Re: Implementation of the Federal Tamper-Resistant Prescription Pad Mandate

Transcription

1 January 2, 2008 Ms. Carol Herrmann-Steckel Commissioner Alabama Medicaid Agency PO Box Dexter Avenue Montgomery, AL Re: Implementation of the Federal Tamper-Resistant Prescription Pad Mandate Dear Ms. Herrmann-Steckel: The undersigned 90 pharmacy and medical organizations are writing to request that additional guidance be provided by your agency to prescribers, pharmacies, and Medicaid beneficiaries in your state regarding compliance with the federal statute requiring the use of tamper-resistant prescription pads (TRPPs) under Medicaid. 1 We are concerned that in the absence of additional guidance, members of the state s vulnerable Medicaid population could find themselves at risk of having medications delayed for hours or days, or even denied. Specifically, we are asking that you issue a detailed guidance that would clearly identify compliant prescription forms distributed in the state and state-specific implementation issues governing prescriptions covered by the mandate. We also request that you consult the state and local medical and pharmacy associations in your state to determine the feasibility and desirability of eliminating the federally suggested six-month phase-in period. Finally, we urge that you work with the undersigned organizations and the pharmacy and medical associations in your state in developing prescriber, pharmacy and pharmacist, and beneficiary outreach and education about the TRPP mandate and its implementation. Background The statutory provision mandating TRPP use was enacted on May 25, 2007, and because it was originally to take effect on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) was hard-pressed to draft a timely State Medicaid Directors guidance on its implementation before the scheduled effective date. State Medicaid Director Letter #07-012, providing CMS s expectations on how states would enforce the TRPP mandate, was published on August 17, This left your program and others little time to develop detailed implementation plans for inclusion in notices to providers, and little time to conduct extensive outreach to prescribers, pharmacies, and beneficiaries regarding the mandate. Many states only had time to forward to providers the broad outlines of the CMS guidance. CMS original guidance allowed states to phase in the requirement over a year s time. For the first year, a prescription pad would have had to contain at least one of the following characteristics: (1) at least one industry-recognized feature designed to prevent unauthorized copying, (2) at least one industry recognized feature designed to prevent erasure or modification, and (3) at least one industry recognized feature designed to prevent counterfeiting. In the second and final phase, not later than October 1, 2008, a prescription pad would have been required to meet all three characteristics. On September 29, 2007, two days before the mandate was to take effect, President Bush signed P.L , delaying the effective date for tamper-resistant prescription pads by six months, to April 1, Following the signing of the legislation, CMS stated in a list-serve message to affected stakeholders that, despite the (b) of the U.S. Troop Readiness, Veterans Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007.

2 month initial implementation delay, all pads would still be required to have all three of the required characteristics by October 1, Greater Detail Needed in Describing Compliant Pads The notices forwarded by many states to prescribers and pharmacies provided little additional detail beyond the broad requirements of SMDL #07-012, leaving it to those providers to determine which pads meet the federal guidelines. We believe that far greater detail needs to be provided to enable prescribers and pharmacists to identify compliant pads. CMS chose not to endorse a list of TRPP manufacturers out of a concern that the publication of such a list would be considered an endorsement of the manufacturers included, and because each state is best able to ascertain which manufacturers have an existing relationship and level of trade with prescribers in that state. However, we believe it is essential to ensuring compliance that your agency post on its website or forward to Medicaid prescribers and pharmacies a list of TRPP manufacturers serving the state that produce prescription forms known to comply with the statutory mandate. Such a list should include the manufacturer s catalogue (or other identifying) numbers for compliant forms. Maryland and California have already compiled lists of TRPP manufacturers serving their respective states and these can serve as best practice examples. Also, attached to this correspondence is a non-state-specific list of manufacturers we have compiled that can be used to develop state lists; we are prepared to help you further modify and maintain this or any other list you may compile. In addition, the National Council for Prescription Drug Programs (NCPDP) will be working over the next few months to develop a white paper with input from manufacturers, medical association representatives, pharmacy associations, and Medicaid program representatives that outlines which prescription pad characteristics are deemed compliant with the CMS guidelines. It is expected that the manufacturers will want to indicate on their prescription forms that their products comply with the NCPDP guidelines, and this should facilitate state Medicaid program identification. We ask that you join with us in urging the pad manufacturers to conform their forms to these standards labeling their forms as NCPDP-compliant once the standards have been published. We also want to remind you that CMS previously stated it is willing to provide an administrative funding match to states that choose to adopt and distribute an official prescription form that is compliant with the TRPP mandate. We ask you to consider the cost advantages of doing so; the savings in reduced fraud and abuse are likely to offset the state s portion of the costs of adopting and distributing an official form. In considering whether to adopt an official form or compile an informational list of compliant pads, we suggest that you consider the likely alternative scenario: Pharmacists, unable to determine whether the prescription form they hold is compliant, will likely call the Medicaid-participating prescriber for confirmation of the prescription, as permitted under SMDL # This will provide an additional administrative burden for each prescriber and pharmacist, and will likely delay the dispensing of crucial medications to Medicaid beneficiaries. In extreme cases where pharmacies are unable to reach the prescribing provider within the emergency fill period, beneficiaries could be denied their medications for an extended time. We believe that providing greater clarity to prescribers and pharmacies through a detailed guidance on which TRPPs meet compliance standards would help avoid these potential difficulties. Identification of State-Specific Implementation Issues We also ask that you inform prescribers and pharmacies in your state if you will be taking approaches to implementation that vary from those mandated and authorized under the broader CMS guidance either in requiring pads for additional Medicaid populations, such as for the managed care population, or in requiring pads under additional circumstances, such as for refills of prescriptions written prior to April 1. Other

