Federal and State News
WG2 SPL Activities Task Group
Workers' Compensation Guidance
ANSI HITSP
Medicare Information
NCVHS Information
American Recovery and Reinvestment Act
Patient Protection and Affordable Care Act
FDA
Agency for Healthcare Research and Quality
WG2 SPL Activities Task Group
The SPL Activities Task Group reports to WG2 Product Identification and is responsible for monitoring the Federal Drug Administration’s work on the Structured Product Labeling to offer suggestions for improvement/changes. The Guiding Coalition Group, made up of representatives from the drug compendia, the FDA, and pharmacy industry participants, reports to this task group. The Guiding Coalition was formed at the request of the FDA and is the harmonization effort to provide and obtain drug information. The Guiding Coalition Group meets via conference calls between NCPDP Work Group meetings. The SPL Activities Task Group meets face to face during the NCPDP WG meetings to receive and discuss updates on the successes of the the Guiding Coalition.
Click here for the minutes of the SPL Activities TAsk Group meetings.Participation in the Task Group does not require NCPDP membership. This task group continues to look at issues relevant to the SPL and welcomes input. If you would like to participate in the SPL Activities Task Group or have SPL issues that you would like addressed, please contact Patsy McElroy.
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American Recovery and Reinvestment Act
HHS website
NCVHS recommendations on Meaningful Use for Healthcare Information Technology Medicare & Medicaid EHR Incentive Programs.
CMS has posted information on the background, funding, criteria, incentives, and FAQs including a timeline at
http://www.cms.hhs.gov/apps/media/fact_sheets.asp click on June 16, 2009 title: "MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY: TITLE IV OF THE AMERICAN RECOVERY AND REINVESTMENT ACT "
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Patient Protection and Affordable Care Act
H.R. 3590 the Patient Protection and Affordable Care Act
This regulation was created to provide quality, affordable health care for all Americans. View the entire act.
Under PPACA, there are regulations for standards named in HIPAA, for the formation of operating rules entity(ies), for health plan certification, timelines for processes and adoptions.
NCPDP concerns with standards requirements
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Workers' Compensation Guidance
NCPDP's Work Group 16 Property and Casualty/Workers' Compensation, in conjunction with the WG1 Telecommunication Version 5 Frequently Asked Questions Task Group have created guidance for Workers' Compensation claims using the Telecommunication Standard Version 5.1, which is in common use in the pharmacy industry. See Appendix G. Workers' Compensation Recommendations of the Version 5 Editorial document. While most of the guidance for building a Version 5.1 claim is contained in the Telecommunication Standard Specification and Implementation Guide, this document will be updated quarterly as questions come forward that offer more guidance.
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American National Standards Institute (ANSI)
Health Information Technology Standards Panel (HITSP)
The mission of the Healthcare Information Technology Standards Panel is to serve as a cooperative partnership between the public and private sectors for the purpose of achieving a widely accepted and useful set of standards specifically to enable and support widespread interoperability among healthcare software applications, as they will interact in a local, regional and national health information network for the United States. For more information see www.hitsp.org
January 2007 Secretary Leavitt officially accepted HITSP's Interoperability Specifications for his acceptance of thirty (30) consensus standards taking the next step towards development of a nationwide health information network for the United States.
The American Health Information Community (AHIC) 2007 use cases: Consumer Access to Clinical Information, Medications Management, Quality, and Emergency First Responder. The 2008 use cases: Immunization and Response Management, Personalized Healthcare, Public Health Case Reporting, Remote Monitoring, Consultation and Transfers of Care, and Patient Provider Secure Messaging. Contact jkant@himss.org to join a Technical Committee.
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Medicare Information
April 7, 2008 - The Department of Health and Human Services, Centers for Medicare and Medicaid Services have published a file rule for the next set of uniform standards for an electronic prescription drug program. The standards adopted under the rule will apply to all Part D sponsors, as well as to prescribers and dispensers that electronically transmit prescriptions and prescription-related information about Part D covered drugs prescribed for Part D eligible individuals. The rule adopts four standards for use in e-prescribing:
- NCPDP Formulary and Benefits Standard version 1.0
- NCPDP SCRIPT Standard version 8.1 - for Medication History and Fill Status Notification transactions
- National Provider ID
The new e-prescribing requirements will be effective on April 1, 2009.
This final rule on Part D e-prescribing standards (CMS-0016-F/CMS-0018-F) is available at http://www.access.gpo.gov/su_docs/fedreg/a080407c.html
EPRESCRIBING FINAL RULE RELEASED
On November 1, 2005, HHS Secretary Mike Leavitt announced adoption by regulation of a set of standards for the electronic prescription of Part D drugs, which will make the use of prescription drugs easier and safer for Medicare beneficiaries. Foundation standards of NCPDP SCRIPT Version 5.0, ASC X12N 270/271 Version 4010A1, and NCPDP Telecommunication Standard Version 5.1 were named. The rule is published on the CMS website
http://www.cms.hhs.gov/MMAUpdate/ and in the Federal Register on November 7, 2005 http://www.access.gpo.gov/su_docs/fedreg/frcont05.html
MMA EPRESCRIBING PILOT GUIDANCE
Please click for more information.
