Electronic Prescribing Update

1
Electronic Prescribing Update

• Tony Trenkle
• Director
• Office of E-Health Standards and Services
• Centers for Medicare Medicaid Services
• December 5, 2008

2
What is E-Prescribing under Part D?

• E-prescribing is the transmission of prescription
  or prescription related information between
  prescriber, dispenser, pharmacy benefit manager,
  or health plan, either directly or through an
  intermediary using electronic media
• Employs adopted Part D e-prescribing standards
  initiated through MMA
• E-prescribing is voluntary under Part D

3
Key CMS Standards Activities

• Foundation Standards implemented January 1 2006
• E-prescribing pilots conducted CY 2006
• Report to Congress delivered April 2007
• Final Uniform Standards published April 2008,
  effective April 2009

4
Approach Building Suite of Standards

• Not a one shot deal
• Look for mature standards with a track record
• Work with industry to grow other standards as
  needed
• NCVHS as advisor / convener

5
Standards Round One

• Foundation standards effective January 2006
• Enabled basic functions
• Prescriber and pharmacy checking patients
  eligibility with plans
• Exchange of new prescriptions, refill requests,
  cancellations, and changes between prescribers
  and pharmacies
• Advantages
• Eliminates errors associated with handwriting and
  mis-keying
• Reduces administrative costs associated with
  phone calls

6
Standards Round Two

• 2006 Pilot Test looked at additional standards
• Formulary and benefits
• Medication history
• Rx-fill
• RxNorm
• Structured / codified Sig
• Prior Authorization

7
Standards Round Two (contd)

• Results
• Formulary and benefits, medication history,
  Rx-fill ready for adoption
• More work needed on RxNorm, Sig and Prior
  Authorization
• Final Rule published on 4/7/2008-Effective
  4/1/2009
• Adopted Formulary and benefits, medication
  history, Rx-fill
• Retired NCPDP 5.0 and replaced with version 8.1
• Required the use of National Provider Identifier
  (NPI) as an individual identifier

8
Next Steps Standards and Adoption

• Re-test RxNorm and Structured / Codified Sig and
  test new Standards
• Modifications made as a result of 2006 pilot and
  February 2008 industry experts meeting on next
  steps for standards that were not ready for
  adoption
• RAND awarded contract to pilot test RxNorm and
  Structured / Codified Sig NCPDPT SCRIPT 10.5
• Pilot scheduled to run 12/08-9/09
• Partnership with AHRQ to continue to develop
  Prior Authorization business process and
  standards
• Future standards work as need is identified

9
Next Steps Computer Generated Fax

• 2005 Standards regulation gave an exemption from
  use of SCRIPT standard for entities using
  computer-generated fax technology
• Exemption tightened in last years Physician Fee
  Schedule (PFS) regulation to apply only to
  temporary transmission problems, effective
  1/1/2009
• New information raised concerns about unintended
  consequences regarding refills
• In this years PFS NPRM, proposed retaining
  exemption for prescription refill requests
• Comments received and MIPPA Legislation led to a
  decision to reinstate the exemption until 2012 to
  link with MIPPA disincentives.

10
Other CMS Initiatives

• Stark Rule-e-prescribing exception-August
  2006-Allows hospitals and other specified groups
  to make non-momentary donations to physicians
  consisting only of items and services in the form
  of hardware, software, or information and
  training services that are necessary and used
  solely to receive and transmit electronic
  prescription information.
• Medicaid
• Transformation Grants 2-year, 150M program
  that grants funds to states for adoption of
  innovative methods to improve effectiveness and
  efficiency through e-prescribing and other HIT
  initiatives
• States doing e-Rx with an MTG AZ, NM, DE, TN,
  CT, AL, FL
• No State matching required
• 24-36 months
• Evaluation requirements include clinical
  improvements and cost savings to Medicaid
• Leverage Medicaid to provide incentives to
  promote e-prescribing
• QIO 9th Scope of Work E-prescribing special
  study-patient safety

11
Drug Enforcement Administration (DEA) NPRM

• Controlled Substances Schedule II V drugs
  cannot be prescribed electronically
• DEA Issued a notice of proposed rulemaking (NPRM)
  in July, 2008 comment period closed September
  25, 2008 over 200 comments received
• DEA is most concerned about
• Authentication of the prescriber
• Non-repudiation of the prescription
• Integrity of the record keeping process

12
DEA NPRMRequirement Examples

• Provider Requirements
• In-person identity proofing
• 2 factor authentication (including hard token)
• 12 hour notification to DEA and vendor in the
  event hard token is lost or stolen
• Vendor Requirements
• The system must require at least 2 factor
  identification
• System must limit signing authority to those with
  legal rights
• System must have an automatic lockout if unused
  for more than 2 minutes
• Pharmacy Requirements
• Pharmacy or last intermediary must digitally sign
• Pharmacy must archive just as received
• Digital signatures must meet requirements of FIPS
  180-2 and 186-2
• Pharmacy or intermediary- valid DEA registration
• Pharmacy must conduct daily internal audits
• Pharmacy system must have a backup stored at a
  separate location

13
DEA-HHS Coordination

• HHS is working with DEA to develop a final rule
  that allows the e-prescribing of controlled
  substances such that it
• Is Interoperable with existing e-prescribing
  systems
• Is scaleable to work throughout the healthcare
  system without imposing an undue burden
• Promotes overall e-prescribing adoption
• HHS-DEA have formed a working group and a
  leadership team
• The working group is
• Reviewing NPRM comments
• Determine which requirements can be eliminated or
  changed
• Any remaining issues will be worked out through
  the leadership team or at the political level.
• The final rule should be published next year

14
Next Steps

• Incentives
• Continue to fine-tune the program to promote
  overall e-prescribing adoption but also look at
  ways to promote the use of key transactions.
  E.g. medication history
• Promote incentives in the Medicaid program and
  encourage private sector plans to continue and
  expand their incentives programs.
• Re-look at the Stark rule to see if further
  modifications are needed. E.g standards clause
• Standards/Certification
• Focus on completing standards suite
• Integrating controlled substances into the
  workflow
• CCHIT standalone e-prescribing system
  certification
• Education and outreach
• Work with EHI and other industry leaders to
  promote and educate.
• Need additional analysis to measure adoption
  progress and e-prescribing effectiveness