Stephen Barlas

The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) flashed partial green lights to 2 manufacturers of atypical antipsychotics. The committee recommended approval for 2 new uses for Seroquel XR (quetiapine fumarate) extended-release tablets and also gave first-time approval in this country for Serdolect (sertindole).

The debate over physician involvement in assisted suicide has become relatively quiet since the federal courts and the Supreme Court, in a 6 to 3 decision on January 17, 2006, upheld Oregon’s 1997 Death With Dignity Act, which allows assisted suicide under certain conditions. However, that debate gave birth to the related controversy about the management of pain.

Psychiatrists will have to take the lead in ensuring that deep-brain stimulation (DBS)-approved by the FDA in February for the first time for use in obsessive-compulsive disorder (OCD)-is used appropriately.

The Medicare program announced it would not reevaluate for the 2010 calendar year the 2 psychiatric drug categories protected under Part D “all or substantially all.” Seniors who need antidepressants and antipsychotics will still be able to get “all or substantially all” of the chemically distinct drugs offered in those 2 categories.

The FDA is forcing manufacturers of all antiepileptic drugs to include new warnings of possible suicide ideation in the prescribing information and also to prepare a new Medication Guide to be distributed by pharmacies to consumers. In addition, the companies will have to produce a Risk Evaluation and Mitigation Strategy for each drug, which the FDA only requires for drugs with possible adverse effects it considers especially dangerous.

Psychiatrists will average a 4% fee increase in 2009 from Medicare, which compares very favorably with many other subspecialties.

The Medicare bill Congress passed last summer underlines the importance of a move to electronic prescribing by physicians.

A Supreme Court decision expected in the next 6 months will probably help to determine whether and how Congress strengthens the FDA’s authority on drug labeling.

A Blue Ribbon report and a hearing in a House subcommittee raised fresh questions about the sufficiency of the Department of Veterans Affairs (VA) response to suicides among veterans-especially those returning from Iraq and Afghanistan.

Participants in past meetings of the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) think changes to FDA advisory committee procedures announced in August will add credibility to those committee votes.

Psychiatrists were among the chief physician beneficiaries of the Medicare bill (HR 6331) that Congress passed in July. The Medicare Improvements for Patients and Providers Act of 2008 included an historic elimination of the discriminatory co-pay for Medicare outpatient mental health services.

Congress will undoubtedly set aside, one more time, a scheduled, drastic cut in Medicare fees for psychiatrists and all other physicians sometime this summer based on action in Congress before its Fourth of July recess. The House and Senate almost agreed to replace the 10.6% cut in fees scheduled for July 1 with a 1.1% increase through the end of 2009. But various political difficulties interceded, and the Bush administration stepped in and ordered a 10-day halt to any fee cuts until Congress returned to Washington.

The Supreme Court has staked out new legal ground by ruling that a judge has the right to deny a patient with schizophrenia (or anyone with a mental illness) the right to represent himself or herself in a trial-even though the court deemed him mentally qualified to stand trial.

Concern is on the rise about psychotropic medications-especially atypical antipsychotics-given to foster children covered under Medicaid. Two state Medicaid officials and a representative of the American Academy of Pediatrics (AAP) spoke at hearings of the House Ways and Means Subcommittee on Income Security and Family Support on May 8. Rep Jim McDermott, MD (D, Washington), the only psychiatrist in Congress, has introduced legislation that requires states to improve care coordination for foster children.

Concern is on the rise about psychotropic medications-especially atypical antipsychotics-given to foster children covered under Medicaid. Two state Medicaid officials and a representative of the American Academy of Pediatrics (AAP) spoke at hearings of the House Ways and Means Subcommittee on Income Security and Family Support on May 8. Rep Jim McDermott, MD (D, Washington), the only psychiatrist in Congress, has introduced legislation that requires states to improve care coordination for foster children.

Business groups are pressing the Department of Labor (DOL) to eliminate "serious mental illness resulting from stress" from the "serious health conditions" an employee can cite when requesting unpaid leave under the Family and Medical Leave Act (FMLA) of 1993. The effort is being orchestrated by the Society for Human Resource Management (SHRM) and is being backed by personnel executives at companies such as Wal-Mart.

The March 27 announcement from the FDA that it is looking into a possible connection between Merck's biggest seller, Singulair (montelukast sodium) and suicidality once again raises questions about whether the agency is requiring close enough scrutiny during clinical trials of possible connections between new drugs and psychiatric effects.

The congressional debate over expansion of the landmark 1996 Mental Health Parity Act (MHPA) rounded the bend on March 5 when the House passed a bill (HR 1424) that is considerably different from one passed last year by the Senate (S 558).

Washington Report

Congress substituted a 0.5% increase in Medicare fees for the first 6 months of 2008 for the 10% reduction that would otherwise have been enacted. That reduction in what is called the Medicare fee "update" was predetermined by a formula Congress itself put in place.

Momentum is picking up in Congress to expand the frontline federal grant program that provides money to local prisons and jails for handling of nonviolent offenders who have mental health problems.

The Senate on September 27 passed what may be the first ever veterans' mental health bill. The Joshua Omvig Veterans' Suicide Prevention Act is named after a young man who came home from Operation Iraqi Freedom with posttraumatic stress disorder (PTSD) and was unable to get mental health care from the Department of Veterans Affairs (VA).

Washington Report

The FDA is considering changes to the Patient Medication Guides (MedGuides), which must now accompany about 65 drugs, including those in 2 major classes, one of which is antidepressants. MedGuides provide information about potential adverse reactions and are considered a warning of sorts.

A House committee's passage of a mental health parity bill on July 18 seems to put the House on a collision course with the Senate, raising the possibility that Congress once again will fail to improve on the 1996 law that requires employers already offering mental health benefits to ensure limited parity with physical health benefits.

Department of Defense (DOD) medical centers, community hospitals, and clinics throughout the United States were tasked with hiring 44 "contract" psychiatrists over the summer as a response to growing concerns about inadequate mental health care for soldiers in Iraq and Afghanistan and those returning home.

Democratic control of Congress may result in the dislodging of a long-stuck bill authorizing an unspecified amount of additional federal funding for research into postpartum depression. But in hearings in a House subcommittee recently, Republicans voiced an intention to add postabortion depression to the bill's focus.

States will come under new pressure to provide mental health data to the FBI gun purchase check system if Congress passes a bill being touted as a response to the Virginia Tech catastrophe in which a student gunman with previous mental health problems shot and killed 32 people. The National Instant Criminal Background Check System (NICS) Improvement Act (HR 297) now seems destined to pass Congress this year. It would provide grants to states to help them provide a variety of data to the FBI’s NICS on whether a person has been convicted of a misdemeanor crime of domestic violence or has been the subject of court orders, mental health adjudications, or commitments.

The FDA has ordered the addition of a "black box" warning to antidepressant labeling of increased suicide risk in adults aged 18 to 24 years. The labeling will also note that no increased risk has been seen in older adults and that, in fact, the incidence of suicidal thoughts and behavior has been found to decrease during antidepressant therapy in patients 65 years and older.

Congressional embarrassment over shoddy care received by veterans at the Army's Walter Reed Medical Center has stimulated passage of 2 House bills addressing veterans' mental health care.