Controlled Substance Prescriptions Final Rule

Yesterday [November 28, 2007], the Drug Enforcement Administration issued a Final Rule [Docket No. DEA-287F] that amends regulations to allow practitioners the ability to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90 day supply of that controlled substance.  Schedule II drugs are those with the highest potential for abuse and are most likely to cause dependance among all controlled substances that have approved medical uses. 

In June 2005, the AAP sent a letter to the DEA Office of Diversion Control expressing concern with a provision contained in a DEA interim policy on the subject of dispensing controlled substances for the treatment of pain.  That provision stated that preparing multiple prescriptions on the same day with instructions to fill on different dates was tantamount to authorizing a refill of a Schedule II controlled substance and that doing so would conflict with a provision in the Controlled Substance Act.  The policy was widely interpreted to mean that patients would need to see their physician once every month to pick up a new prescription.   Whereas Schedule II includes common medications for the treatment of ADHD, the Academy expressed the view that the policy would impede the common sense approach to office-based management of ADHD, inconvenience patients and their caregivers, and place unworkable burdens on practices.  Subsequently, DEA published a Proposed Rule in September 2006 indicating its intent to amend the regulations in order to clarify its interpretation of the refill provision statute. 

The November 2007 Final Rule as it pertains to the question of refills and multiple prescriptions, states the following:

1. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited;
2. An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
   1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course pf professional practice;
   2. The individual practitioner provides written instructions on each prescription  (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;
   3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
   4. The issuance of multiple prescriptions as described is permissible under applicable state laws;
   5. The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.

For your convenience, this is a link to a complete copy of the Final Rule.

Physicians Hit With 14% Med Mal Premium Increase

Physicians in New York State got the news on July 2, 2007, that the New York State Insurance Department (NYSID) had approved a 14% rate increase on their med mal premiums starting July 1.  Citing "financial deterioration" of the liability carriers, the NYSID said that "the rate increase comes after years of setting rates below what was needed...and prior failure to successfully address the underlying causes of high medical malpractice costs."  The increase was accompanied by a tasking from Governor Eliot Spitzer for Insurance Superintendent Eric Dinallo to head up a task force charged with confronting "the fundamental drivers of high medical malpractice costs."  The groups will include DOH Commissioner Richard Daines, MD, and a broad range of representatives from physician and hospital associations, the insurance industry, consumer groups, health plans, trial lawyers and the Legislature.  Scheduled to report back to Governor Spitzer by the end of the year, the new task force will recommend short and long-term reform options for addressing the causes of high medical liability costs.  Health Commissioner Daines also expressed concern that "the increasing cost of medical liability insurance will drive some physicians out of the field and will discourage young people from entering the medical profession in the first place."

Sale of Healthy Foods at Schools
A.7086 / S.4169

After many months of negotiation and some procedural delays, Senator LaValle and Assemblywoman Galef have introduced comprehensive legislation to set guidelines for the sale healthy foods and beverages on school property and at school sponsored functions.  (A.7086 / S.4169)   The legislation already has 6 Senate sponsors, and 50 Assembly sponsors.

This legislation sets forth portion size and food requirements; sets forth requirements and provides for the sale of such foods in school stores, vending machines, school cafeterias; and requires the commissioner of education, in consultation with the commissioner of health, to establish a procedure for engaging school wellness committees.

This legislation replaces a bill introduced earlier in the session by Assemblywoman Galef (A.5741).

We finally have a starting point for the long process ahead.  There will certainly be opposition to this effort.  Therefore we need to come out the box with as much support as we can for this legislation.  All those familiar with the legislative process recognize that the language that we see in today’s bill is open to negotiation throughout the legislative process.  They have already received feedback for a few minor changes that were not incorporated in the initial introduction.  However, the sponsors are committed to pushing forward the legislation as currently drafted.

The sponsors have researched, conducted outreach and had internal discussion over the language of the bill since last spring.   The sponsors should be commended for the thoughtful process that they went through in drafting this comprehensive legislation.