3 specific issues addressed in the state guidance should include: (1) What the state limitation will be on the duration of the emergency supply filled while verbal authorization is sought by the pharmacy from the prescriber, and what subsequent documentation will be required of that verbal authorization. (2) Whether prescribers will be limited in the number of tamper-resistant pads they can possess on hand at any one time in order to guard against theft. (3) The mechanisms and procedures established for acceptance of pads authorized and utilized by prescribers in adjoining and snowbird states, and how updates will be communicated. (4) If you are one of the handful of states that implemented mandatory prescription pad requirements for some but not all Medicaid drugs prior to the federal implementation date, how that existing requirement will be expanded or modified to comply with the federal mandate. Elimination of Implementation Phase-In Period If a method can be devised for clearly and unambiguously indicating to prescribers and pharmacists that a prescription form is compliant, we suggest that you meet with the state and local medical and pharmacy associations operating in your state to discuss whether to require that all three conditions be met on April 1, 2008, rather than six months following implementation. Both prescribers and pharmacies should be willing to support elimination of the transition period because it will likely be easier for them to comply with one set of standards within a six-month period rather than two sets. However, a meeting of your Department with prescribers and pharmacies in the state will ensure that there is a consensus that an April 1, 2008 full implementation is practical, feasible, and desirable. If full compliance is to be required on April 1, we strongly suggest that your state consider a 60-day moratorium on audits for compliance with the mandate to give prescribers and pharmacists the time to grow comfortable with the requirement, the handling of the prescription pads, and procedures for obtaining and documenting verbal authorizations. Education of Prescribers, Pharmacists, and Beneficiaries Finally, the short time frame for implementation initially made formal outreach to and training and education of prescribers, pharmacists, and affected beneficiaries difficult. That time frame has now been extended, and we urge you to schedule outreach on this new mandate to and training of all affected persons. Prescribers and pharmacies will need to be made aware of the details of how the mandate will be implemented in your state and how qualifying pads will be identified. In addition, Medicaid beneficiaries will need to be informed perhaps through a Frequently Asked Questions (FAQ) information card that changes in federal law governing how their prescriptions may be written could, at least initially, lead to a delay in how quickly they may receive their medications. The signatories below all volunteer to work with state programs in developing the necessary outreach, training, and educational programs and materials to help assure prescriber and pharmacy compliance. The undersigned advocacy organizations are prepared to help with outreach to affected beneficiaries. If you have any questions regarding this correspondence, please contact Stuart Yael Gordon, Director of Public Policy, National Association of Chain Drug Stores, at sgordon@nacds.org or Thank you for your attention to this very crucial issue.

4 Sincerely, National Association of Chain Drug Stores National Community Pharmacists Association American Pharmacists Association National Alliance of State Pharmacy Associations Food Marketing Institute National Association of Community Health Centers Alaska Pharmacists Association Arkansas Pharmacists Association Arizona Pharmacy Alliance California Pharmacists Association Colorado Pharmacists Society Connecticut Pharmacists Association Delaware Pharmacists Society Florida Pharmacy Association Georgia Pharmacy Association Illinois Pharmacists Association Indiana Pharmacists Alliance Iowa Pharmacy Association Kansas Pharmacists Association Kentucky Pharmacists Association Maryland Pharmacists Association Massachusetts Pharmacists Association Michigan Pharmacists Association Minnesota Pharmacists Association Mississippi Pharmacists Association Missouri Pharmacists Association Nebraska Pharmacists Association New Hampshire Pharmacists Association New Mexico Pharmacists Association Pharmacists Society of the State of New York North Carolina Association of Pharmacists North Dakota Pharmacists Association Ohio Pharmacists Association Oklahoma Pharmacists Association Pennsylvania Pharmacists Association Rhode Island Pharmacists Association South Carolina Pharmacy Association South Dakota Pharmacists Association Texas Pharmacy Association Utah Pharmacists Association Vermont Pharmacists Association Virginia Pharmacists Association Washington State Pharmacy Association West Virginia Pharmacists Association Pharmacy Society of Wisconsin Wyoming Pharmacy Association American Medical Association American College of Physicians American Academy of Family Physicians American College of Obstetricians and Gynecologists American Academy of Pediatrics American Psychological Association Medical Group Management Association Alaska State Medical Association California Medical Association Connecticut State Medical Society Medical Society of Delaware Medical Society of the District of Columbia Florida Medical Association,

