TMS for Adolescent Depression Research Study – Participants Needed

Integrative Psychiatry is excited to announce the beginning of recruitment for participation in a research study to evaluate the safety, acute, and long-term effectiveness of transcranial magnetic stimulation (TMS) with depressed adolescents, age 12 to 21. Integrative Psychiatry is one of twelve leading TMS centers selected to participate in the first randomized, blinded, sham-controlled study of the NeuroStar TMS System with depressed adolescents who have failed to respond to at least one adequate course of antidepressant pharmacotherapy. 


The study included three phases. 

All participants will receive extensive psychiatric evaluations and close follow-up during the study and the TMS treatments are provided for free. In addition, a daily stipend for travel expenses will be provided. 

For further information on this study protocol and enrollment criteria, see CliniclaTrials.gov, Identifier NCT02586688. https://clinicaltrials.gov/ct2/results?term=NCT02586688&Search=Search 

 Contact Alex Schrodt, Study Coordinator at 502-930-7881 for more information. 

Risk-Based Managed Care in Kentucky: A Second Year Implementation Report & Assessment of Beneficiary Perceptions

How has Kentucky Medicaid managed care fared after our initial one-year report? Based on 18 stakeholder interviews, document review, and focus groups across the state, we provide insights about beneficiary experiences and their perceptions of changes to care. We find that many implementation issues have stabilized since the beginning of managed care, though issues of pharmaceutical access and behavioral health care remain.

http://www.urban.org/health_policy/url.cfm?ID=412978

Malpractice Litigation Prevention

By Renee Binder, M.D.

As a forensic psychiatrist, I have reviewed multiple malpractice cases. I have identified five common areas that arise in malpractice cases which have informed my own clinical practice. I am writing this article in the hope that these pointers will help my colleagues, young and experienced, avoid malpractice lawsuits.

(1) Excellent documentation is crucial.

Most of us give excellent care to our patients, but because of our busy schedules, we often do not document very well. When we are sued, experts on both sides look at thedocumentation. It is usually assumed by the fact finders (arbitrators, juries or judges), that when physicians testify in court or at depositions, they may say that they did something even if they did not, and therefore the best defense to malpractice is good contemporaneous documentation. It is especially important to document our thinking process when we are dealing with a high-risk situation, e.g. prescribing off label, discharging a suicidal patient or prescribing/not prescribing medications to a pregnant or lactating patient.

(2) It is especially important to document risk assessments for suicide or violence risk.

For example, in one casethat went to trial, a patient committed suicide one day after discharge from an inpatient unit. The patient had been on a voluntary status with suicidal ideation. In the medical records, there was excellent documentation by the psychiatrist about suicide risk during the hospitalization and on the day of discharge. The documentation included the risk factors for suicide as well as mitigating factors.The documentation included the risk factors for suicide as well as mitigating factors and that there was a reasonable after care plan. The documentation also included the rationale for discharge including the fact that the patient insisted on discharge and did not meet the criteria for an involuntary commitment. Since the patient was on a voluntary status, he could leave if he wanted. The jury agreed unanimously that there had not been a breach in the standard of care and that the subsequent suicide was unforeseeable at the time of discharge.

In another case, a developmentally disabled clientstabbed his roommate in a Board and Care home one week after discharge from a hospital. In this case also, there was excellent documentation about violence risk factors and the thinking process behind the decision to discharge the patient back to his Board and Care Home with supervision. The documentation included the rationale that the two clients had lived together for over ten years without any prior incidents of violence. The case against the psychiatrist was dismissed.

When following outpatients on a long-term basis who have shown minimal evidence of suicidality or violence potential, psychiatrists understandably do not assess for suicide or violence risk on every visit. It can be argued that the standard of care does not necessitate such assessments. However, when the patient’s situation changes, e.g. the loss of a job or relationship, or there is report of an increase in depressive symptoms, it is important to assess and document the risk of suicide. In cases where this was not done, the argument which has prevailed at times is that the situation of the patient had changed and the psychiatrist should have done a more detailed assessment of violence or suicide risk.

(3) It is important to only treat patients within our areas of expertise.

If we have any questions about how to use a specific medication, it is important to refer the patient to or to get consultation from a clinician with more experience with that medication.

