Regulatory Issues

  • Comments to HHS on HPID and ICD-10 Extension Proposed Rule

    May 17, 2012
      May 17, 2012 Centers for Medicare and Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re: File Code CMS-0040-P RIN 0938-AQ13 Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for ICD-10-CM andContinue Reading »...
  • Comments Regarding Taxable Medical Devices

    May 07, 2012
      May 7, 2012 Steven T. Miller Deputy Commissioner for Services and Enforcement Internal Revenue Service 1111 Constitution Avenue, NW Washington, DC Submitted electronically via www.regulations.gov (IRS REQ-i 13770-JO) Re:       Taxable Medical  Devices;  CC:PA:I2PD:PR  (REC—113770-10). Dear Deputy Commissioner Miller: On behalf of the American Clinical Laboratory Association (“ACLA”), I am pleased to provide these comments in connection with the Internal Revenue Service’s (“IRS”) Notice of ProposedContinue Reading »...
  • Comments on MU Stage 2

    May 04, 2012
      May 4, 2012 Ms. Marilyn Tavenner, Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attn: CMS-0044-P P.O. Box 8013 Baltimore, Maryland 21244-8013 RE: RIN 0938-AQ84: Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2 Dear Ms. Tavenner: The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’Continue Reading »...
  • Comments on EHR Certification 2014 Edition

    May 04, 2012
      May 4, 2012 Dr. Farzad Mostashari, National Coordinator for Health Information Technology Office of the National Coordinator for Health Information Technology Department of Health and Human Services Attn: 2014 Edition EHR Standards and Certification Criteria Proposed Rule Hubert H. Humphrey Building, Ste. 729D 200 Independence Avenue SW Washington, DC 20201 RE: RIN 0991-AB82: Health Information Technology: Standards, Implementation Specifications, and Certification Criteria forContinue Reading »...
  • Letter to Reps Kind and Price Regarding Health Information Technology Reform Act

    March 14, 2012
      March 14, 2012 The Honorable Ron Kind 1406 Longworth House Office Building Washington, DC 20515 The Honorable Tom Price 403 Cannon House Office Building Washington, DC 20515 Dear Congressmen Kind and Price: On behalf of the American Clinical Laboratory Association (ACLA), I am writing in support of the Health Information Technology Reform Act, HR 4066, which seeks to exclude pathologists from incentive paymentsContinue Reading »...
  • Comments Regarding Sunshine Rule

    February 17, 2012
      February 17, 2012 Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS—5060—-P Mail Stop C4—26—05 7500 Security Boulevard Baltimore, MD 21244-1850 RE: CMS-5060-P Transparency Reports and Reporting of Physician Ownership or Investment Interests Dear Acting Administrator Tavenner: The American Clinical Laboratory Association (ACLA) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS)Continue Reading »...
  • Comments on J11 Draft LCD for Molecular Diagnostic Tests

    January 16, 2012
      January 16, 2012 Dr. Elaine Jeter Medical Director Palmetto GBA (J11 MAC) P.O. Box 100190 Columbia, South Carolina 29202 RE: Palmetto GBA Draft Local Coverage Determination (LCD) for Molecular Diagnostic Tests (MDT) (DL 32394) Dear Dr. Jeter: The American Clinical Laboratory Association (“ACLA”) hereby submits comments on Palmetto GBA’s (“Palmetto’s”) Draft Local Coverage Determination (“LCD”) for Molecular Diagnostic Tests.1 ACLA is an associationContinue Reading »...
  • Letter to CMS Regarding Saturation Biopsy

    December 10, 2011
        December 10, 2011   Mr. Marc Hartstein, Acting Director Hospital and Ambulatory Policy Group Center for Medicare Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244   Dear Mr. Hartstein:   On behalf of the American Clinical Laboratory Association (“ACLA”), I am writing to express our concerns about CMS’s recent actions with respect to HCPCS code G0416, which isContinue Reading »...
  • Letter to Chairman Camp and Ranking Member Levin Regarding TC “Grandfather” Provision

    December 07, 2011
      December 7, 2011 The Honorable Dave Camp Chairman House Committee on Ways and Means Washington, DC 20515 The Honorable Sandy Levin Ranking Member House Committee on Ways and Means Washington, DC 20515 Dear Chairman Camp and Ranking Member Levin: The undersigned organizations, representing laboratories, hospitals, laboratory professionals, physicians, and the patients we serve, urge you to extend an expiring provision that would ensureContinue Reading »...
  • Comment Letter on Palmetto LCD for Molecular Diagnostic Tests

    December 02, 2011
        December 2, 2011   Dr. Elaine Jeter, Medical Director Mr. Michael Barlow, Vice President Palmetto GBA (J1 MAC) P.O. Box 100190, AG 300 Columbia, South Carolina 29202-3190   RE: Palmetto GBA Draft Local Coverage Determination (LCD) for Molecular Diagnostic Tests (MDT) (DL 32288)   Dear Dr. Jeter and Mr. Barlow:   The American Clinical Laboratory Association (“ACLA”) hereby submits comments on PalmettoContinue Reading »...
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