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

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:

• Kentucky Psychiatric Medical Association
  
• American Medical Association
  
• Centers for Medicare and Medicaid Services
  
• American Psychiatric Association