5 January 2, 2008 Mr. Jerry Fuller Medicaid Director AK Department of Health and Social Services PO Box Juneau, AK Re: Implementation of the Federal Tamper-Resistant Prescription Pad Mandate Dear Mr. Fuller: The undersigned 90 pharmacy and medical organizations are writing to request that additional guidance be provided by your agency to prescribers, pharmacies, and Medicaid beneficiaries in your state regarding compliance with the federal statute requiring the use of tamper-resistant prescription pads (TRPPs) under Medicaid. 2 We are concerned that in the absence of additional guidance, members of the state s vulnerable Medicaid population could find themselves at risk of having medications delayed for hours or days, or even denied. Specifically, we are asking that you issue a detailed guidance that would clearly identify compliant prescription forms distributed in the state and state-specific implementation issues governing prescriptions covered by the mandate. We also request that you consult the state and local medical and pharmacy associations in your state to determine the feasibility and desirability of eliminating the federally suggested six-month phase-in period. Finally, we urge that you work with the undersigned organizations and the pharmacy and medical associations in your state in developing prescriber, pharmacy and pharmacist, and beneficiary outreach and education about the TRPP mandate and its implementation. Background The statutory provision mandating TRPP use was enacted on May 25, 2007, and because it was originally to take effect on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) was hard-pressed to draft a timely State Medicaid Directors guidance on its implementation before the scheduled effective date. State Medicaid Director Letter #07-012, providing CMS s expectations on how states would enforce the TRPP mandate, was published on August 17, This left your program and others little time to develop detailed implementation plans for inclusion in notices to providers, and little time to conduct extensive outreach to prescribers, pharmacies, and beneficiaries regarding the mandate. Many states only had time to forward to providers the broad outlines of the CMS guidance. CMS original guidance allowed states to phase in the requirement over a year s time. For the first year, a prescription pad would have had to contain at least one of the following characteristics: (1) at least one industry-recognized feature designed to prevent unauthorized copying, (2) at least one industry recognized feature designed to prevent erasure or modification, and (3) at least one industry recognized feature designed to prevent counterfeiting. In the second and final phase, not later than October 1, 2008, a prescription pad would have been required to meet all three characteristics. On September 29, 2007, two days before the mandate was to take effect, President Bush signed P.L , delaying the effective date for tamper-resistant prescription pads by six months, to April 1, Following the signing of the legislation, CMS stated in a list-serve message to affected stakeholders that, despite the (b) of the U.S. Troop Readiness, Veterans Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007.

6 month initial implementation delay, all pads would still be required to have all three of the required characteristics by October 1, Greater Detail Needed in Describing Compliant Pads The notices forwarded by many states to prescribers and pharmacies provided little additional detail beyond the broad requirements of SMDL #07-012, leaving it to those providers to determine which pads meet the federal guidelines. We believe that far greater detail needs to be provided to enable prescribers and pharmacists to identify compliant pads. CMS chose not to endorse a list of TRPP manufacturers out of a concern that the publication of such a list would be considered an endorsement of the manufacturers included, and because each state is best able to ascertain which manufacturers have an existing relationship and level of trade with prescribers in that state. However, we believe it is essential to ensuring compliance that your agency post on its website or forward to Medicaid prescribers and pharmacies a list of TRPP manufacturers serving the state that produce prescription forms known to comply with the statutory mandate. Such a list should include the manufacturer s catalogue (or other identifying) numbers for compliant forms. Maryland and California have already compiled lists of TRPP manufacturers serving their respective states and these can serve as best practice examples. Also, attached to this correspondence is a non-state-specific list of manufacturers we have compiled that can be used to develop state lists; we are prepared to help you further modify and maintain this or any other list you may compile. In addition, the National Council for Prescription Drug Programs (NCPDP) will be working over the next few months to develop a white paper with input from manufacturers, medical association representatives, pharmacy associations, and Medicaid program representatives that outlines which prescription pad characteristics are deemed compliant with the CMS guidelines. It is expected that the manufacturers will want to indicate on their prescription forms that their products comply with the NCPDP guidelines, and this should facilitate state Medicaid program identification. We ask that you join with us in urging the pad manufacturers to conform their forms to these standards labeling their forms as NCPDP-compliant once the standards have been published. We also want to remind you that CMS previously stated it is willing to provide an administrative funding match to states that choose to adopt and distribute an official prescription form that is compliant with the TRPP mandate. We ask you to consider the cost advantages of doing so; the savings in reduced fraud and abuse are likely to offset the state s portion of the costs of adopting and distributing an official form. In considering whether to adopt an official form or compile an informational list of compliant pads, we suggest that you consider the likely alternative scenario: Pharmacists, unable to determine whether the prescription form they hold is compliant, will likely call the Medicaid-participating prescriber for confirmation of the prescription, as permitted under SMDL # This will provide an additional administrative burden for each prescriber and pharmacist, and will likely delay the dispensing of crucial medications to Medicaid beneficiaries. In extreme cases where pharmacies are unable to reach the prescribing provider within the emergency fill period, beneficiaries could be denied their medications for an extended time. We believe that providing greater clarity to prescribers and pharmacies through a detailed guidance on which TRPPs meet compliance standards would help avoid these potential difficulties. Identification of State-Specific Implementation Issues We also ask that you inform prescribers and pharmacies in your state if you will be taking approaches to implementation that vary from those mandated and authorized under the broader CMS guidance either in requiring pads for additional Medicaid populations, such as for the managed care population, or in requiring pads under additional circumstances, such as for refills of prescriptions written prior to April 1. Other

