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INSTRUCTIONS FOR OP FORMS

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Title of Rule: Tamper-Resistant Prescription Drug Pads
Rule Number: MSB 08-08-05-A
Division / Contact / Phone: Pharmacy Benefits Section / Kerri Coffey / 303-866-4131

 

SECRETARY OF STATE

RULES ACTION SUMMARY AND FILING INSTRUCTIONS 

SUMMARY OF ACTION ON RULE(S) 


1. Department / Agency Name: Health Care Policy and Financing / Medical Services Board
2. Title of Rule: MSB 08-08-05-A, Tamper-Resistant Prescription Drug Pads
3. This action is an adoption of: an amendment
    4. Rule sections affected in this action (if existing rule, also give Code of Regulations number and page numbers affected):
    Sections(s) 8.837.2, Colorado Department of Health Care Policy and Financing, Staff Manual Volume 8, Medical Assistance (10 CCR 2505-10).
5. Does this action involve any temporary or emergency rule(s)? Yes
    If yes, state effective date:
 
    Is rule to be made permanent? (If yes, please attach notice of hearing).
Yes

 

PUBLICATION INSTRUCTIONS*

Please replace the current text beginning at ��8.837 through ��8.837.3.D with the new text attached. This change is effective October 1, 2008. 

 


Title of Rule: Tamper-Resistant Prescription Drug Pads
Rule Number: MSB 08-08-05-A
Division / Contact / Phone: Pharmacy Benefits Section / Kerri Coffey / 303-866-4131

STATEMENT OF BASIS AND PURPOSE

 
    1. Summary of the basis and purpose for the rule or rule change.  (State what the rule says or does and explain why the rule or rule change is necessary).
    The purpose of this rule revision is to clarify the features that make pads tamper-resistant, pursuant to guidance recently posted by the Centers for Medicare and Medicaid Services. 
    2. An emergency rule-making is imperatively necessary
    to comply with state or federal regulation and/or
    for the preservation of public health, safety and welfare.
    Explain:
    Federal law requires that states not make payment for amounts expended for medical assistance for covered outpatient drugs unless the prescription is executed on a tamper-resistant pad.
    3. Federal authority for the Rule, if any:
    42 U.S.C. Section 1396b(i)(23)
    4. State Authority for the Rule:
    25.5-1-301 through 25.5-1-303, C.R.S. (2007);

    25.5-5-202, C.R.S. (2007)

 


Title of Rule: Tamper-Resistant Prescription Drug Pads
Rule Number: MSB 08-08-05-A
Division / Contact / Phone: Pharmacy Benefits Section / Kerri Coffey / 303-866-4131

REGULATORY ANALYSIS

 

    1. Describe the classes of persons who will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule.

    Pharmacies and prescribers enrolled as Medicaid providers will be affected by the proposed rule revision.

    2. To the extent practicable, describe the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons.

    Prescribers will be required to write prescriptions for covered outpatient drugs on tamper-resistant pads.  The cost of these pads will be borne by the prescribers, though in some cases prescribers may already utilize pads that comply with the rule.  Also, prescribers may send prescriptions electronically (via the internet), by fax or by telephone to eliminate the need for tamper resistant prescriptions entirely.  Given these variables, the Department does not have data to quantify the economic impact of this rule on prescribers.  Pharmacies will be required to accept written prescriptions for Medicaid clients on tamper resistant pads only.  Pharmacies may incur administrative costs in order to assure compliance with this requirement but the Department does not have data to quantify the costs.

    3. Discuss the probable costs to the Department and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues.

    The Department does not anticipate any implementation costs and expects that existing Department staff are sufficient to enforce the proposed rule revision.

    4. Compare the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction.

    Inaction is not an option because the use of tamper-resistant prescription pads is required by the Social Security Act.

    5. Determine whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule.

    N/A

    6. Describe any alternative methods for achieving the purpose for the proposed rule that were seriously considered by the Department and the reasons why they were rejected in favor of the proposed rule.