In one case, a patient died after she was treated in an emergency room with a combination of medications that were contraindicated in her situation. When in doubt, it is useful to check a website like “drugs.com”,”Lexi-Comp“oranother reference about interactions and contraindications. In another case, a patient developed severe complications from neuroleptic malignant syndrome after being given high doses of antipsychotics with a rapid upward dose titration. The actual dosage and the rate of titration were significantly higher that what was recommended in the peer-reviewed literature. In another case, a patient died of fulminant liver disease secondary tovalproic acid. The patient had had a prior history of hepatitis, but this was not recorded in the review of systems or past medical history. In addition, liver function tests were not obtained before or after starting valproic acid, until the patient developed jaundice. The implication was the clinicians in these cases did not know how to use these medications and were unaware of the potential risks.

It can be argued that psychiatrists have the skills and knowledge to use medications above recommended doses and for off-label indications. However, if doing so, psychiatrists need to obtain written and informed patient consent and document their thought process and their rationale for their prescribing practices. Otherwise, it may appear that the psychiatrist did not know the risks of their treatment plan.

(4) It is important to be aware of the institutional policies in the setting where we work.

In one case, a psychiatrist admitted a depressed, suicidal patient to the hospital. The psychiatrist wrote for level 1 observations, which meant 30-minute checks in that hospital. The psychiatrist seemed unaware of what level 1 meant. Hospital policies said that if patients are admitted with a complaint of depression or suicidal ideation, they should never be put on level 1. The policies stated that such individuals should either be put on level 2 (15 minute checks) or 1:1 observation. The patient committed suicide on the unit in between the 30 minute checks. It was very difficult to defend the actions of the psychiatrist.

(5) It is important to consider the family’s wishes in important and risky decisions (with the patient’s consent).

When there is a bad outcome, such as a suicide, the family will bring the lawsuit. There have been cases where the family was consulted and agreed with the treatment plan to discharge a patient from a hospital or release them from an emergency room. In these cases, if a suicide subsequently occurs, family members can still claim that they did not know any better because they are not professionals and were swayed by the opinions of the psychiatrist. Nevertheless, psychiatrists are in a more advantageous position concerning why they made the decision if the family agreed with this action. There have been cases where the psychiatrist discharged a patient against the wishes of the family. The family members then said that the doctor should have listened to them. If psychiatrists disagree with the recommendations of family members, psychiatrists need to document their thinking process and the basis of their decision to go against the family’s wishes.

In summary, I have described some of the lessons that I have learned in consulting about malpractice cases. Although anyone can be sued, and we all may be sued, it is helpful to be aware of what we can do as busy clinicians to minimize the likelihood of lawsuits being successful.


Renee Binder, M.D. is the Forensic Fellowship Director at the University of California, San Francisco. She is both a Past President of the American Academy of Psychiatry and the Law and a Past Chair of the APA Council on Psychiatry and the Law.

Can You Stop PTSD Before It Starts?

Farha Motiwala, M.D.
Michele Morais, M.D.
Saurabh Bhardwaj, M.D.
Nwakile Ojike, M.D.
Steven Lippmann, M.D.
University of Louisville School of Medicine
Department of Psychiatry and Behavioral Sciences

Introduction

Posttraumatic stress disorder (PTSD) has become a prominent psychiatric concern in recent years. PTSD can be induced by an emotionally traumatic incident. (1) Resistant to many conventional therapies, new modalities of intervention are being sought.(2) Strategies for the prevention of PTSD after a precipitating event are called for and one new, potential modality includes glucocorticoid administration.

Traumatic Memories

The neurotransmitter norepinephrine is produced after a stressful experience; it promotes understanding the dangerousness of the recent situation. (3,4) Thereafter, cortisol secretion facilitates an ability to cope by diminishing reemergence of fearful memories. (3,4) In PTSD, there is a dysfunction of the hypothalamic pituitary axis, with decreased levels of cortisol. Glucocorticoid receptors become hyper responsive, resulting in physiologically increased negative feedback, with a positive result on dexamethasone suppression testing. (1) That manifests clinically as PTSD. With low cortisol levels, PTSD patients are less able to effectively suppress traumatic memories. (3,4)

Hydrocortisone Prophylaxis

Oral hydrocortisone at a 20 mg dose can suppress startle responses in normal subjects and in patients with PTSD. (5) If prescribed immediately after an acutely upsetting incident, administering hydrocortisone at >35mg dosages has evidenced a reduction in the retrieval of troublesome memories in potential cases of PTSD. (4) Thus, prescribing 35 mg (or more) of hydrocortisone may inhibit the development of PTSD, if taken shortly following a severely traumatic event. Clinicians may consider this still experimental therapy as an option to prevent PTSD before it develops. The yet unapproved status of hydrocortisone pharmacotherapy for preventing PTSD must be made clear to the patient before prescribing it.