7 specific issues addressed in the state guidance should include: (1) What the state limitation will be on the duration of the emergency supply filled while verbal authorization is sought by the pharmacy from the prescriber, and what subsequent documentation will be required of that verbal authorization. (2) Whether prescribers will be limited in the number of tamper-resistant pads they can possess on hand at any one time in order to guard against theft. (3) The mechanisms and procedures established for acceptance of pads authorized and utilized by prescribers in adjoining and snowbird states, and how updates will be communicated. (4) If you are one of the handful of states that implemented mandatory prescription pad requirements for some but not all Medicaid drugs prior to the federal implementation date, how that existing requirement will be expanded or modified to comply with the federal mandate. Elimination of Implementation Phase-In Period If a method can be devised for clearly and unambiguously indicating to prescribers and pharmacists that a prescription form is compliant, we suggest that you meet with the state and local medical and pharmacy associations operating in your state to discuss whether to require that all three conditions be met on April 1, 2008, rather than six months following implementation. Both prescribers and pharmacies should be willing to support elimination of the transition period because it will likely be easier for them to comply with one set of standards within a six-month period rather than two sets. However, a meeting of your Department with prescribers and pharmacies in the state will ensure that there is a consensus that an April 1, 2008 full implementation is practical, feasible, and desirable. If full compliance is to be required on April 1, we strongly suggest that your state consider a 60-day moratorium on audits for compliance with the mandate to give prescribers and pharmacists the time to grow comfortable with the requirement, the handling of the prescription pads, and procedures for obtaining and documenting verbal authorizations. Education of Prescribers, Pharmacists, and Beneficiaries Finally, the short time frame for implementation initially made formal outreach to and training and education of prescribers, pharmacists, and affected beneficiaries difficult. That time frame has now been extended, and we urge you to schedule outreach on this new mandate to and training of all affected persons. Prescribers and pharmacies will need to be made aware of the details of how the mandate will be implemented in your state and how qualifying pads will be identified. In addition, Medicaid beneficiaries will need to be informed perhaps through a Frequently Asked Questions (FAQ) information card that changes in federal law governing how their prescriptions may be written could, at least initially, lead to a delay in how quickly they may receive their medications. The signatories below all volunteer to work with state programs in developing the necessary outreach, training, and educational programs and materials to help assure prescriber and pharmacy compliance. The undersigned advocacy organizations are prepared to help with outreach to affected beneficiaries. If you have any questions regarding this correspondence, please contact Stuart Yael Gordon, Director of Public Policy, National Association of Chain Drug Stores, at sgordon@nacds.org or Thank you for your attention to this very crucial issue.

8 Sincerely, National Association of Chain Drug Stores National Community Pharmacists Association American Pharmacists Association National Alliance of State Pharmacy Associations Food Marketing Institute National Association of Community Health Centers Alaska Pharmacists Association Arkansas Pharmacists Association Arizona Pharmacy Alliance California Pharmacists Association Colorado Pharmacists Society Connecticut Pharmacists Association Delaware Pharmacists Society Florida Pharmacy Association Georgia Pharmacy Association Illinois Pharmacists Association Indiana Pharmacists Alliance Iowa Pharmacy Association Kansas Pharmacists Association Kentucky Pharmacists Association Maryland Pharmacists Association Massachusetts Pharmacists Association Michigan Pharmacists Association Minnesota Pharmacists Association Mississippi Pharmacists Association Missouri Pharmacists Association Nebraska Pharmacists Association New Hampshire Pharmacists Association New Mexico Pharmacists Association Pharmacists Society of the State of New York North Carolina Association of Pharmacists North Dakota Pharmacists Association Ohio Pharmacists Association Oklahoma Pharmacists Association Pennsylvania Pharmacists Association Rhode Island Pharmacists Association South Carolina Pharmacy Association South Dakota Pharmacists Association Texas Pharmacy Association Utah Pharmacists Association Vermont Pharmacists Association Virginia Pharmacists Association Washington State Pharmacy Association West Virginia Pharmacists Association Pharmacy Society of Wisconsin Wyoming Pharmacy Association American Medical Association American College of Physicians American Academy of Family Physicians American College of Obstetricians and Gynecologists American Academy of Pediatrics American Psychological Association Medical Group Management Association Alaska State Medical Association California Medical Association Connecticut State Medical Society Medical Society of Delaware Medical Society of the District of Columbia Florida Medical Association,

