DEA Rule Change on Multiple Rx's

IMPORTANT DEA RULE CHANGE NOTICE!!!
Please post in pharmacy(pdf.).
Effective December 19th, 2007, the Drug Enforcement Administration (DEA) is finalizing a Notice of Proposed Rulemaking that was published on September 6, 2006. This proposed amendment allows practitioners to provide patients with multiple prescriptions, to be filled sequentially, for the same schedule II medication, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of a schedule II medication.

§1306.12 Refilling prescriptions; Issuance of multiple prescriptions.
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b) (1) 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:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii) 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;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) 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.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.

§1306.14 Labeling of substances and filling of prescriptions.
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.

*taken from Federal Register/ Vol.72, no. 222 pgs. 64921-64930 on 11/24/07 published November 19th, 2007.

**Special thanks to Lee Ann Bradley, Pharm.D., BCPS for awareness on this issue.**

**Full 10 page pdf. of Federal Register on Issuance of Multiple Prescriptions including comments and discussions**

FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Telephone (202) 307–7297.

Tamper-Resistant Prescription Pad Notice!!!

Montana Medicaid Notice
Physicians, Mid-Level Providers, Dentists,
Pharmacies, and Inpatient and Outpatient Hospitals
Tamper-Resistant Prescription Pads — UPDATED

The Centers for Medicare and Medicaid Services (CMS) released guidance to state Medicaid programs regarding a new law requiring the use of Tamper-Resistant Prescription Pads. Beginning October 1, 2007, all written Medicaid prescriptions must be on Tamper-Resistant prescription pads. This requirement applies to all outpatient drugs, including over-the-counter medications, regardless of whether Medicaid is the primary or secondary payor. Prescriptions may still be telephoned, faxed, or transmitted electronically (e-prescribed) to pharmacies as allowed by current federal and state regulations.

Initial Department guidance issued September 7th proposed the use of indelible ink in an alphanumeric format. Though the Department determined this met the intent of the law, CMS issued an additional Frequently Asked Questions (FAQ) document which stated this practice was not acceptable.

CMS provided further guidance that written orders prepared in an institutional setting where the patient never has the opportunity to handle the written orders are considered “tamper resistant.” The CMS guidance and FAQ documents are posted at the Department’s web-site: http://medicaidprovider.hhs.mt.gov/pdf/trpfaqs.pdf

The Tamper Resistant Pad requirement does not apply to drugs which are “bundled” or not separately reimbursed in conjunction with services provided in nursing facilities, intermediate care facilities, and other specified institutional and clinical settings as described by 42 USC 1927 (k)(3) http://www.ssa.gov/OP_Home/ssact/title19/1927.html.
This requirement does not apply to refills of prescriptions written before October 1, 2007.

Requirements and Guidance
Montana Medicaid encourages prescribers to telephone, fax or electronically transmit prescriptions to pharmacies.

Beginning October 1, 2007, CMS will require that a Medicaid prescription pad shall contain one of the following three characteristics:

1. One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;
2. One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber, and
3. One or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

Beginning October 1, 2008, a written Medicaid prescription must contain all three characteristics.

Pharmacies may fill the full prescription of covered outpatient drugs written on non-compliant prescription pads, or a portion thereof at the pharmacist’s discretion. However, pharmacies must verbally confirm the non-compliant prescription and document the call on the face of the prescription, or obtain a faxed, electronic, or compliant written prescription within 72 hours of the date the prescription was filled.

The Department is compiling a list of vendors which can produce compliant pads. This list shall be posted on the DPHHS web page and updated regularly as new vendors are identified. This list is not exclusive and prescribers may contact the Department to confirm the acceptability of their tamper resistant pad.

Schedule II (CII) Drugs
Schedule II prescriptions must be in writing to comply with DEA and Montana Board of Pharmacy regulations specified in ARM 24.174.523. While pharmacies cannot fill faxed or verbal CII prescriptions, prescribers can use these methods to provide confirmation to pharmacies. In accordance with CMS guidance, faxed or verbal confirmation will render the CII prescription, written on non-tamper resistant paper, compliant.

Enforcement
Currently, the Federal law and CMS guidelines apply only to Medicaid clients’ prescriptions. It will be essential to identify any Medicaid eligibility at the time the prescriptions are written and/ or filled to ensure that those prescriptions comply with the applicable rules. CMS requires the States to enforce the tamper resistant pad requirement. The Department is developing audit procedures to ensure compliance.

Verifying Client Eligibility
There are several eligibility verification methods available using the client member number/card control number printing on the Montana Access to Health Card.

• Web Portal: https://mtaccesstohealth.acs-shc.com/mt/general/home.do will provide
online eligibility information. Registration as a provider is necessary.
• FAXBACK 800-714-0075: Returns a copy of the client’s eligibility when given the client’s identification number, via fax to the provider within a couple of minutes after ending the call. Please make sure your fax number is on record with ACS to use this free service.
• AVRS (Automated Voice Response System) 800-714-0060: Provides the client’s eligibility
and billable identification number through an automated voice system.
• Provider Relations Department 800-624-3958 (in-state) 406-442-1837 (Helena and outof- state): Verify eligibility with Provider Relations Monday-Friday from 8 am to 5 pm.
Please direct any questions regarding this notice to the following personnel: Physician and Mid-Level providers: Denise Brunett at (406) 444-5778; Dentists: Jan Paulsen at (406) 444-3182;
Pharmacy providers: Wendy Blackwood at (406) 444-2738; Hospitals: Debra Stipcich at (406) 444-4834.

Contact Information
For claims questions or additional information, contact Provider Relations:
Provider Relations toll-free in- and out-of-state: 1-800-624-3958
Helena: (406) 442-1837
Visit the Provider Information website:
http://www.mtmedicaid.org/

Please go to In the Spotlight for a list of Vendors for Tamper-Resistant Prescription pads

A few words from Roger Citron, R.Ph., DPHHS

The following is a message from Roger Citron, RPh, DPHHS:

"We are currently working to identify vendors capable of providing script pads which will be fully 2008 compliant, but as of 10/1/2007 one of the three "industry recognized standards" or documentation of verbal confirmation by the prescriber documented on the face of the prescription must be incorporated on written Medicaid scripts to ensure reimbursement by the State. I agree that it is unfortunate that pharmacies bear the brunt of the legislation, when it is incumbent upon the prescriber to comply, but that is the way the law is written and once again pharmacies are the easy target to ensure compliance.

I cannot stress enough the importance of pharmacies working with prescribers to fax or call in scripts, or come up with other creative methods to ensure compliance. Our Prudent Audits will be required to look for compliance, so when a prescription is audited after 10/1/2007 pharmacies need to ensure it is compliant with the new law to avoid recoupment. Unfortunately the clients will ultimately be impacted as they are turned away by some pharmacies unwilling to assume the risk or unwilling to call for verification."

Roger A. Citron, R.Ph.
Montana DPHHS

Thank you Roger for your guidence during these critical times!

Updated News!!!

Please visit the MT Pharmacist "Main Page" for updated material on Actos, Avandia, Pain Awareness Month, and the New Prescription Pad requirements from Montana Medicaid. Please Click Here.

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