July 17, 2008
Dear Medicaid Director:
This letter contains critically important information regarding compliance with the Medicaid Tamper Resistant Requirements.
As of October 1, 2008, the
second phase of the CMS tamper-resistant prescription law takes effect,
and will require that all handwritten and/or computer generated (by
an EMR or ePrescribing applications) printed prescriptions for fee-for-service
Medicaid patients be fully compliant with federal and/or state guidance
for prescription tamper resistance. While the first phase of tamper
resistance guidance required prescribers to use at least one feature
from one category of tamper resistance, this second phase requires that
these handwritten or computer printed Medicaid prescriptions contain
at least one industry recognized feature from each of the three
categories of tamper resistance. Prescriptions for Medicaid patients
that are telephoned, faxed, or ePrescribed remain exempt from these
tamper resistance requirements.
On June 26, 2008, the National
Council for Prescription Drug Programs (NCPDP) held an industry forum
in an effort to review the implementation of the 2nd phase of the CMS
tamper-resistant regulations and to discuss next steps necessary to
ensure a smooth transition into the second phase of implementation on
October 1. All segments of industry impacted by the Federal legislation
were invited and participated including State Medicaid pharmacy administrators,
National Association of State Medicaid Directors (NASMD), pharmacy associations,
medical associations, CMS, printers of tamper resistant pads/paper,
and the Physicians EHR Coalition and the EHR Vendors Association.
As a result of this meeting,
industry standards for copy, erasure/modification, and counterfeit resistance
have been clarified. If you issued specific guidance for your
state based on the prior guidelines please verify that your previously
issued guidelines do not require further revision.
Also, CMS had previously stated that prescriptions printed from EMRs or ePrescribing applications would likely need special copy resistant paper to be in compliance as of October 1, 2008. CMS is now clarifying that guidance, based on its awareness of improved printing capabilities, and is now stating that while special paper may be used to achieve copy resistance, it is not a requirement. EMR or ePrescribing generated prescriptions may be printed on plain paper and be fully compliant with all three categories of the tamper-resistant regulations provided they contain at least one feature from each of the three categories detailed below.
Currently, a handwritten or
computer generated prescription must contain a feature in at least one
of the following three characteristic categories to be compliant.
By October 1, 2008 handwritten or printed prescriptions must contain
a feature within all three categories. While the law specifies
the term prescription pad¯, CMS stated that these requirements
also apply to computer-generated prescriptions that are printed using
paper inserted into the printer. No one feature may be counted
twice.
For more information about
the tamper resistant requirements, visit www.cms.hhs.gov/
As determined by the industry
forum, the following best practices are strongly suggested for adoption
to meet the tamper-resistant requirements (See Appendix I for examples):
Best Practices for Tamper Resistant Printed Prescriptions | |||
Feature |
Description | ||
Category
1:
Copy Resistance |
A) Void/Illegal/Copy Pantograph with or without Reverse Rx B) Micro print signature line
for prescriptions generated by an EMR if they cannot produce Void/Illegal/Copy
Pantograph with or without Reverse Rx |
The word Void,¯ Illegal,¯ or Copy¯ appears when the prescription is photocopied. Very small font which is legible (readable) when viewed at 5x magnification or greater, and illegible when copied. | |
Category
2:
Erasure / Modification Resistance |
A) An Erasure revealing background (resists erasures and alterations) for written prescriptions or printed on toner-lock¯ paper for laser printed prescriptions, and on plain bond paper for inkjet printed prescriptions |
Background that consists of a solid color or consistent pattern that has been printed onto the paper. This will inhibit a forger from physically erasing written or printed information on a prescription form. Toner-lock paper is special
printer paper that establishes a strong bond between laser-printed text
and paper, making erasure obvious. Note
this is NOT necessary for inkjet printers
as the ink from inkjet printers is absorbed into normal
bond¯ paper. | |
B) Quantity check off boxes, refill indicator (circle number of refills or NR¯), or border characteristics (dispense and refill # bordered by asterisks and optionally spelled out) for prescriptions generated by an EMR | In addition
to the written quantity on the prescription, quantities are indicated
in ranges. Quantities and refill # are surrounded by special characters such as an asterisks to prevent modification, e.g. QTY **50**. | ||
Category 3:
Counterfeit Resistance |
A) Security features and descriptions listed on the prescription | A Complete list of the security features on the prescription paper aids pharmacists in identification of features and determine compliance. |
We strongly suggest that guidance
be released no later than August 15, 2008 in order to ensure
that physicians and pharmacies have ample time to prepare for the October
1 implementation date. CMS has determined that states listed below,
with the exception of Idaho, which had tamper-resistant prescription
programs in place prior to the passage of the law are all in compliance
with the October 1 deadline. Nevertheless, we are encouraging those
states to revisit their guidance, as it may be incorrect or irrelevant
for printed prescriptions from EMRs or ePrescribing applications.