9 January 2, 2008 Mr. Roy Jeffus Director Division of Medical Services AR Department of Health and Human Services P.O. Box 1437, Slot S Main Street Little Rock, AR Re: Implementation of the Federal Tamper-Resistant Prescription Pad Mandate Dear Mr. Jeffus: The undersigned 90 pharmacy and medical organizations are writing to request that additional guidance be provided by your agency to prescribers, pharmacies, and Medicaid beneficiaries in your state regarding compliance with the federal statute requiring the use of tamper-resistant prescription pads (TRPPs) under Medicaid. 3 We are concerned that in the absence of additional guidance, members of the state s vulnerable Medicaid population could find themselves at risk of having medications delayed for hours or days, or even denied. Specifically, we are asking that you issue a detailed guidance that would clearly identify compliant prescription forms distributed in the state and state-specific implementation issues governing prescriptions covered by the mandate. We also request that you consult the state and local medical and pharmacy associations in your state to determine the feasibility and desirability of eliminating the federally suggested six-month phase-in period. Finally, we urge that you work with the undersigned organizations and the pharmacy and medical associations in your state in developing prescriber, pharmacy and pharmacist, and beneficiary outreach and education about the TRPP mandate and its implementation. Background The statutory provision mandating TRPP use was enacted on May 25, 2007, and because it was originally to take effect on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) was hard-pressed to draft a timely State Medicaid Directors guidance on its implementation before the scheduled effective date. State Medicaid Director Letter #07-012, providing CMS s expectations on how states would enforce the TRPP mandate, was published on August 17, This left your program and others little time to develop detailed implementation plans for inclusion in notices to providers, and little time to conduct extensive outreach to prescribers, pharmacies, and beneficiaries regarding the mandate. Many states only had time to forward to providers the broad outlines of the CMS guidance. CMS original guidance allowed states to phase in the requirement over a year s time. For the first year, a prescription pad would have had to contain at least one of the following characteristics: (1) at least one industry-recognized feature designed to prevent unauthorized copying, (2) at least one industry recognized feature designed to prevent erasure or modification, and (3) at least one industry recognized feature designed to prevent counterfeiting. In the second and final phase, not later than October 1, 2008, a prescription pad would have been required to meet all three characteristics. On September 29, 2007, two days before the mandate was to take effect, President Bush signed P.L , delaying the effective date for tamper-resistant prescription pads by six months, to April 1, Following (b) of the U.S. Troop Readiness, Veterans Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007.

