E-Prescribing and the Medicare Prescription Drug Program. Maria A. Friedman, DBA Office of E-Health Standards and Services November 17, 2005

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1 E-Prescribing and the Medicare Prescription Drug Program Maria A. Friedman, DBA Office of E-Health Standards and Services November 17,

2 Benefits of E-Prescribing Patients Improves patient safety/reduces medication errors Improves quality of care Physicians Improves quality and efficiency Reduces costs Pharmacies Instant connectivity between providers, pharmacies, and health plans/pbms improves speed and accuracy of dispensing, pharmacy callbacks, eligibility checks, and medication history Health Plans Promotes use of cheaper, therapeutically equivalent drugs 2

3 E-Prescribing under the MMA Voluntary for physicians and pharmacies Part D plans must support e-prescribing, should their physicians and pharmacies desire to do it If e-prescribing is done, must use standards promulgated now and in the future 3

4 MMA E-Prescribing Timeline Announcement of Initial Standards - September 2005 Pilot begins - January 2006 Part D goes live - January 2006 Report to Congress on Pilot - April 2007 Additional Standards Final Rule - April

5 How E-Prescribing Standards Developed under MMA Initial standards must be tested through pilot project during CY 06 EXCEPTION Pilot testing not required where there is adequate industry experience NPRM proposed foundation standards where adequate industry experience exists Three foundation standards with adequate industry experience adopted in final rule, published on November 7,

6 Adopted Foundation Standards NCPDP SCRIPT standard, Version 5, Release 0 (except for the Prescription Fill Status Notification Transaction) - for transactions between prescribers and dispensers for: New prescriptions Prescription refill requests and response Prescription change request and response Prescription cancellation request and response Ancillary messaging and administrative transactions 6

7 Adopted Foundation Standards (cont) ASC X12N 270/271, Version 4010 and Addenda for eligibility and benefits inquiries and responses between prescribers and Part D sponsors 7

8 Adopted Foundation Standards (cont) NCPDP Telecommunications Standard, Version 5.1 (and the equivalent Batch Standard, Version 1.1) for eligibility and benefits inquiries and responses between dispensers and Part D sponsors 8

9 State preemption Several categories of State laws are preempted, in whole or in part, effective January 1, They are preempted to the extent that they apply to covered Part D drugs that are electronically prescribed for Part D eligible individuals and restrict the Department s ability to carry out the e-prescribing program. The categories are: State laws that expressly prohibit electronic prescribing. State laws that prohibit the transmission of electronic prescriptions through intermediaries, such as networks and switches or PBMs, or that prohibit access to such prescriptions by plans or their agents or other duly authorized third parties. State laws that require certain language to be used, such as dispense as written, to indicate whether generic drugs may or may not be substituted in so far as such language is not consistent with the adopted standards. State laws that require handwritten signatures or other handwriting on prescriptions. 9

10 Exemptions Computer-generated faxes LTC facilities Internal messaging for staff model HMOs and other closed systems BUT they must be able to convert their messages to NCPDP SCRIPT if they are sending them outside to a non-network pharmacy Also must accept prescriptions sent using NCPDP from outside 10

11 Pilot testing E-rx Standards Required to pilot test standards for which there is not adequate industry experience Voluntary participation via agreements with the Secretary Conducted during Calendar Year 2006 Pilot testing results will be used to develop final e-prescribing standards to be adopted in

12 Pilot Testing Timeline Projects to be competitively awarded Cooperative agreements CMS collaborating with AHRQ, which announced the RFA on Roughly a dozen proposals will be evaluated by a peer review group, which will meet Awards to be made by Evaluation contract has not yet been awarded 12

13 Additional Standards to be Pilot Tested Formulary and benefit information - NCPDP standard using RxHub protocol Exchange of medication history NCPDP standard medication history message using RxHub protocol Structured and Codified Sig Test structured and codified SIGs (patient instructions) developed through standards development organization efforts Clinical drug terminology Determine whether RxNorm terminology translates to NDC for new prescriptions, renewals and changes Prior authorization messages - New version of ANSI ASC X

14 Issues in E-Rx Adoption and Diffusion Privacy In general Safeguarding info on sensitive health conditions (HIV-AIDS, mental health, substance abuse) Data access Who owns data Who has access Under what circumstances and who decides Treatment concerns/imperatives vs individual patient wishes/rights Quality improvement (eg, pay for performance), reimbursement, patient safety Consumer Confusion Physicians like most consumers generally confused by systems specs, applications, vendors How do you know what to buy? Physician offices typically IT challenged 14

15 Issues in e-rx adoption and diffusion Volatility of HIT New systems being developed Interoperability How pieces work together ultimately to create electronic medical records and national health information network Costs No good cost data Expensive for physicians Incentives? 15

16 Issues in e-rx adoption and diffusion Regulatory environment Regulatory environment fragmented E-rx under MMA E-rx for States E-rx for controlled substances (TBD by DEA) Vendors reluctant to create different systems to address circumstances in specific states, patient populations 16

17 QUESTIONS? 17

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