    N/A

 

    8.837 PRESCRIPTION REQUIREMENTS

    8.837.1 REIMBURSEMENT

    8.837.1.A. Reimbursement shall be made for prescribed drugs provided to eligible recipients when the following conditions are met:

      1. The item dispensed is a covered prescription drug by a participating company, a compounded prescription as described in 10 C.C.R. 2505-10, Section 8.832, or has been prior authorized;

      2. The person prescribing the item is authorized to do so by appropriate Colorado statutes;

      3. The prescription is dispensed in accordance with applicable federal and state laws, rules, and regulations;

      4. The prescription is dispensed in accordance with the law, rules, and regulations governing the Colorado Medical Assistance Program; and

      5. The prescription is written on a tamper-resistant prescription drug pad or is excluded from the tamper-resistant prescription drug pad requirements set forth in 10 C.C.R. 2505-10, Section 8.837.2.

    8.837.2 TAMPER-RESISTANT PRESCRIPTION DRUG PADS OR PAPER

    8.837.2.A. The use of tamper-resistant prescription drug pads or paper is required for all written or electronically printed prescriptions for all Medical Assistance Program clients when:

      1. Prescriptions are issued for outpatient drugs, including controlled and uncontrolled substances, or OTC drugs that are reimbursable through the Medical Assistance Program and dispensed by a pharmacy; and

      2. The Medical Assistance Program is the primary or secondary payor of the prescription being filled.

    8.837.2.B. To be considered tamper-resistant, the paper used for a written or electronically printed prescription shall integrate three distinct characteristics.   The three characteristics and the specific features required are as follows:

      1. Characteristic #1:  One or more industry-recognized features designed to prevent unauthorized copying of completed or blank prescription form.  A prescription shall contain at least one of the following features:

        a. Void/Illegal/Copy Pantograph with or without the Reverse Rx feature.  The word ��Void��, ��Illegal��, or ��Copy�� appears when the prescription is photocopied.  If the paper has the Reverse Rx feature, the Rx symbol must disappear when photocopied at light setting.  The Reverse Rx feature is not allowed as a feature by itself.

        b. Micro-fine printed security message generated by a computer, electronic medical records system or other electronic means.  The message may serve as a signature line or border.  This must be printed in 0.5 font or smaller and readable when viewed at 5x magnification or greater and illegible when copied. 

        c. Coin-reactive ink or security mark.  The pad or paper identifies an area on the pad/paper where the ink changes color or reveals wording or a picture when that area is rubbed by a coin.  This must be accompanied by a message describing what is necessary to demonstrate authenticity.

        d. Security print watermark.  Specific wording is printed on the front or back of the prescription paper and can only be seen when viewed at an angle. 

        e. Paper with a watermark.  This is paper that contains a watermark that can be seen when backlit.

      2. Characteristic #2:  One or more industry recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber.  A prescription shall contain at least one of the following features:

        a. An erasure-revealing background.  This is a background that consists of a non-white solid color or consistent pattern that has been printed onto the paper.  If an erasure or modification is attempted, the background will show marks or the color of the underlying paper where the alterations were made.

        b. Toner fusing technology for laser-printed prescriptions.  This is a treatment that is added to the surface of the paper to create a strong bond between the laser-printed text and the paper.  The computer-printed information cannot be lifted from the surface of the paper without damaging the paper.

        c. Chemical-reactive paper.  This is paper that contains features that show discoloration or reveals a hidden message if solvents are used to attempt to wash the ink from its surface.

        d. Plain bond paper combined with inkjet-printing.  The inkjet printing is absorbed into the high grade paper stock.  Erasures and modifications cannot be made without damaging the paper.

        e. Pre-printed quantity check-off boxes indicated in ranges of no more than 25 per range combined with a written quantity.  The range box corresponding to the quantity prescribed must be checked by the prescriber for the prescription to be valid.

        f. Pre-printed refill indicator where the number of refills allowed is marked or no refills or ��NR�� is marked when no refills are authorized.  Refill information must be completed by the prescriber for the prescription to be valid.

        g. Characters surrounding the authorized dispensing quantity and the number of refills.  Special characters such as a series of asterisks must be repeated on both sides of the numbers indicating the quantity and the number of refills authorized, e.g., Quantity ***50***  Refill ***3***.  This is acceptable only for prescriptions that are generated by a computer, electronic medical records system or other electronic means. 

