News

  • 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 »...
  • ACLA Urges Health Subcommittee to Adopt Provisions on User-Fees and Laboratory- Developed Tests

    May 07, 2012
    Washington DC – The American Clinical Laboratory Association today urged the House Energy and Commerce Health Subcommittee to approve provisions in its device user-fee legislation that would allow HHS to waive user fees for clinical laboratories and lab-developed tests (LDTs), and that would further require FDA to notify Congress 60 days prior to issuing a guidance on the regulation of LDTs. ACLA conveyed itsContinue Reading »...
  • Letter to Chairman Pitts and Ranking Member Pallone Regarding MDUFA

    May 07, 2012
      May 7, 2012   The Honorable Joe Pitts Chairman Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2125, Rayburn House Office Building Washington, DC 20515 The Honorable Frank Pallone, Jr. Ranking Member Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2322-A, Rayburn House Office Building Washington, DC 20515   Dear Chairman Pitts and Ranking MemberContinue 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 »...
  • Comments on Overpayments Proposed Rule

    April 16, 2012
      April 16, 2012 Ms. Marilyn Tavenner, Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-6037-P P.O. Box 8013 Baltimore, Maryland 21244-8013 RE: RIN 0938-AQ58: Medicare Program; Reporting and Returning Overpayments Dear Ms. Tavenner, The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (“CMS’s” or “the agency’s”)Continue Reading »...
  • AIM Coalition Welcomes Health Affairs Study on Urologist “Self-Referral” of Surgical Pathology Services

    April 10, 2012
      Study by Georgetown’s Jean Mitchell says self-referral is increasing billings for prostate biopsy pathology evaluations, but not improving cancer detection Washington DC – The Alliance for Integrity in Medicare (AIM)—a broad coalition of medical specialty, laboratory, radiation oncology, and medical imaging groups—today applauded publication of a new study which focuses on the practice of self-referral among urologists who conduct prostate biopsy evaluations inContinue Reading »...
  • New Study On Self-Referral Labs: More Tests, Higher Costs, Fewer Cancer Detections

    April 09, 2012
     CAP Urges Immediate Action to Close In-office Loophole in Federal Law NORTHFIELD, Ill. — A new study by researchers at Georgetown University reveals that the practice of ordering tests from pathology labs in which treating physicians have a financial stake resulted in increased utilization, higher Medicare spending, and lower rates of cancer detection. The independent study was published today in Health Affairs and ledContinue Reading »...
  • ACLA Lauds New Health Affairs Study Finding Medicare Costs Rise and Fewer Cancers Are Detected When Physicians Self-Refer for Prostate Cancer Surgical Pathology Services

    April 09, 2012
    Study demonstrates physicians’ financial self-interest may drive unwarranted procedures and unnecessary Medicare spending; highlights the need for Congress to end legal loophole permitting self-referral of surgical pathology services. Washington, DC – The American Clinical Laboratory Association (ACLA) today welcomed a new study published in Health Affairs providing compelling evidence of the increase in government health care spending that results from urologists performing prostate biopsiesContinue Reading »...
  • Comments Regarding Appropriate Use of Clinical Laboratory Testing

    April 04, 2012
      April 4, 2012 ACLA Comments on Choosing Wisely and Appropriate Use of Clinical Laboratory Testing Statement: The American Clinical Laboratory Association welcomes the Choosing Wisely effort and is now reviewing the report. We applaud continued efforts by physicians and medical groups to bring their expertise and evidence to bear in the effort to encourage appropriate utilization of medical testing. We note that mostContinue Reading »...