eHIT Laws and Regulations
Release of E-Prescribing Pilot Testing Under MMA Report
With input from the National Committee on Vital and Health Statistics (NCVHS), the results of the pilot test were announced in a report to Congress in April 2007 and were the basis for a Notice of Proposed Rule Making proposing additional standards that was published on November 16, 2007.
ASCP and eHIT Coalition Resources and Activities
ASCP Joins with Other National Pharmacy Organizations Announce Launch of Pharmacy e-Health Information Technology Collaborative
—September 29, 2010
ASCP joins with other national pharmacy organizations to launch the Pharmacy e-Health Information Technology Collaborative. The group is a pharmacy-focused group that provides advocacy and education on “the pharmacy profession’s technology needs to ensure that they are addressed and integrated into the framework of the U.S. Health Information Technology (HIT) infrastructure.”
ASCP Files Comments on DEA Interim Final Rule on E-Prescribing of Controlled Substances—May 2010
In March, the Drug Enforcement Administration (DEA) released an interim final rule for the electronic prescribing of controlled substances. The rule provides practitioners with the option of writing prescriptions for controlled substances electronically and also permits pharmacies to receive, dispense, and archive these electronic prescriptions. However, the system and process requirements are unclear for the unique pharmaceutical care management requirements and workflows pertinent to long-term care and other post acute providers (collectively referred to as “LTPAC” providers) such as nursing facilities, hospice, home health care and assisted living communities. Although the interim final rule went into effect June 1, 2010, the DEA did accept public comments on the rule. ASCP sent an individual comment letter (PDF) in addition to a joint letter with the American Society of Health-System Pharmacists, American Pharmacists Association, and National Community Pharmacists Association (PDF). ASCP’s full comments, as well as a summary of the comments (PDF), are available online.
Pharmacy Organizations Send Joint Letter to ONC on a Permanent EHR Certification Program—May 2010
The Department of Health and Human Services' Office of the National Coordinator of Health Information Technology (ONC) recently issued a proposed rule to establish a permanent certification program for purposes of testing and certifying electronic health record (EHR) systems, or other health information technology (HIT) systems. ASCP, along with the Academy of Managed Care Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists, and the National Community Pharmacists Association, submitted joint comments on May 10 to advance the pharmacy profession's vision and opinions about EHR certification. The organizations urged ONC, as it finalizes the rule, to:
Read the pharmacy organizations' joint comment letter here (Word).
ASCP Submits Comments to CMS on "Meaningful Use" of Electronic Health Records—
This rule proposed to define the “meaningful use” of certified Electronic Health Record (EHR) systems and to establish evaluation criteria that facilitate the flow of incentive payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid programs that are meaningful users of EHRs. While long-term care facilities and pharmacies are not yet recognized as eligible entities, both facilities and pharmacies will be working with and exchanging information with eligible professionals and hospitals. ASCP worked with many of the national pharmacy associations (NCPA, APhA, AMCP, ASHP) and the LTPAC HIT Collaborative to develop comment letters on both pharmacy issues as well as LTC issues. Our letter, along with the pharmacy organizations' collaborative letter and the LTC organizations' collaborative letter, are available below:
CMS Resources and Activities
CMS Publishes an Interim Final Rule with Comment to Adopt NCPDP SCRIPT Standard Version 10.—July 1, 2010
CMS published an interim final rule with a comment to adopt NCPDP SCRIPT Standard Version 10.6 on a voluntary basis to be used for e-prescribing for the Medicare Part D electronic
CMS Publishes the 2009 Physician Fee Schedule Payment Final Rule with E-prescribing Exemption to Computer Generated Fax
—November 19, 2008
In the final rule CMS lifted the exemption to the Computer Generated Fax (CGF) exemption for e-prescribing. CMS listed a date of January 1, 2012 for the elimination of the CGF exemption.