10 the signing of the legislation, CMS stated in a list-serve message to affected stakeholders that, despite the 6- month initial implementation delay, all pads would still be required to have all three of the required characteristics by October 1, Greater Detail Needed in Describing Compliant Pads The notices forwarded by many states to prescribers and pharmacies provided little additional detail beyond the broad requirements of SMDL #07-012, leaving it to those providers to determine which pads meet the federal guidelines. We believe that far greater detail needs to be provided to enable prescribers and pharmacists to identify compliant pads. CMS chose not to endorse a list of TRPP manufacturers out of a concern that the publication of such a list would be considered an endorsement of the manufacturers included, and because each state is best able to ascertain which manufacturers have an existing relationship and level of trade with prescribers in that state. However, we believe it is essential to ensuring compliance that your agency post on its website or forward to Medicaid prescribers and pharmacies a list of TRPP manufacturers serving the state that produce prescription forms known to comply with the statutory mandate. Such a list should include the manufacturer s catalogue (or other identifying) numbers for compliant forms. Maryland and California have already compiled lists of TRPP manufacturers serving their respective states and these can serve as best practice examples. Also, attached to this correspondence is a non-state-specific list of manufacturers we have compiled that can be used to develop state lists; we are prepared to help you further modify and maintain this or any other list you may compile. In addition, the National Council for Prescription Drug Programs (NCPDP) will be working over the next few months to develop a white paper with input from manufacturers, medical association representatives, pharmacy associations, and Medicaid program representatives that outlines which prescription pad characteristics are deemed compliant with the CMS guidelines. It is expected that the manufacturers will want to indicate on their prescription forms that their products comply with the NCPDP guidelines, and this should facilitate state Medicaid program identification. We ask that you join with us in urging the pad manufacturers to conform their forms to these standards labeling their forms as NCPDP-compliant once the standards have been published. We also want to remind you that CMS previously stated it is willing to provide an administrative funding match to states that choose to adopt and distribute an official prescription form that is compliant with the TRPP mandate. We ask you to consider the cost advantages of doing so; the savings in reduced fraud and abuse are likely to offset the state s portion of the costs of adopting and distributing an official form. In considering whether to adopt an official form or compile an informational list of compliant pads, we suggest that you consider the likely alternative scenario: Pharmacists, unable to determine whether the prescription form they hold is compliant, will likely call the Medicaid-participating prescriber for confirmation of the prescription, as permitted under SMDL # This will provide an additional administrative burden for each prescriber and pharmacist, and will likely delay the dispensing of crucial medications to Medicaid beneficiaries. In extreme cases where pharmacies are unable to reach the prescribing provider within the emergency fill period, beneficiaries could be denied their medications for an extended time. We believe that providing greater clarity to prescribers and pharmacies through a detailed guidance on which TRPPs meet compliance standards would help avoid these potential difficulties. Identification of State-Specific Implementation Issues We also ask that you inform prescribers and pharmacies in your state if you will be taking approaches to implementation that vary from those mandated and authorized under the broader CMS guidance either in requiring pads for additional Medicaid populations, such as for the managed care population, or in requiring

11 pads under additional circumstances, such as for refills of prescriptions written prior to April 1. Other specific issues addressed in the state guidance should include: (1) What the state limitation will be on the duration of the emergency supply filled while verbal authorization is sought by the pharmacy from the prescriber, and what subsequent documentation will be required of that verbal authorization. (2) Whether prescribers will be limited in the number of tamper-resistant pads they can possess on hand at any one time in order to guard against theft. (3) The mechanisms and procedures established for acceptance of pads authorized and utilized by prescribers in adjoining and snowbird states, and how updates will be communicated. (4) If you are one of the handful of states that implemented mandatory prescription pad requirements for some but not all Medicaid drugs prior to the federal implementation date, how that existing requirement will be expanded or modified to comply with the federal mandate. Elimination of Implementation Phase-In Period If a method can be devised for clearly and unambiguously indicating to prescribers and pharmacists that a prescription form is compliant, we suggest that you meet with the state and local medical and pharmacy associations operating in your state to discuss whether to require that all three conditions be met on April 1, 2008, rather than six months following implementation. Both prescribers and pharmacies should be willing to support elimination of the transition period because it will likely be easier for them to comply with one set of standards within a six-month period rather than two sets. However, a meeting of your Department with prescribers and pharmacies in the state will ensure that there is a consensus that an April 1, 2008 full implementation is practical, feasible, and desirable. If full compliance is to be required on April 1, we strongly suggest that your state consider a 60-day moratorium on audits for compliance with the mandate to give prescribers and pharmacists the time to grow comfortable with the requirement, the handling of the prescription pads, and procedures for obtaining and documenting verbal authorizations. Education of Prescribers, Pharmacists, and Beneficiaries Finally, the short time frame for implementation initially made formal outreach to and training and education of prescribers, pharmacists, and affected beneficiaries difficult. That time frame has now been extended, and we urge you to schedule outreach on this new mandate to and training of all affected persons. Prescribers and pharmacies will need to be made aware of the details of how the mandate will be implemented in your state and how qualifying pads will be identified. In addition, Medicaid beneficiaries will need to be informed perhaps through a Frequently Asked Questions (FAQ) information card that changes in federal law governing how their prescriptions may be written could, at least initially, lead to a delay in how quickly they may receive their medications. The signatories below all volunteer to work with state programs in developing the necessary outreach, training, and educational programs and materials to help assure prescriber and pharmacy compliance. The undersigned advocacy organizations are prepared to help with outreach to affected beneficiaries. If you have any questions regarding this correspondence, please contact Stuart Yael Gordon, Director of Public Policy, National Association of Chain Drug Stores, at sgordon@nacds.org or Thank you for your attention to this very crucial issue.

12 Sincerely, National Association of Chain Drug Stores National Community Pharmacists Association American Pharmacists Association National Alliance of State Pharmacy Associations Food Marketing Institute National Association of Community Health Centers Alaska Pharmacists Association Arkansas Pharmacists Association Arizona Pharmacy Alliance California Pharmacists Association Colorado Pharmacists Society Connecticut Pharmacists Association Delaware Pharmacists Society Florida Pharmacy Association Georgia Pharmacy Association Illinois Pharmacists Association Indiana Pharmacists Alliance Iowa Pharmacy Association Kansas Pharmacists Association Kentucky Pharmacists Association Maryland Pharmacists Association Massachusetts Pharmacists Association Michigan Pharmacists Association Minnesota Pharmacists Association Mississippi Pharmacists Association Missouri Pharmacists Association Nebraska Pharmacists Association New Hampshire Pharmacists Association New Mexico Pharmacists Association Pharmacists Society of the State of New York North Carolina Association of Pharmacists North Dakota Pharmacists Association Ohio Pharmacists Association Oklahoma Pharmacists Association Pennsylvania Pharmacists Association Rhode Island Pharmacists Association South Carolina Pharmacy Association South Dakota Pharmacists Association Texas Pharmacy Association Utah Pharmacists Association Vermont Pharmacists Association Virginia Pharmacists Association Washington State Pharmacy Association West Virginia Pharmacists Association Pharmacy Society of Wisconsin Wyoming Pharmacy Association American Medical Association American College of Physicians American Academy of Family Physicians American College of Obstetricians and Gynecologists American Academy of Pediatrics American Psychological Association Medical Group Management Association Alaska State Medical Association California Medical Association Connecticut State Medical Society Medical Society of Delaware Medical Society of the District of Columbia Florida Medical Association,

13 January 2, 2008 Mr. Stan Rosenstein Chief Deputy Director, Medi-Cal Health Care Programs CA Department of Health Care Services 1501 Capitol Avenue 6th Floor, MS0002 Sacramento, CA Re: Implementation of the Federal Tamper-Resistant Prescription Pad Mandate Dear Mr. Rosenstein: The undersigned 90 pharmacy and medical organizations are writing to request that additional guidance be provided by your agency to prescribers, pharmacies, and Medicaid beneficiaries in your state regarding compliance with the federal statute requiring the use of tamper-resistant prescription pads (TRPPs) under Medicaid. 4 We are concerned that in the absence of additional guidance, members of the state s vulnerable Medicaid population could find themselves at risk of having medications delayed for hours or days, or even denied. Specifically, we are asking that you issue a detailed guidance that would clearly identify compliant prescription forms distributed in the state and state-specific implementation issues governing prescriptions covered by the mandate. We also request that you consult the state and local medical and pharmacy associations in your state to determine the feasibility and desirability of eliminating the federally suggested six-month phase-in period. Finally, we urge that you work with the undersigned organizations and the pharmacy and medical associations in your state in developing prescriber, pharmacy and pharmacist, and beneficiary outreach and education about the TRPP mandate and its implementation. Background The statutory provision mandating TRPP use was enacted on May 25, 2007, and because it was originally to take effect on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) was hard-pressed to draft a timely State Medicaid Directors guidance on its implementation before the scheduled effective date. State Medicaid Director Letter #07-012, providing CMS s expectations on how states would enforce the TRPP mandate, was published on August 17, This left your program and others little time to develop detailed implementation plans for inclusion in notices to providers, and little time to conduct extensive outreach to prescribers, pharmacies, and beneficiaries regarding the mandate. Many states only had time to forward to providers the broad outlines of the CMS guidance. CMS original guidance allowed states to phase in the requirement over a year s time. For the first year, a prescription pad would have had to contain at least one of the following characteristics: (1) at least one industry-recognized feature designed to prevent unauthorized copying, (2) at least one industry recognized feature designed to prevent erasure or modification, and (3) at least one industry recognized feature designed to prevent counterfeiting. In the second and final phase, not later than October 1, 2008, a prescription pad would have been required to meet all three characteristics. On September 29, 2007, two days before the mandate was to take effect, President Bush signed P.L , delaying the effective date for tamper-resistant prescription pads by six months, to April 1, Following (b) of the U.S. Troop Readiness, Veterans Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007.