MEDICARE PRESCRIPTION DRUG BENEFIT
June 2005 NCPDP has released standards guidance for the processing of eligibility and billing claims in Medicare Part D
using the Telecommunication Standard Version 5.1 (required under HIPAA). This guidance provides a standard method for
relaying other insurance coverage information identifiers from the primary payer (PDP) to the pharmacy. Because these
transactions are HIPAA-named, workarounds were necessary to support the relaying of this information. This guidance is available in the
Version 5 Editorial document.See the "Medicare Part D" section. It is very important that industry participants use the guidance outlined in this document for a consistent implementation. This document is updated at least quarterly, so please check back often.
The Facilitator sends TrOOP to the PDP when triggered by the submission of a transaction by a pharmacy to a secondary or
downstream payer. TrOOP may also be updated by payment information routing from the secondary or downstream payer through
the Facilitator to the PDP or directly to the PDP. This update utilizes the Information Reporting transactions, N1, N2, and
N3. Because Information Reporting transactions are not HIPAA-named, business needs are reflected in the Telecommunication
Standard Implementation Guide Version C.1. Version C.1 is published and is available in the Members Only section
Standards Download
January 21, 2005 The Centers for Medicare and Medicaid Services (CMS) released final regulations implementing the new
Medicare prescription drug benefit. There is a CMS press release announcing the release of the regulations and two fact
sheets that explain the final regulations and summarize the changes made from the proposed rule.
Press Release,
Fact Sheet,
Proposed Changes.
The regulations are scheduled to be officially published in the Federal Register on Friday, January 28, 2005 at
http://www.access.gpo.gov/su_docs/fedreg/frcont04.html.
Copies of the final regulations are available now on the CMS website at
http://www.cms.hhs.gov/MMAUpdate/.
The regulations are very long. The Medicare Prescription Drug Benefit regulation is 1,162 pages and a separate regulation
implementing the Medicare Advantage program (formerly Medicare+Choice) is 614 pages.
Part D Websites
The Medicare prescription drug benefit, authorized in the Medicare Prescription Drug, Improvement, and Modernization Act
(MMA) of 2003 provides for catastrophic coverage of drug costs once a beneficiary has reached the statutory threshold of
True Out-of-Pocket (TrOOP) expenses. TrOOP expenses are the costs of prescription drugs that the Beneficiary must pay on
their own because they are not covered by Medicare Part D or any supplemental or third-party payer.
In order to track and report eligibility, and correctly pay for catastrophic drug coverage, CMS contracted for the services
of a TrOOP Facilitator Contractor to NDCHealth. The TrOOP Facilitator Contractor works with CMS, Prescription Drug Plans
(PDP), Medicare Advantage Prescription Drug Plans (MAPD) and carriers of supplemental coverage to coordinate benefits and
track the sources of cost-sharing payments. http://medifacd.ndchealth.com/Home/MediFacD_Home.htm
To learn more about the Medicare Prescription Drug Program, go to http://www.medicare.gov/medicarereform/drugbenefit.asp
NCPDP Letter to CMS Regarding LTC Guidance
In November 2005 the NCPDP adopted the Long-Term Care (LTC) Pharmacy Claims Submission Recommendations For Version 5.1 appendix found in the NCPDP Telecommunication Version 5 Questions, Answers and Editorial Updates document. This appendix provides guidance for the long term care industry based upon the existing definitions in the NCPDP Data Dictionary for the Telecommunication Standard Version 5.1 and supports possible solutions that would allow for consistent technical solutions across plan sponsors and their subcontractors, long term care providers, and vendors nationwide.
The LTC Current Billing Issues Task Group developed a letter to send to CMS requesting their support of the use of this guidance by all participants in delivering Part D benefits to patients in long term care facilities. Click Here for a copy of that letter.
Medicare Program Memorandums
Medicare Program Memorandums and other information can be found at
http://www.cms.hhs.gov/manuals/
Medicare Remit Easy Print (MREP)
CMS has developed free software called Medicare Remit Easy Print (MREP) that gives Medicare physicians/suppliers a tool to read and print a remittance advice (RA) from the HIPAA compliant Health Care Claim Payment/Advice (835) file. The paper output generated by MREP is similar to the SPR format. MREP software information (including how to obtain a free copy) is available on Medicare contractor websites. To learn more about the new MREP software and how to receive the HIPAA 835, physicians and suppliers should contact their Medicare carrier or DMERC. Medicare Part B Electronic Data Interchange (EDI) Helpline phone numbers are available at http://www.cms.hhs.gov/ElectronicBillingEDITrans on the CMS website. To learn more about MREP, see the brochure available at http://www.cms.hhs.gov/MLNProducts/downloads/remit_easy_print.pdf on the CMS website.