Final Rule on E-prescribing published at the Federal Register
—April 7, 2008
In this final rule, CMS adopted 3 additional standards for use in e-prescribing under part D. The final rule adopts uniform standards for medication history, formulary and benefits, and fill status notification (RxFill) for the Medicare Part D electronic prescribing (e- prescribing) drug program as required by section 1860D–4(e)(4)(D) of the Social Security Act (the Act). In addition, CMS adopts the National Provider Identifier (NPI) as a standard for identifying health care providers in e-prescribing transactions. It also finalized the June 23, 2006 interim final rule with comment period that identified the National Council for Prescription Drug Programs (NCPDP) Prescriber / Pharmacist Interface SCRIPT standard, Implementation Guide, Version 8.1 (‘‘NCPDP SCRIPT 8.1’’) as a backward compatible update of the NCPDP SCRIPT 5.0 (‘‘NCPDP SCRIPT 5.0’’), until April 1, 2009.
CMS Incorporates Additional Standards for Notice of Proposed Rule Making
—November 16, 2007
CMS published a Notice of Proposed Rule Making with additional standards based on the results of a pilot test that were reported to Congress. It also proposes the adoption of a standard identifier for providers and dispensers for use in e-prescribing transactions. These standards, based on a previous pilot study, are consistent with the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) objectives of patient safety, quality of care, and efficiencies and cost saving in the delivery of care.
CMS Publishes Interim Final Rule to Adopt NCPDP SCRIPT Standard version 8.1 Voluntarily
—June 23, 2006
CMS published an interim final rule with comment to adopt NCPDP SCRIPT Standard version 8.1 on a voluntary basis to be used for e-prescribing.
Texas Tech Releases White Paper on Benefits of HIT in Long-Term Care
Long-term care (LTC) facilities that successfully implemented electronic health record (EHR) systems reported improved care quality, increased employee satisfaction, and financial benefits in excess of system costs, according to a new report, entitled, "Long-Term Care Facilities Adoption of Electronic Health Record Technology: A Qualitative Assessment of Early Adopters' Experiences." The report, submitted to the Texas Department of Aging and Disability Services, also found that, despite the advantages of EHR adoption for the LTC facilities using them and payers, the systems are not without cost. For facilities operating in a low profitability mode, as most are in Texas, the costs of adopting an EHR system is prohibitive. The likelihood of widespread diffusion in the near term (3 to 5 years) without well-designed policy initiatives and programs is low.
A copy of the report is available here.
Other Resources: 2007-2009
June 15, 2009
ASCP Submits Comments on Electronic Health Records to ONCHIT
This past week ASCP submitted brief comments to the Office of the National Coordinator for Health Information Technology (ONCHIT) regarding electronic health records (EHRs). The "Health Information Technology for Economic and Clinical Health Act'' or the HITECH Act, a section of the American Recovery and Reinvestment Act of 2009, includes provisions to promote the adoption of interoperable health information technology. In order for providers to qualify for incentive payments for HIT implementation as outlined by the HITECH Act, providers will have to meet certain criteria...including meeting the definition of a "meaningful user" of EHRs. There has been much discussion about the definition of "meaningful use." ASCP wants to be sure that any entity using an EHR to e-prescribe can effectively communicate orders to and from long-term care facilities, so comments were submitted to ONCHIT on this topic. In the comments, ASCP suggests that providers' EHR systems should accommodate electronic prescribing in all settings, including long-term care and post acute care, in order for them to qualify as "meaningful users" and receive incentive payments.
E-Prescribing Conference Proceedings and CME/CE Credit
In October 2008, CMS and 34 partner organizations — including ASCP — hosted a meeting about the mechanics of implementing an e-prescribing program in a practice. Audiotapes and slides are now archived online for continuing education credit. The Massachusetts Medical Society and the American Pharmacist Association are pleased to provide Continuing Medical Education (a maximum of 22.5 AMA PRA Category 1 Credits™) and Continuing Education for pharmacists (up to 13.25 hours of continuing education credit (1.325 CEUs). Click here to view the presentations and hear the audiotapes of the program. There are no registration or certificate fees.