References

(1) Jones T, Moller MD. Implications of Hypothalamic-Pituitary- Adrenal Axis Functioning in Posttraumatic Stress Disorder. Journal of American Psychiatric Nurse Association 2011;17(6): 393-403

(2) Nin MS, Martinez LA, Pibiri F, Nelson M, Pinna G. Neurosteroids reduce social isolation-induced behavioral deficits: proposed link with neurosteroid-mediated upregulation of BDNF expression. Frontiers in Endocrinology 2011;2(73):1-12

(3) Blundell J, Blaiss CA, Lagace DC, Eisch AJ, Powell CM. Block of glucocorticoid synthesis during re-activation inhibits extinction of an established fear memory. Neurobiology of Learning and Memory 2011;95(4):453-460

(4) Putman P, Roelofs K. Effects of single cortisol administrations on human affect reviewed: Coping with stress through adaptive regulation of automatic cognitive processing. Psychoneuroendocrinology 2011;36:439-448

(5) Miller MW, McKinney AE, Kanter FS, Korte KJ, Lovallo WR. Hydrocortisone suppression of the fear-potentiated startle response and posttraumatic stress disorder. Psychoneuroendocrinology 2011;36:970-980

How Does the Sunshine Law Affect Me?

Bonnie L. Cook, MAS
Kentucky Psychiatric Medical Association

The Psychiatrist Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. The law requires them to collect data about any payments, ownership interests and other “transfers of value” and annually report it to Centers for Medicaid and Medicare Services “CMS” for publication in an online database. The database is scheduled to be launched next fall with financial information from 2013. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by psychiatrists and their immediate family members. The majority of the information contained in the reports will be available on a public, searchable website.

Frequently Asked Questions

What payments or transfers of value trigger reporting?

Any direct payments or transfers of value to physicians and/or teaching hospitals of $10 or more.

Indirect payments or transfers of value that a third party indicates are intended to be passed through to a physician.

Indirect payments or transfers of value when manufacturers make a payment to a third party, such as a physician organization, and then require, instruct, or direct the payment or transfer of value to be a provided to a specific physician or intended generally for physicians (in the latter case without regard as to whether specific physicians are identified in advance).

I’m not enrolled in Medicare. Does this apply to me?

Yes, the law applies regardless of whether a psychiatrist is enrolled in Medicare. It applies as long as the psychiatrist has a current license to practice.

Do I have to report if the payment is under $10.00?

Payments under $10.00 must be tracked, as they become reportable if the aggregate value exceeds $100 in any given year.

Is there a simple way to track expenses?

Yes, CMS has developed a smartphone app to track reportable transfers. It’s called “Open Payments Mobile for Psychiatrists” Manufacturers are also developing tools. KPMA will inform you when new tools are available.

When do I start keeping records?

The Sunshine Act affects payments made beginning August 1, 2013.

Who has to report?

The burden of compliance lies with the manufacturer. Manufacturers must submit reports on payments and transfers of value to CMS on a annual basis. They must report ownership interests held by psychiatrists and their immediate family members.

What’s excluded from reporting?

  • Certified and accredited CME (KPMA denotes on marketing materials if the program is accredited. The majority of our programs fall within these requirements.)
  • Buffet meals, snacks, drinks, etc. generally available to all participants of large scale events
  • Educational materials that directly benefit patients or are intended for patient use (note, textbooks are excluded)
  • Existing personal relationships
  • Product samples intended for patient use
  • Short term loan of covered device (no more than 90 days)
  • Contractual warranty
  • Covered recipient acting as a patient

Is it “bad” to be on the list?

No, the law does not prohibit interaction with industry, only that you report it.

I’m a resident. What do I do?

Nothing, residents are excluded.

What are key dates?

August 1 – December 31, 2013

Manufacturers must begin collecting and tracking transfers of payment and ownership information

September 30, 2014

CMS publishes the reported data on a public open payments website

What if my information is reported incorrectly?

Psychiatrists have the right to review their reports and challenge reports that are false, inaccurate or misleading. Psychiatrists may access their reports through an online website portal maintained by CMS. They will be provided a 45 day period to review the report and, if necessary, initiate disputes with the applicable manufacturer or GPA. There is a 15 day period to resolve disputes. It the challenged payment is not resolved within this time period, CMS will publish the payment as “disputed”. Failure to challenge an alleged mistaken payment within this time frame will result in CMS acceptance of the payment as accurate.

For further information see: