Medicare Part D Impacts on State Boards of Pharmacy American Society for Automation in Pharmacy 2006 Midyear Industr

1. Medicare Part D Impacts on State Boards of Pharmacy American Society for Automation in Pharmacy 2006 Midyear Industry & Technology Issues ConferencePalm Beach, FloridaJune 23, 2006 Eleni Z. Anagnostiadis, R.Ph. Board Services Director, NABP

2. Learning Objectives At the conclusion of this session participants will be able to: Describe the Medicare Part D regulatory requirements that will impact the pharmacy profession in three areas: electronic prescribing medication therapy management recordkeeping requirements

3. Electronic Prescribing Center for Medicare and Medicaid Services (CMS) - Electronic Prescribing (E-Rx) Final Rule What is it? First set of final standards for an electronic prescription drug program for Medicare patients under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) Preempts state laws/rules that prevent prescribers from electronically transmitting prescriptions for covered medications for Medicare-eligible patients Effective 1-1-06

4. Electronic Prescribing CMS E-Rx Final Rule - Preemption How is CMS interpreting the preemption portion of this rule? Broad interpretation Preemption pertains to: All prescriptions transmitted electronically for “Part D-eligible individuals” (all Medicare participants) For “drugs that may be covered by Part D in at least some circumstances, whether or not that particular prescription is covered under Part D in those specific circumstances.”

5. Electronic Prescribing CMS E-Rx Final Rule Which state laws/rules may be preempted? Those that expressly prohibit electronic prescribing Those that prohibit the transmission of electronic prescriptions through intermediaries, such as networks, switches, PBMs

6. Electronic Prescribing CMS E-Rx Final Rule Which state laws/rules may be preempted? Those that prohibit access to electronic prescriptions by plans or their agents or other authorized third parties Those that require certain language to be used, such as “dispense as written,” to indicate whether generic drugs may or may not be substituted, insofar as such language is not consistent with the adopted standard

7. Electronic Prescribing CMS E-Rx Final Rule Which state laws/rules may be preempted? (cont) Those that require handwritten signatures or other handwriting on prescriptions Other state laws or rules, such as state privacy laws with certain digital signature or prescriber authentication requirements, may impact this rule. CMS plans future preemption assessments upon identification of specific problematic laws or rules.

8. Electronic Prescribing CMS E-Rx Final Rule - Preemption impact? Two different sets of electronic prescribing rules may emerge: one set for Medicare-eligible patients and the other for non-Medicare eligible patients. For example, electronic Rxs for Medicare-eligible patients would be valid: Even if the state law expressly prohibits electronic prescribing. Even if they are transmitted through and accessed by a third-party plans; Even if required handwriting is not present. Another example, generic substitution when “Brand Medically Necessary” is specified. generic substitution would be prohibited if indicated by the prescriber according to the prescribing standard, even if the specifically required language (e.g. “dispense as written”) is present. generic substitution would be prohibited if indicated by the prescriber according to the prescribing standard, even if the specifically required language (e.g. “dispense as written”) is present.

9. Electronic Prescribing What is NABP doing in this area? NABP Model Act Requires that prescription drug orders “be transmitted directly to a pharmacist or certified pharmacy technician in a licensed pharmacy of the patient’s choice with no intervening person having access to the prescription drug order.” CMS anticipates: Computer -> Computer; as well as, Computer -> fax machine in office -> fax in pharmacy NABP’s Committee on Law/Enforcement Legislation and Executive Committee considering amendments.

10. Electronic Prescribing How prevalent is this preemption issue in the states? NABP Findings* Number of jurisdictions that expressly prohibit electronic prescribing = 1 jurisdiction Number of jurisdictions that prohibit the transmission of electronic prescriptions through intermediaries or that prohibit access to such prescriptions by plans or their agents or other duly authorized third parties = 16 *Sources: NABP’s NABPLAW Online Database and the 2006 NABP Survey of Pharmacy Law DC, MaineDC, Maine

11. Electronic Prescribing How prevalent is this preemption issue? NABP Findings (continued) Number of jurisdictions that require certain language to be used, such as “dispense as written,” to indicate whether generic drugs may or may not be substituted, insofar as such language is not consistent with the adopted standard = 25 Number of jurisdictions that require handwritten signatures or other handwriting on prescriptions (including “dispense as written,” etc.) = 25

12. Medication Therapy Management (MTM) What are the guidelines for MTM in the Final Medicare Part D Regulations? Enhanced enrollee understanding through beneficiary education counseling and other means that promote appropriate use of medications and reduce the risks of potential adverse events associated with medications.

13. Medication Therapy Management (MTM) What are the guidelines for MTM in the Final Medicare Part D Regulations? (continued) Increased enrollee adherence to prescription medication regimens Examples include: refill reminders, special packaging, compliance programs, and other appropriate means.

14. Medication Therapy Management (MTM) What are the guidelines for MTM in the Final Medicare Part D Regulations? (continued) Detection of adverse events and patterns of overuse and under-use of prescription drugs.

15. Medication Therapy Management (MTM) What activities do not qualify as MTM interventions? OBRA 90 counseling Long-term care (LTC) consultant pharmacist services (which are already required in LTC facilities)

16. Medication Therapy Management (MTM) Who qualifies for Part D MTM services? Three criteria* must be met for beneficiary to qualify: Multiple chronic diseases Prescriptions filled for multiple covered Part D drugs Likely to incur annual costs of at least $,4000 (2006 amount) for all covered Part D drugs. * Criteria may be unique to each of the Part D plan sponsors as approved by CMS.

17. Recordkeeping Requirements Under MMA, how many years are pharmacists required to retain prescription records? Ten (10) years

18. Recordkeeping Requirements Paper prescriptions kept on file for 3 years* After 3 years, prescriptions can be transferred to electronic format and maintained for the remaining 7 years, as long as reasonably accessible.* * CMS stresses that this administrative requirement only applies to prescriptions.

19. Recordkeeping Requirements Other records that must be retained for Medicare under Parts C and D should be retained in the formats required by either: State law; HIPAA; or If applicable, the prescription drug plan’s discretion.

20. Conclusion E-prescribing standards for 2006 were just the beginning. Other standards are being tested in various, currently ongoing demonstration projects. The results of the demos should be know Spring 2007 with implementation of additional standards for 2008.

21. Questions?

22. Eleni Anagnostiadis, RPh Board Services Director, NABP eanagnostiadis@nabp.net, 301/214-9078 Visit the NABP website at www.nabp.net