Medicare’s Practical Guide to the E-Prescribing Incentive Program
This guide from the Centers for Medicare & Medicaid Services (CMS) explains the e-prescribing incentive program, how eligible professionals can participate, and how to choose a qualified e-prescribing system.
CMS Releases Final Rule on Computer-Generated Faxes
In their Final Rule, CMS extended the allowance for using computer-generated faxes through December 31, 2011. Starting January 1, 2012, entities transmitting prescriptions or prescription-related information will no longer be allowed to use computer-generated facsimiles, but will instead be required to use the NCPDP SCRIPT Standard. Regarding applicability to the long-term care setting, the Final Rule stated the following:
"Long term care facilities were specifically exempted from the requirement to use the adopted standards in e-prescribing under Medicare Part D due to their unique workflows and complexities associated with prescribing for patients in long-term care settings. This exemption remains in effect for long term care faculties. Therefore, long-term care facilities may continue to use computer-generated facsimiles, and such facilities will continue to be exempt from the requirement to use the NCPDP SCRIPT Standard in prescription transactions between prescribers and dispensers where a non-prescribing provider is required by law to be a part of the overall transaction process."
ASCP's Comments on draft gaps/extensions to Medication Management Use Case
ONCHIT proposes gaps/extensions to be added to Medication Management Use Case
Electronic Medication Administration Record (eMARs)
Legal analysis prepared for ASCP regarding the provision of electronic medication administration record (eMAR) systems by pharmacies to facilities, "Providing eMAR Systems to Care Facilities: Running a Kickback Risk?"
New Financial Incentives for Physicians Who ePrescribe
Section 132 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPAA) authorized a new incentive program for eligible professionals who are successful electronic prescribers (as defined by MIPPA). The e-prescribing incentive amount is based on the Secretary’s estimate (based on claims submitted not later than 2 months after the end of the reporting period) of the allowed charges for all such Physician Fee Schedule (PFS)-covered professional services furnished by the eligible professional during the reporting period. The e-prescribing incentive percent amount for reporting years 2009 - 2010 is 2.0 percent; for reporting years 2011 - 2012 is 1.0 percent; and for reporting year 2013 it is 0.5 percent. It is still unclear whether physicians providing service to long-term care residents will be eligible for this incentive program. Click here to view the CMS Fact Sheet on the ePrescribing incentives under MIPAA.
April 2008 - CMS finalizes Medicare Part D ePrescribing Standards
January 2008 - ASCP Comments on CMS Proposed ePrescribing Final Standards
December 4, 2007 - SureScripts Releases "National e-Prescribing Progress Report"
November 2007 - CMS Releases Proposed Standards for “Medication History” and “Formulary and Benefits” Transactions/Messages in E-Prescribing
CMS released a Notice of Proposed Rule Making (NPRM) announcing a proposal to adopt the ‘Formulary and Benefits’ and ‘Medication History’ e-prescribing standards for the Medicare Part D prescription drug program. This proposed rule also calls for industry comments on several matters, including the feasibility of adopting a standard for the “Fill Status” message/transaction. The standard for ‘Formulary and Benefits’ allows prescribers to see up front which drugs are covered under a beneficiary’s Medicare drug benefit plan as well as a list of alternative drugs. With ‘Medication History,’ providers will know at the point of care which drugs have been prescribed and claimed by their patients. Comments are due to CMS on the proposed rule by January 15, 2008 and should be submitted online.
ASCP will be submitting comments.
November 2007 – CMS Releases Final Rule (with another comment period) for Eliminating the Exemption for Computer-Generated Faxes
The FAX exemption issue is discussed on pages 640–652 of the Final Rule PDF. Here is an excerpt:
“Comment: Some commenters were confused as to whether the computer generated fax exemption would affect the exemption in the long term care setting, and requested that we clarify that prescribers and dispensers in the long term care setting were exempt from the requirement to use NCPDP SCRIPT despite the amendment of the exemption of the computer-generated faxes.