For your reference, a copy of the standards for each of the following
states is attached as Appendix II.
California | Maine |
Florida | New Jersey |
Idaho1 | New York |
Indiana | Texas |
Kentucky | Wyoming |
Appendix III summarizes features
that could be used on a tamper-resistant prescription in compliance
with the CMS guidelines to meet the requirements for October 1.
They are categorized according to the three types of tamper-proof features
described by CMS. We would like to draw your attention to
the first feature that falls into the third CMS Category of Counterfeit
Resistance above. The pharmacy community, as represented by
the APhA, NACDS and NCPA strongly believe that while any feature in
this category would satisfy CMS requirements for counterfeit resistance,
that this listing of security features on every prescription should
be required because it ALSO greatly assists pharmacists in identifying
tamper resistant prescriptions, and thus should be a common feature
for all prescriptions that require tamper resistance.
NCPDP and the other members
of the industry forum encourage those states that have not issued guidance
for the October 1 implementation date to publish your requirements no
later than August 15, 2008 so that providers have sufficient
time to order fully compliant prescription pads, and that EMR and ePrescribing
vendors have sufficient time to modify their prescription templates
or prescription printing processes such that they are also fully
compliant with the October 1 deadline.
In addition to this guidance,
we have created a template letter for you to use when communicating
this information to your prescriber community. You are encouraged to
modify this letter with your state specific requirements.
If your have any additional
questions or concerns, please contact Michele Vilaret at mvilaret@nacds.org or Peter Basch at Peter.Basch@Medstar.net.
Respectfully,
Lee Ann Stember
President, NCPDP
cc:
American College of Physicians
American Pharmacists Association
Centers for Medicare & Medicaid Services
Computer Sciences Corporation
JenKare, LLC
HP Labs
LexMark International
Medical Group Management Association
MedStar Health
NASMD/APHSA
National Association of Chain Drug Stores
National Community Pharmacists Association
National Council for Prescription Drug Programs
NextGen Healthcare/EHRVA
North Carolina Medicaid
Promex Group- Medi Scripts Services
Rite Aid Corporation
Standard Register
SXC Health Solutions
Walmart Health & Wellness
Wyoming Department of Health
Appendix
1
Best Practices for Tamper
Resistant Printed Prescriptions (Handwritten)
Category 1
A) Photocopied COPY¯, ILLEGAL¯, or VOID¯ Pantograph
Category 2
A) An Erasure revealing background (resists erasures and alterations)
B) Quantity check off boxes
C) Refill indicator (circle number
of refills or NR¯)
Category 3
A) Security features and descriptions
listed on the prescription
Appendix
I (continued)
Best Practices
for Tamper Resistant Printed Prescriptions (Generated by an EMR)
Example A
Category #1 Copy Resistance:
Microprint signature line* Category #2 Modification
/ Erasure Resistance: Border characteristics (dispense and refill #
bordered by asterisks AND spelled out) Category #2 Modification
/ Erasure Resistance: Printed on toner-lock¯ paper Category #3 Counterfeit
Resistance: Listing of security features *Microprint Line viewed at
5x magnification THIS IS AN ORIGINAL
PRESCRIPTION-THIS IS AN ORIGINAL PRESCRIPTION-THIS IS AN ORIGINAL PRESCRIPTION-THIS
IS AN ORIGINAL PRESCRIPTION Example B Category #1 Void/Illegal/Copy
Pantograph with or without Reverse Rx Category #2 Modification
/ Erasure Resistance: Border characteristics (dispense and refill #
bordered by asterisks AND spelled out) Category #2 Modification
/ Erasure Resistance: Printed on toner-lock¯ paper Category #3 Counterfeit
