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http://www.ncvhs.hhs.gov/040902lt2.htm  and http://www.ncvhs.hhs.gov/050304lt.pdf .

8 Medicare Program; E-Prescribing and the Prescription Drug Program; Final Rule.  70 FR 67568, November 7, 2005.

In addition to publishing foundation standards in 2005, the Secretary also recognized six “initial standards” for pilot testing, consistent with the MMA’s requirement.  Those six initial standards address: formulary and benefit information; exchange of medication history; fill status notification (RxFill); structured patient instructions (SIG); clinical drug terminology (RxNorm); and prior authorization messaging.9  The HHS e-prescribing pilot utilizes five pilot sites to test the initial standards.  The pilot was set up to validate initial standards and their interoperability with existing foundation standards as well as to look at workflow issues associated with e-prescribing.  CMS published a Report to Congress in April 2007, detailing the results of the pilot testing.10 

On November 16, 2007, CMS published a notice of proposed rulemaking to adopt two of the six pilot tested initial standards (related formulary and benefit information, and exchange of medication history) as “Final Uniform Standards.”11  These proposed standards would supplement the foundation standards that took effect on January 1, 2006.  The proposed formulary and benefit standard is intended to provide prescribers with information about a patient’s drug coverage at the point of care.  This may include information on formulary status and a list of alternative drugs that allow the provider in many cases to substitute a generic drug, thus saving the patient money.  The goal is to enable the prescriber to take this information into account at the time of prescribing, which could reduce the amount of back-and-forth communication needed with the pharmacy or the health plan.  

The medication history standard is the second standard CMS proposes to implement in the near term.  This standard is intended to provide a uniform means for prescribers, dispensers, and payers to communicate about the list of drugs that have been dispensed to the patient.   This standard is widely accepted and employed by those currently using e-prescribing.

9Findings from the Evaluation of E-Prescribing Pilot Sites.  Agency for Healthcare Research and Quality (AHRQ) Publication 07-0047 EF, April 2007, at viii.

10 Id.

11 72 FR 64900.

Pilot testing found that three remaining initial standards – Codified SIG, RxNorm, and prior authorization messaging – require additional work before they could be proposed as final uniform standards.  The sixth standard – RxFill – is ready for Part D use but has not been proposed as a final standard due to an absence of marketplace demand at this time.12  

At the end of the day, regardless of rulemaking, industry collaboration, or pilot testing, e-prescribing remains voluntary in Medicare and essentially throughout the health care marketplace.  CMS is committed to continued testing and work with industry experts to advance the development of secure, scaleable and administratively feasible e-prescribing standards for use throughout the health care system. The challenge in moving forward is that the law does not treat all prescriptions the same.  We look forward to addressing the challenges posed by controlled substances in future pilot programs.  

Collaboration with DEA and Others

Concurrent with work to standardize e-prescribing in the Part D arena, CMS has been collaborating with the Drug Enforcement Administration (DEA) of the U.S. Department of Justice in recent years to identify and adopt commercially scaleable solutions that will allow for the e-prescribing of controlled substances consistent with the e-prescribing of non-controlled substances.  The NCVHS held hearings in 2005 with testimony from various stakeholders including DEA, and published a recommendation letter to the Secretary in March 2005 in which they recommended that HHS, DEA, and state boards of pharmacy recognize “current e-prescribing network practices…as a basis for securing electronic prescriptions.”13  In July 2006, HHS and DEA co-sponsored a public meeting on e-prescribing of controlled substances and solicited input from stakeholders.  At that time, CMS stated that we welcomed an opportunity to work jointly with DEA and industry to integrate DEA e-prescribing requirements related to controlled substances into mainstream industry e-prescribing products.   CMS looks forward to partnering with DEA on this important step to combat fraud and harmful drug diversion, which also would help advance broader HHS and health care stakeholder goals in the public health arena.  

12 72 FR 64905

13 NCVHS Letter, March 4, 2005, Recommended Action 1.1.

Interagency cooperation, working closely together with all interested stakeholders, utilizing current platforms as much as possible, is vital to further growth in e-prescribing.  Toward this end, the Administration supports pilot programs that could identify gaps in current e-prescribing security measures as a useful starting point.  Pilots should be coordinated with other key health care stakeholders to ensure that mainstream solutions are developed.

Conclusion

Thank you for the opportunity to talk about CMS’ role in promoting e-prescribing.  We are committed to ensuring patient safety not only for the Medicare population, but for all Americans.  CMS looks forward to continued work with DEA and others.  I am happy to address any questions or concerns the Committee may have.

Last revised: August 29,2008