of the board for the 2016-2017 term. As a practicing psychiatrist trained in child/adolescent and forensic psychiatry, she consults with both public and private organizations on health service delivery. She is also chair of the AMA Task Force to Reduce Opioid Abuse and is an adjunct assistant professor in the Department of Psychiatry and Behavioral Sciences at Emory University. 

“I’m elated that Dr. Harris has been elected president of the AMA,” said APA President Altha Stewart, M.D. “This is a great day for APA and for psychiatry. The APA Board of Trustees looks forward to continuing to work with her as both organizations collaborate to increase patient access to care and improve the practice of medicine.”

Harris previously served as the director of health services in Fulton County, Ga., and the head of the Fulton County Department of Behavioral Health and Developmental Disabilities. As chief health officer for Fulton County, she spearheaded efforts to integrate public health, behavioral health, and primary care. She is a past president of the Georgia Psychiatric Physicians Association.

“We are delighted to have a psychiatrist and a former APA Board of Trustees member leading the house of medicine as president-elect of the AMA,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “Her election demonstrates how psychiatrists can be leaders in medicine. We look forward to working with Dr. Harris on continued advocacy for improving the quality of care and integrating psychiatry and mental health within medicine.”

(Image: Mark Moran)

Psychiatrist Patrice Harris, M.D., Elected by AMA Trustees to Be Chair-Elect of Board

Psychiatrist Patrice Harris, M.D. (pictured left), elected yesterday to a second term as trustee on the AMA Board of Trustees, received another honor when her fellow trustees today elected her to be Chair-Elect of the board.

It’s a significant recognition of Harris’ effectiveness as a spokesperson for physicians by the leaders of American medicine. APA leaders say it testifies to the trust her fellow board members place in her and to the high regard in which she is held throughout the House of Delegates.

The AMA Board of Trustees is an elected body of 21 physicians who guide the AMA as it sets standards and policy for the medical profession. Harris is a former member of the APA Board of Trustees. “I am thrilled that Dr. Harris will serve as Chair-Elect on the AMA Board,” said APA President Renee Binder, M.D. “The APA Board of Trustees is looking forward to working with her as both groups strive to improve and advance the practice of medicine.”

APA CEO and Medical Director Saul Levin, M.D., M.P.A., noted: “It’s an honor to have one of our former Board of Trustees members re-elected to the AMA Board of Trustees and become Chair-Elect of the board. Dr. Harris will continue to carry the integration of psychiatry and mental health within the house of medicine.”

Harris has taken on several leadership roles at the AMA, including a term as chair of the AMA Council on Legislation. “It’s a great honor to be elected Chair-Elect to our AMA Board of Trustees,” Harris said. ”I am proud to be in this role and to have a strong voice for the patients we serve. My success in the AMA is in no small part due to the hard work of the members of the Section Council on Psychiatry.”

Harris is the Director of Fulton County (Ga.) Health Services and the head of the Fulton County Department of Behavioral Health and Developmental Disabilities. As director of health services for Fulton County, which includes Atlanta, Harris directs all county health services, including health partnerships that deliver a wide range of treatment and prevention services. She is a past president of the Georgia Psychiatric Physicians Association and served as a member of the AMA Women Physicians Congress. Harris also maintains a private psychiatric practice.

For more information about Harris, see the Psychiatric News articles “Patrice Harris, M.D., Elected Secretary of AMA Board” and “Psychiatrists Vie for AMA Positions: Harris Seeks Board of Trustees Seat.”

Psychiatrist Patrice Harris, M.D., Re-Elected to AMA Board of Trustees

Psychiatrist Patrice Harris, M.D. (at left), was elected to a second term as a trustee of the American Medical Association (AMA) Board of Trustees this morning during the AMA House of Delegates annual policymaking meeting in Chicago.

Harris, who is the director of health services for Fulton County, Ga., is a past member of the APA Board of Trustees. In addition to having served as a member of the AMA Women Physicians Congress and chaired the AMA Council on Legislation, Harris is a past president of the Georgia Psychiatric Physicians Association and was the founding president of that district branch's political action committee. Last year, Harris was elected secretary of the AMA Board by her fellow trustees.

In comments to the House of Delegates on Saturday, Harris recalled the words of Kent Brantly, M.D., the American physician who contracted Ebola while treating patients in Liberia: "When the going gets tough, the tough return to their calling." "What an apt description of those of us who are called to medicine," Harris said. "Our challenges are many—electronic health records, maintenance of certification, alternative payment models. But when we remember our mission and our calling, the challenges are not insurmountable. The AMA must continue to protect the practice of medicine and support physicians in choosing their own path. The challenges are real, the issues are complex, there is work to be done, and it will take all of us to do it. While I cannot promise an outcome, I can promise you the fight."

For more information about Harris, see the Psychiatric News articles “Patrice Harris, M.D., Elected Secretary of AMA Board” and “Psychiatrists Vie for AMA Positions: Harris Seeks Board of Trustees Seat.”

(Image: Ted Grudzinski/AMA)

AMA Membership Up, Harris Tells Delegates as Policymaking Meeting Begins

Membership in the AMA is up for the third year in a row, said psychiatrist and AMA Trustee Patrice Harris, M.D.

At the annual policymaking meeting of the AMA, which began this weekend in Chicago, Harris—a former member of the APA Board of Trustees—painted a bright picture of the AMA’s financial position with an increase in total revenue last year. Especially good news was the fact that in 2013 the AMA recorded an increase in membership for the third year in a row; revenue from membership dues increased across all member categories, without an increase in dues rates for members, Harris said. 

At the meeting this week, AMA delegates will be considering a number of reports and resolutions of vital interest to psychiatry, including several brought by the Section Council on Psychiatry. Among the issues to be discussed are head injuries and concussions associated with youth sports, gun violence, adequacy of health plan physician networks to provide true access to care for patients, and Medicaid payment to psychiatrists.

Harris delivered her report on AMA finances this morning at the opening of reference committee hearings where reports and resolutions are debated before being sent to the House of Delegates; the House will be meeting Monday through Wednesday. "The AMA is well positioned strategically and financially to pursue its ambitious agenda to improve the health of the nation,” Harris told delegates.


Look for additional Alerts and upcoming editions of Psychiatric News for more coverage of the AMA meeting.

(Image: Mark Moran)  

Psychiatrist Trustee of AMA: We Are Stronger Together

“I learned early on when I got involved in the advocacy arena that we are stronger when we are together,” said psychiatrist Patrice Harris, M.D., a new member of the AMA's Board of Trustees.

We are stronger when we are together. That’s the AMA’s motto, but Harris—a former member of the APA Board of Trustees—said those are not just words. “We do not defeat psychologist prescribing in Georgia, for example, without working with the Georgia Medical Society and other medical specialty societies,” Harris said, explaining the need for physicians to work together across disciplines. And she urged psychiatrists to join the AMA. Harris spoke with Psychiatric News during the annual meeting of the AMA House of Delegates this week in Chicago. At this year’s meeting the House of Delegates is considering reports and resolutions related to health care reform, Medicare payment, Medicaid reform, support for state psychiatric services, and use of antipsychotic medications in nursing homes. For coverage of these key issues, watch for future issues of Psychiatric News.

Harris is one of a number of psychiatrists who have assumed leadership positions at the AMA, including Jeremy Lazarus,  M.D., who will be inaugurated as only the second psychiatrist president of the AMA this week. For information see Psychiatric News, here. For a video of Harris’ remarks this week click here.

(Image: courtesy of Patrice Harris, M.D.)