Resistance: Listing of security features Appendix
II Tamper-Resistant
Prescription Pad Security Features Required by States Prior to April
1, 2008 Void¯ pantograph, security
prescription watermark, chemical void protection, area of opaque writing,
quantity check boxes with units, printed on security paper, security
back printing, listing of security features, thermo chromatic ink, batch
numbering, separate vendor ID, sequential numbering starting at 0001
at each new order.1 Void¯or Illegal¯
pantograph (green or blue), erasure safe paper, background ink that
resists reproduction, watermarked paper, security feature listing (face
or back), batch number which includes vendor ID, physicians license
verification required by vendor. State seal on face and back
for pantograph, Rx¯ graphic on face, blue face with black imprint,
green back, batch number which includes vendor ID, 8 standard formats,
pre-printed batch number, physicians license verification required by
vendor, shipment log by vendor, prescription blanks for each prescriber
or health care facility must be numbered consecutively. Void¯ Pantograph, erasure
protection on a colored background, security features listed, physician
license verification by vendor. 1
Appendix III Summary
features that could be used on a tamper-resistant pad/paper in
compliance with the CMS guidelines Some pantographs can be problematic
because when the prescription is copied, the resulting void¯ or
other wording that appears makes the underlying prescription difficult
to read. This type of pantograph should be avoided. We suggest that
you ask your pad vendor about hollow VOID¯ pantograph lettering
which is less likely to obscure the prescription information. The Reverse Rx disappears when
copied at a light setting thus making the pantograph more effective
in copy resistance. The pantograph may be paired with a reverse
Rx, but Reverse Rx is not effective as a feature by itself. Security back print (artificial
watermark) Digital watermarks Special paper watermarking Weak digital watermarks cannot
be read if copied and strong digital watermarks provide digital rights
management/proof¯ of origin when copied. Uses special paper containing
a watermark that can be seen when backlit. Appendix
III (continued) OR Chemically reactive paper (erasure
resistance for hand written prescriptions) If exposed to chemical solvents,
oxidants, acids, or alkalis that can be used to alter the prescription,
the chemically reactive paper will react and leave a mark visible to
the pharmacist. The refill indicator indicates
the number of refills on the prescription. Refill numbers must
be used to be a valid prescription. Example: Rx is void if more
than XXX Rxs on paper¯ Please note that while ONLY
one feature from this Category 2 is required, it is strongly recommended
that one feature of erasure resistance and one feature of modification
resistance be used. Inkjet printed prescriptions are de-facto
erasure resistant based on the characteristics of inkjet ink. Appendix
III (continued)
Appendix I (continued)
State
Security Features California
Prescription pads must be
printed from approved vendors only.1
Florida
Prescription pads must be
printed from approved vendors only.
Idaho2
Non-copyable paper ONLY1 Indiana
Void¯ pantograph (blue),
Security Back print, quantity check boxes, refill quantity and void
after¯ wording, one prescription per form, dispense as written/may
substitute wording.1 Kentucky
Void¯ pantograph (green),
Security Back print, quantity check boxes, refill quantity and void
after¯ wording, one prescription per form, dispense as written/may
substitute wording. 1 Maine
Void¯ pantograph, repetitive
watermark on backside, thermo chromatic ink, list of security features.
1 New Jersey
Prescription pads must be
printed from approved vendors only.
New York
Void¯ pantograph, thermo
chromatic ink, diagonal lines, micro fine printing, serial number and
bar code. Texas
Void pantograph, thermo
chromatic ink, erasure safety paper, security features listed, control
number. West Virginia
Void¯ pantograph (green),
Security Back print, quantity check boxes, refill quantity and void
after¯ wording, one prescription per form, dispense as written/may
substitute wording. 1 Wyoming
Prescription pads must be
printed from approved vendors only. 1
Category 1
Copy Resistance: One or more industry recognized features designed
to prevent unauthorized copying of a completed or blank prescription
form.
Feature
Description
Void,¯ Illegal,¯ or Copy¯ pantograph with or without
Reverse Rx¯
The word Void,¯
Illegal,¯ or Copy¯ appears when the prescription is photocopied.
Except where state law mandates the word Void¯ or Illegal¯
it is recommended that the pantograph show the word Copy¯ if
the prescription is copied. The pantograph should be configured
so as not to obscure the security feature description contained on the
prescription, the patient and prescriber demographics, or the medication
and directions.
Micro
printing To be effective this feature must be printed in 0.5 font or
less making it illegible to the pharmacist when copied
Very small font
which is legible (readable) when viewed at 5x magnification or greater,
and illegible when copied. Thermochromic
ink
Ink changes color
with temperature change. Coin-Reactive
Ink
Ink changes color
when rubbed by a coin. Watermarking
Printed
on the back of prescription form. The most popular wording for
the security back print is Security Prescription¯ or the security
back print can include the states name. Can only be seen when viewed
at an angle.
Category 2
Erasure / Modification Resistance:
One or more industry-recognized features designed to prevent the erasure
or modification of information written / printed on the prescription
by the prescriber. Features
to Prevent Erasure
Description An
erasure revealing background (erasure resistance)
Background that
consists of a solid color or consistent pattern that has been printed
onto the paper. This will inhibit a forger from physically erasing
written or printed information on a prescription form. If someone
tries to erase, the consistent background color will look altered and
show the color of the underlying paper. Toner
Receptor Coating / Toner Lock or Color Lock paper (erasure resistance
for computer generated prescriptions printed with a laser printer)
Special printer
paper that establishes a strong bond between laser-printed text and
paper, making erasure obvious. Note this is NOT necessary
for inkjet printers as the ink from inkjet printers is absorbed
into normal bond¯ paper.
Features
to Prevent Modification
Description Quantity
check off boxes and refill indicator (circle or check number of refills
or NR)
In addition to
the written quantity on the prescription, quantities are indicated in
ranges. It is recommended that ranges be 25s with the highest
being 151 and over¯. The range box corresponding to the quantity
prescribed MUST be checked for the prescription to be valid.
Pre-printed
language on prescription paper
Reduces ability
to add medications to the prescription. Line must be completed
for this feature to be valid. Computer printer paper can accommodate
this feature by printing, This space intentionally left blank¯
in an empty space or quadrant. Quantity
and Refill Border and Fill (this is the recommended for computer generated
prescriptions)
Quantities and
refill # are surrounded by special characters such as an asterisks to
prevent modification, e.g. QTY **50** Value may also be expressed as
text, e.g. (FIFTY), (optional).
Category 3
Counterfeit Resistance: One or more industry-recognized feature
designed to prevent the use of counterfeit prescription forms. Feature
Description Security
features and descriptions listed on prescriptions this feature is
strongly recommended on all prescriptions
Complete list
of the security features on the prescription paper for compliance purposes.
This is strongly recommended to aid pharmacists in identification of
features implemented on prescription. Thermochromic
ink
Ink changes color
with temperature change. State
Approved Vendor ID
This feature is
only effective in states with an approved vendor listing. Serial
number
Number issued
by printer of prescription or uniquely assigned by EMR or ePrescribing
software; may or may not be sequential. Only valid if reported
and tied to the pharmacy claim adjudication process. NY is the only
state that has this system currently in place. Encoding
techniques (bar codes)
Bar codes on prescription.
Serial number or Batch number is encoded in a bar code. Security
thread
Metal or plastic
security threads embedded in paper as used in currency.