      3. Characteristic #3:  One or more industry recognized features designed to prevent the use of counterfeit forms.  A prescription must contain at least one of the following features:

        a. Security features listed visibly in a box, band or border on the prescription.  This must be a complete listing of all of the security features incorporated into the prescription pad/paper in order to minimize tampering.

        b. Security threads.  Metal, fluorescent or plastic security threads are embedded into the prescription pad/paper. 

        c. Thermochromic ink.  All or some of the pad is pre-printed with ink that changes color when exposed to heat and then changes back to its original color when cooled.  This must be accompanied by a message describing what is necessary to demonstrate authenticity. 

    8.837.2.C. The use of tamper-resistant prescription pads is not required when:

      1. Prescriptions are transmitted by telephone, fax or electronic-prescription (e-prescription) directly to the pharmacy by the prescriber or prescriber��s staff that is authorized to act on the prescriber��s behalf; or

      2. A prescriber administers or provides the drug directly to the patient; or

      3. A prescriber in an institutional setting writes the order into the medical record and then the order is given by medical staff directly to the pharmacy; or

      4. A Medical Assistance Program managed care entity pays for or dispenses the prescription; or

      5. A prescription is written for any medical item, service or equipment that is not considered an outpatient drug.

    8.837.2.D. The use of tamper-resistant prescription drug pads or paper does not apply to drugs that are provided as part of the following:

      1. Inpatient hospital services;

      2. Hospice services;

      3. Dental services (except when a State Plan authorizes direct reimbursement to the dispensing dentist);

      4. Physician services;

      5. Outpatient hospital services;

      6. Nursing facilities and intermediate care facilities for the mentally retarded;

      7. Other laboratory and x-ray services; or

      8. Renal dialysis.

    8.837.2.E. The pharmacy may dispense up to a 72-hour supply of a covered outpatient prescription drug in an emergency situation, provided that the pharmacy obtains a compliant prescription in writing, or by telephone, facsimile, or e-prescription, within 72 hours of filling the prescription.

    8.837.2.F. When a Medical Assistance Program client is determined retroactively eligible after a pharmacy has filled the recipient��s prescription, the prescription shall be deemed to comply with the tamper-resistant pad requirements.  This presumption applies only to prescriptions that were filled before the client was determined eligible.  Prescriptions that are filled or refilled after the client is determined eligible require a new, tamper-resistant prescription or the pharmacy may obtain verbal confirmation of the prescription from the prescriber or may obtain the prescription from the prescriber by facsimile or e-prescription.

    8.837.3 RECORD RETENTION

    8.837.3.A. Participating pharmacy providers must maintain the original copy of all prescriptions for which payment from the Medical Assistance Program is requested. The original prescription shall be a hard copy either written by the prescriber or reduced to writing when received by the pharmacist by telephone or other electronic means. Information required by the Colorado State Board of Pharmacy shall be recorded on each prescription but must include, name of patient, name of drug, quantity ordered, directions, name of prescribing practitioner, date written and date filled, and initials of pharmacist filling the prescription or responsible for its contents.

    8.837.3.B. In addition, if a substitution for a prescribed brand name drug is made or the prescription is written generically, the name and manufacturer of the drug dispensed shall be recorded on the face of the prescription. A copy of a label which is created to accompany the drug will not suffice as the prescription.

    8.837.2.C. Any refill prescription records shall be maintained in accordance with Colorado State Board of Pharmacy requirements and contain the same information as required above.

    8.837.3.D. Such files and records shall be maintained in an orderly manner and shall promptly be available for inspection by authorized personnel of the Colorado State Department of Health Care Policy and Financing, the U. S. Department of Health and Human Services, and the Colorado Medicaid Fraud Control Unit. 

*to be completed by MSB Board Coordinator

Initial Review   Final Adoption 10/10/2008
Proposed Effective Date 10/01/2008 Emergency Adoption 09/12/2008

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