14 the signing of the legislation, CMS stated in a list-serve message to affected stakeholders that, despite the 6- month initial implementation delay, all pads would still be required to have all three of the required characteristics by October 1, Greater Detail Needed in Describing Compliant Pads The notices forwarded by many states to prescribers and pharmacies provided little additional detail beyond the broad requirements of SMDL #07-012, leaving it to those providers to determine which pads meet the federal guidelines. We believe that far greater detail needs to be provided to enable prescribers and pharmacists to identify compliant pads. CMS chose not to endorse a list of TRPP manufacturers out of a concern that the publication of such a list would be considered an endorsement of the manufacturers included, and because each state is best able to ascertain which manufacturers have an existing relationship and level of trade with prescribers in that state. However, we believe it is essential to ensuring compliance that your agency post on its website or forward to Medicaid prescribers and pharmacies a list of TRPP manufacturers serving the state that produce prescription forms known to comply with the statutory mandate. Such a list should include the manufacturer s catalogue (or other identifying) numbers for compliant forms. Maryland and California have already compiled lists of TRPP manufacturers serving their respective states and these can serve as best practice examples. Also, attached to this correspondence is a non-state-specific list of manufacturers we have compiled that can be used to develop state lists; we are prepared to help you further modify and maintain this or any other list you may compile. In addition, the National Council for Prescription Drug Programs (NCPDP) will be working over the next few months to develop a white paper with input from manufacturers, medical association representatives, pharmacy associations, and Medicaid program representatives that outlines which prescription pad characteristics are deemed compliant with the CMS guidelines. It is expected that the manufacturers will want to indicate on their prescription forms that their products comply with the NCPDP guidelines, and this should facilitate state Medicaid program identification. We ask that you join with us in urging the pad manufacturers to conform their forms to these standards labeling their forms as NCPDP-compliant once the standards have been published. We also want to remind you that CMS previously stated it is willing to provide an administrative funding match to states that choose to adopt and distribute an official prescription form that is compliant with the TRPP mandate. We ask you to consider the cost advantages of doing so; the savings in reduced fraud and abuse are likely to offset the state s portion of the costs of adopting and distributing an official form. In considering whether to adopt an official form or compile an informational list of compliant pads, we suggest that you consider the likely alternative scenario: Pharmacists, unable to determine whether the prescription form they hold is compliant, will likely call the Medicaid-participating prescriber for confirmation of the prescription, as permitted under SMDL # This will provide an additional administrative burden for each prescriber and pharmacist, and will likely delay the dispensing of crucial medications to Medicaid beneficiaries. In extreme cases where pharmacies are unable to reach the prescribing provider within the emergency fill period, beneficiaries could be denied their medications for an extended time. We believe that providing greater clarity to prescribers and pharmacies through a detailed guidance on which TRPPs meet compliance standards would help avoid these potential difficulties. Identification of State-Specific Implementation Issues We also ask that you inform prescribers and pharmacies in your state if you will be taking approaches to implementation that vary from those mandated and authorized under the broader CMS guidance either in requiring pads for additional Medicaid populations, such as for the managed care population, or in requiring

15 pads under additional circumstances, such as for refills of prescriptions written prior to April 1. Other specific issues addressed in the state guidance should include: (1) What the state limitation will be on the duration of the emergency supply filled while verbal authorization is sought by the pharmacy from the prescriber, and what subsequent documentation will be required of that verbal authorization. (2) Whether prescribers will be limited in the number of tamper-resistant pads they can possess on hand at any one time in order to guard against theft. (3) The mechanisms and procedures established for acceptance of pads authorized and utilized by prescribers in adjoining and snowbird states, and how updates will be communicated. (4) If you are one of the handful of states that implemented mandatory prescription pad requirements for some but not all Medicaid drugs prior to the federal implementation date, how that existing requirement will be expanded or modified to comply with the federal mandate. Elimination of Implementation Phase-In Period If a method can be devised for clearly and unambiguously indicating to prescribers and pharmacists that a prescription form is compliant, we suggest that you meet with the state and local medical and pharmacy associations operating in your state to discuss whether to require that all three conditions be met on April 1, 2008, rather than six months following implementation. Both prescribers and pharmacies should be willing to support elimination of the transition period because it will likely be easier for them to comply with one set of standards within a six-month period rather than two sets. However, a meeting of your Department with prescribers and pharmacies in the state will ensure that there is a consensus that an April 1, 2008 full implementation is practical, feasible, and desirable. If full compliance is to be required on April 1, we strongly suggest that your state consider a 60-day moratorium on audits for compliance with the mandate to give prescribers and pharmacists the time to grow comfortable with the requirement, the handling of the prescription pads, and procedures for obtaining and documenting verbal authorizations. Education of Prescribers, Pharmacists, and Beneficiaries Finally, the short time frame for implementation initially made formal outreach to and training and education of prescribers, pharmacists, and affected beneficiaries difficult. That time frame has now been extended, and we urge you to schedule outreach on this new mandate to and training of all affected persons. Prescribers and pharmacies will need to be made aware of the details of how the mandate will be implemented in your state and how qualifying pads will be identified. In addition, Medicaid beneficiaries will need to be informed perhaps through a Frequently Asked Questions (FAQ) information card that changes in federal law governing how their prescriptions may be written could, at least initially, lead to a delay in how quickly they may receive their medications. The signatories below all volunteer to work with state programs in developing the necessary outreach, training, and educational programs and materials to help assure prescriber and pharmacy compliance. The undersigned advocacy organizations are prepared to help with outreach to affected beneficiaries. If you have any questions regarding this correspondence, please contact Stuart Yael Gordon, Director of Public Policy, National Association of Chain Drug Stores, at sgordon@nacds.org or Thank you for your attention to this very crucial issue.