Response: Our amendment of the exemption for computer-generated faxes does not apply at this time to the long term care industry as defined under Medicare Part D. At the time the CY 2008 PFS proposed rule (72 FR 38194) was published in the Federal Register, the long term care industry exemption for using adopted standards in e-prescribing (as contained in the November 7, 2005 final rule (70 FR 67568)) was, and remains, in place. Based on the comments we received, we are finalizing an amendment of the exemption for computer-generated faxes.”
August 2007 – ASCP Comments on CMS Proposed Rule for Eliminating the Exemption for Computer-Generated Faxes
July 2007 – CMS Releases Proposed Rule for Eliminating the Exemption for Computer-Generated Facsimiles of Prescriptions Under E-Prescribing Rule
The purposes of this proposed rule is to increase adoption of electronic-prescribing. Under the current CMS e-prescribing rule, entities that transmit prescriptions using computer-generated faxes are exempt from the requirement that they comply with federal e-prescribing standards. The July ‘07 proposed rule would eliminate this exemption thus requiring entities using such fax technology to begin transmitting prescriptions electronically with software that uses established e-prescribing standard transactions. Long-term care was exempted from the initial, foundation e-prescribing standards named by CMS due to limited use of the transaction in that setting, but this will change in the future as the e-prescribing standards are edited to accommodate the nuances of the long-term care setting. It is unclear whether the new proposed rule for computer-generated faxes applies to long-term care, but ASCP asks for that clarification in our comments to CMS.
Joint letter from several LTC associations, including ASCP, to ONCHIT about Medication Management Use Cases – including the LTC-Specific Medication Management Scenario collaboratively developed by representatives from each LTC association.
ASCP's Comments to ONCHIT on Draft Detailed Use Cases
ONCHIT Proposes Medication Management Use Cases
April 2007 - Findings from E-Prescribing Pilots Released
The National Opinion Research Center (NORC) at the University Of Chicago recently sent to the Agency for Healthcare Research and Quality (AHRQ) an Interim Report of the Findings from the Evaluation of E-Prescribing Pilot Sites. Based on these results of the five pilot projects that tested standards to support the adoption of e-prescribing, HHS Secretary Mike Leavitt provided a Report to Congress (RTC) on April 17, 2007. The RTC indicates that, of those tested, standards for formulary and benefits, medication history, and fill status notification are ready for Part D implementation. Also, the RTC includes evidence that with some adjustments, e-prescribing can work successfully in long-term care setting.
November 7, 2005
CMS Releases FINAL Rule for Implementation of E-Prescribing under MMA
"E-prescribing: Will long-term care be ready?" The Consultant Pharmacist
April 4, 2005
ASCP Comments on CMS Proposed Rules for Implementation of E-Prescribing Program in MMA
January 27, 2005
CMS Releases Proposed Rules for Implementation of E-prescribing Program in MMA
Office of the National Coordinator for Health Information Technology (ONCHIT) Medication Management Use Cases
In January 2007, the American Health Information Community (AHIC) approved a recommendation to develop a use case that addresses medication management. The Medication Management Use Case, released through the Office of the National Coordinator for Health Information Technology (ONCHIT) within the Department of Health and Human Services, focuses on patient medication and allergies information exchange, and the sharing of that information between consumers, clinicians (in multiple sites and settings of care), pharmacists, and organizations that provide health insurance and provide pharmacy benefits. It describes case scenarios for inpatient hospital and for the ambulatory/community setting. In August 2008, ONCHIT released a draft version of "gaps and extensions" to the Medication Management Use Case. Thanks to feedback from numerous long-term care organizations, including ASCP, a medication management scenario specific to the long-term care setting was included in the draft document. Also included was the role of the consultant pharmacist.