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NCVHS Information
Electronic Prescribing
May 2008 NCVHS Based on testimony from the industry, the National Committee on Vital and Health Statistics submitted a recommendation letter to the Secretary of HHS requesting eprescribing updates, specifically for the SCRIPT Version 10.5, especially for long term care, and also to lift the current exemption for eprescribing for long term care. The letter is available at http://www.ncvhs.hhs.gov/
November 2008 - Based on recommendations from participants in NCPDP Work Group 11 ePrescribing and Related Transactions, the recommendation has been made to the National Committee on Vital and Health Statistics (NCVHS) to proceed to the SCRIPT Standard Implementation Guide Version 10.6 by January 2010. SCRIPT Standard Implementation Guide Version 10.6 supports the functionality of previous versions while supporting additional functionality, including needs identified by the long-term care industry.
January 2008 NCPDP presented the following testimony to NCVHS. December 2007 Recommendation letter for SCRIPT 10.5, NCPDP SCRIPT Enhancements, and SCRIPT Modifications.
December 2005 NCPDP presented the following testimony to NCVHS.
Eprescribing Work Items Testimony,
Prior Auth Workflow Task Group Presentation,
Industry Sig Task Group Presentation,
SCRIPT Version 8.1, and
HIPAA Versioning Impact.
July 2005 NCPDP presented the following testimony to NCVHS.
Eprescribing Work Items Testimony
Prior Auth Task Group Presentation
Industry SIG Task Group Presentation
NCPDP-HL7 Eprescribing Mapping Presentation
February 2005 NCPDP presented the following testimony to NCVHS.
Eprescribing Work Items Testimony
Prior Auth Task Group Presentation
RxNorm Task Group Testimony
December 2004 NCPDP Testimony to NCVHS on status
of eprescribing recommendation work items. NCPDP
Testimony to NCVHS on electronic signature.
September 2004 NCVHS recommendations to HHS on electronic prescribing for the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA). The letter is available at
http://www.ncvhs.hhs.gov/.
March 30, 2004 NCPDP representatives testified to NCVHS on e-prescribing. The testimony when available is at
http://www.ncvhs.hhs.gov/
The presentation.
Operating Rules
In July 2010 NCVHS received testimony from the industry on the naming of operating rules entity(ies). NCPDP formally requested to be named an operating rules entity. NCPDP testimony on operating rules.
National Health Plan Identifier
In July 2010 NCVHS received testimony from the industry on the National Health Plan Identifier. Information requested by NCVHS included the perceived need and use of the Plan ID as well as recommendations for the format and content. NCPDP testimony on the National Health Plan ID.
NCPDP's Electronic and Digital Signature Recommendations for an Eprescribing Environment
NCPDP Work Group 11 Prescriber/Pharmacist Interface and Work Group 12 Education - Legislation and Regulation formed a joint
task group in May 2004 to prepare electronic and digital signature recommendations for an eprescribing environment. This
action was in response to the National Committee on Vital and Health Statistics request for our expertise and feedback
regarding this subject. Many NCPDP members and staff testified in 2004 and 2005 to the NCVHS based on the recommendations
of this joint task group. Based on the feedback, the NCVHS was satisfied with the recommendations. The diagram was
submitted in a letter to Secretary Michael Leavitt as part of NCVHS's recommendations. The task group officially disbanded
in March 2005.
Recommendations
Diagram
If you have any questions regarding these documents, please contact
Dan Staniec at Caremark dan.staniec@caremark.com or
Ken Whittemore at SureScripts Ken.Whittemore@surescripts.com.
For NCVHS's recommendations to HHS, see www.ncvhs.hhs.gov
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FDA
FDA Draft Guidance: Standardized Numerical Identification for Prescription Drug Packages
On January 16, 2009 the Food and Drug Administration (FDA) issued Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages; Availability; Request for Comments [Docket No. FDA-2009-D-0001]. The NCPDP response was submitted on April 9, 2009.
For a PDF copy of FDA-2009-D-0001 click here.
For a copy of the draft Guidance for Industry Standards for Securing the Drug Supply Chain -Standardized Numerical Identification for Prescription Drug Packages, click here.
Click here for a copy of NCPDP's responses to the request.
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Agency for Healthcare Research and Quality
AHRQ Releases Report of E-prescribing Standards Expert Meeting
Experts in the field of e-prescribing standards met in February to discuss next steps for three e-prescribing standards that were not ready for adoption by the first generation of e-prescribing pilots funded by the AHRQ and the Centers for Medicare & Medicaid Services beginning in 2005. Experts discussed the technical work needed and additional research and testing required for the RxNorm, Structured and Codified Sig, and Electronic Prior Authorization standards to be recommended for widespread adoption. A summary of the meeting is available here.
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