The US Food and Drug Administration (FDA) approved Merck’s new insomnia drug, Belsomra, the first in a new class of hypnotics termed “orexin antagonists.” If you’ve never heard of orexin, put on your seat belts, because you’ll be getting a crash course from your local drug reps. Also known as hypocretins, orexins are chemicals discovered in 1998 that are secreted in the hypothalamus, and which normally function to keep us awake. It was only a matter of time before orexin blockers were developed, and Merck won the race. (TCPR will have a full take on Belsomra in our next issue.)
Generically known as suvorexant, Belsomra beats placebo in getting people to sleep, but it can cause next-day drowsiness and impaired driving. As a result, the FDA said that no more than one pill should be taken each night and the dose should not exceed 20 mg. The FDA is requiring that Merck continue to study next-day driving performance of patients taking the sedative. Belsomra is expected to be available in late 2014 or early 2015.
Impaired driving the morning after taking a sleeping pill is a phenomenon that has been recognized for more than a decade. The FDA first took action in January 2013 when it recommended cut-ting the dose of zolpidem (Ambien) by half, from 10 mg to 5 mg for immediate- release formulas, and from 12.5 mg to 6.25 mg for controlled-release formulas.
Results for Belsomra showed impaired driving in patients who took 20 mg. The FDA approved the drug in 5, 10, 15, and 20 mg doses. Merck had originally proposed that non-elderly adults start on 20 mg and increase to 40 mg if needed.
The recommended dose of Belsomra is 10 mg within 30 minutes of going to bed and patients then need to wait at least seven hours and be cautious about next-day driving.
The FDA also recommended that Belsomra be listed as a controlled substance because it can be addictive and has the potential to be abused (http://1.usa.gov/1qRWmaY). The Drug Enforcement Administration (DEA) is proposing that the drug be given a Schedule IV designation, the same as medications such as alprazolam (Xanax), clonazepam (Klonopin), and Ambien.
Should We Share Therapy Notes with Our Patients?
Like most psychiatrists, you are likely a bit wary of sharing your therapy notes with your patients. Will they be offended by reading painfully honest descriptions of their issues? Will they be confused by your use of psychiatric terminology?
Beth Israel Deaconess Medical Center in Boston is testing whether these concerns are valid. According to a report in the New York Times (http://nyti.ms/1sntbeM), the medical center has allowed about 700 patients to log on to a hospital website within days of an office visit and read their therapist’s session notes via their computer or smartphone.
A potential benefit of this program is that patients can recognize the progress they are making when they read therapists’ positive comments. But even proponents recognize that it’s a controversial idea. “We’re creating a revolution,” Dr. Tom Delbanco, a professor at Harvard and a proponent of giving patients access to therapy notes told the Times. “Some people are aghast.”
Indeed, the Times article generated over 360 comments on the newspaper’s website—both pro and con. The practice is new and there hasn’t been time for an evaluation of the benefits and risks. But Beth Israel isn’t alone in its experiment. The Department of Veteran Affairs began making medical and mental health records available online to patients last year and is only just beginning to study the effect on mental health patients, the Times said.
Step Right Up—Meaningful Use Incentives are Adding Up
In 2011, the federal government began offering financial rewards for providers to implement electronic health records (EHRs) in caring for their Medicare and Medicaid patients. For eligible doctors, these “meaningful use” incentives could provide you with extra income of up to $44,000 over five years in Medicare incentives and $63,750 in Medicaid incentives over six years.
To qualify for the Medicare program, you need to accept Medicare patients, but there is no minimum number or percentage. You must also spend less than 90% of your time practicing psychiatry in an emergency department or inpatient psych unit. For the Medicaid program, you must have a minimum of 30% Medicaid patients or practice mainly in a federally qualified health center or rural health center and have a minimum of 30% indigent patients.
The incentives have added up. As of May 2014, the government had paid out $23.7 billion in meaningful use incentives to US physicians, according to a report on the website GovernmentHealthIT (http://bit.ly/1oGJnUv).
What do you have to do to get your share of this extra spending money? We wrote about this in our December 2011 issue (http://bit.ly/U5tKwt), but in a nutshell, here’s the scoop:
• Use an EHR program “certified” by the Centers for Medicare & Medicaid Services (CMS). Ask your EHR vendor or look at the government’s official list here: http://bit.ly/1pTogwQ.
• Use the EHR program in a way defined as “meaningful,” which translates to improving patient care and communication between providers.
• Use an EHR system that allows you to maintain an up- to-date problem list/diagnosis (ie, record your patients’ diagnoses); maintain an active medication and allergy list; record your patients’ demographics; use your EHR’s drug interaction and drug allergy checking software; and use electronic prescribing.
• Record vital signs (height, weight, and blood pressure) for at least 50% of your patients, information you can obtain from patients’ PCPs.
• Record smoking status in at least 50% of all patients 13 or older.
• Provide “clinical summaries” (summaries of their diagnoses and treatments) to at least 50% of patients.
• Record a number of “clinical quality measures,” most of which you are allowed to ignore unless you are a PCP.