Federal and State News
Medication Therapy Management
Centers for Medicare and Medicaid Services (CMS) development of the Standardized Format, which consists of three documents: a cover letter, a medication action plan, and a personal medication list. The Standardized Format has been finalized and the three component documents, instructions for implementation, and frequently-asked-questions are available on the CMS website at: http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/MTM.html.
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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 Guiding Coalition.
Click here for the minutes of the SPL Activities Task Group meetings, the spreadsheet of issues, and letters sent to the FDA.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 "
The Office of the National Coordinator for Health Information Technology (ONC) has posted Frequently Asked Questions about the EHR certification program, the standards named in regulation, vendor questions, etc. See http://healthit.hhs.gov/portal/server.pt/community/onc_regulations_faqs/3163 See additional FAQs at the bottom of this same page.
05/2011 NCPDP provided Recommendations to ONC and NCVHS as an initial step to enable the interoperable exchange of patient medication based allergy and drug sensitivity information.
08/2011 NCPDP Recommendations on use of RxNorm, Discharge Prescriptions
09/2011 Medicare Program; Changes to the Electronic Prescribing (eRx) Incentive Program
03/2012 CMS MU Stage 2 Incentive NPRM HHS EHR Standards, Specifications, Certification Criteria NPRM NCPDP Response to Standards NPRM
06/2012 Nationwide Health Information Network: Conditions for Trusted Exchange RFI NCPDP Response
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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
Implementation Resources
Key Features of the Law
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MEDICARE PRESCRIPTION DRUG BENEFIT
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,
Regulations.
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 Transaction Facilitator Contractor to RelayHealth. The Transaction 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. https://medifacd.relayhealth.com/
To learn more about the Medicare Prescription Drug Program, go to https://www.cms.gov/home/medicare.asp
Information about the Transaction Facilitator Financial Information Reporting processing, go to https://medifacd.relayhealth.com/Payers/FIRPayers.html
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
July 2009 – NCVHS Recommendation of SCRIPT 10.6 and lifting of LTC exemption
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.
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Operating Rules
Eligibility and Claim Status transactions
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.In December 2010 NCVHS received further testimony from the recommended operating rules entities. NCPDP December testimony on operating rules.
NCPDP Response to OR Interim Final Rule.
835 and EFT transactions
In December 2010 NCVHS received testimony from entities interested in becoming operating rule entities for electronic remittance advice and electronic funds transfer transactions. Testimony. In March 2011, NCVHS recommended operating rule entities to HHS for 835 and EFT.
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.
Readiness for HIPAA Transactions and Code Sets
In June 2011 NCVHS received testimony from the industry on the readiness of the industry for the HIPAA named transactions - the NCPDP Telecommunication Standard Version D.0, Batch Standard Version 1.2, and Medicaid Subrogation Version 3.0 and the ASC X12 5010 transactions as well as the transition to the ICD-10 code sets. Information requested by NCVHS included the key issues found during impact assessments, implementation strategies, training plans and testing and implementation statuses. NCPDP testimony on the industry readiness.
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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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Office of the Federal Register
The OFR has published a request for comments on a petition to amend their regulations governing the approval of
agency requests to incorporate material by reference into the Code of Federal Regulations. NCPDP's response.
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