Health Law Blog

New York has legislation pending that would require physicians to access computerized drug monitoring databases every time they write a prescription for a controlled substance.

New York officials found that of the 80,000 health care professionals licensed to prescribe pain medications and other controlled substances, only 47,000 have opened an account that would grant them access to the database that went live in February 2010. As of November 2011, only 2,216 had used the system.

Attorney General Eric Schneiderman issued a report on Jan. 11 showing that the number of prescriptions for narcotic painkillers in New York increased from 16.6 million in 2007 to 22.5 million in 2010.

Schneiderman drafted a proposed bill that would require the Dept. of Health to establish and maintain a database capable of real-time information capture. Schneiderman's proposal would require a check of the database every time a physician writes a prescription for a schedule II, III, IV, or IV controlled substance. Assemblyman Michael Cusick, a Democrat from Staten Island, and State Sen. Andrew Lanza, a Republican from Staten Island, are sponsoring the proposed bill.

The portion of the bill regarding a real-time database is meant to address a flaw in databases -- the information often is updated in an inconsistent and untimely manner.

What monitoring programs cover and how often they are updated vary from state to state. But generally, a physician is assigned a login and password to a database that shows what prescriptions a patient has filled and who has prescribed them. The information can be used either to initiate addiction treatment or to report illegal activity.

An estimated 20 million Americans 12 and older have used prescription drugs for nonmedical reasons, according to the National Institutes of Health. Forty-eight states have enacted legislation to create a prescription drug monitoring program to help combat the rising epidemic, according to the National Alliance for Model State Drug Laws. Thirty-seven of those states have a program up and running, but several have found use of the system is either very low or not keeping pace with the abuse the programs are meant to detect and reduce.

Effective October 1, 2011, pharmacy providers must obtain a signature from the beneficiary or their designee confirming receipt of the pharmacy service(s). This policy applies to all pick-ups, home deliveries and facility deliveries. Claim submission is not proof that the prescription or fiscal order was actually furnished.

Provisions of this signature requirement at time of pick up include:

• The signature documentation must also include the prescription number and date the prescription/fiscal order was picked up. If multiple prescriptions are being picked up at one time, a single signature verifying receipt will be sufficient for all of the patient's prescriptions/fiscal orders.
• Electronic signatures for receipt are permitted only if retrievable upon audit and kept on file by the pharmacy.
• Obtaining a signature to confirm receipt of prescriptions/fiscal orders can be part of a counseling log.
• The signature confirmation must be maintained by the dispensing pharmacy for six years from the date of payment and must be retrievable upon audit.

Provisions of this signature requirement for facility delivery include:

• A signature is required at the time of delivery.
• The signature documentation must also include the list of prescription number(s) and date the medication(s) was/were delivered. A single signature verifying receipt will be sufficient for all of the medications in the delivery.
• Electronic signatures for receipt or electronic tracking slips for delivery are permitted only if retrievable on audit.
• A waiver signature form is not an acceptable practice, and such forms will not serve as confirmation of delivery. Waiver signature forms are defined by delivery industry standards.
• Confirmation of the delivery must be maintained by the pharmacy for six years from the date of payment and must be retrievable on audit. Delivery industry tracking receipts that contain a signature (e.g., FedEx tracking receipts) qualify as a signature for receipt of delivery.

For more information on the policy contact our pharmacy attorneys at 718-787-9500 or at This email address is being protected from spambots. You need JavaScript enabled to view it. .

To all Medicaid providers:

In accordance with new federal rules and regulations, the New York State Medicaid program will be rolling out the provider revalidation process.

Revalidation will include attestation of credentials as well as the agreement to abide by the rules and regulations of the Medicaid program. Certain provider types will be required to pay a fee for revalidation. A revalidation process will be initiated by the New York Department of Health in the fall of 2012.  Revalidation will be rolled out by provider type. Correspondence will be sent to providers, advising them of their need to revalidate their enrollment. Providers will then have 150 days from receipt of the notice to complete the process. Failure to comply with the revalidation and attestation within the timeframe will result in provider disenrollment.

Our firm will assist new and existing clients with Medicaid revalidation.  Further updates will be provided when they become available, including a preliminary list of required documentation.

Providers are reminded that they are obligated to complete a compliance package if they bill more than $500,000 to NY Medicaid program annually (including through third-party Medicaid HMOs).  We expect that one of the required documents for Medicaid revalidation will be a certification of compliance.  We will provide a 20% discount to all clients who retain our firm to prepare a compliance package within the next 30 days after the publication of this announcement (through March 3, 2012).  Please contact us as soon as possible if you do not have a compliance package in place as this might result in substantial penalties, puts you at a much higher risk of Medicaid audit, and will prevent you from revalidating your Medicaid enrollment.

Our client, a registered nurse, was charged with professional misconduct for allegedly falsifying prescriptions and using it for her own use.  Following an interview with the office of Professional Discipline and presentation of written and oral evidence, the investigation against our client was terminated with no consequences to our client.

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