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Elizabeth B. Carder-Thompson, all library items

  1. Reed Smith Health Care Reform Review: The Affordable Care Act - Analysis and Implications for DMEPOS Suppliers

    July 07, 2010

    Suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) will be impacted, directly and indirectly, by numerous provisions of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), collectively known as the “Affordable Care Act” or ACA.

  2. Reed Smith Health Care Reform Review: The Affordable Care Act - Analysis and Implications for Drug, Device and Biotech Manufacturers

    June 24, 2010

    In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers.

  3. Reed Smith Health Care Reform Review: Analysis and Implications of Fraud Abuse and Program Integrity Provisions of the Affordable Care Act

    June 03, 2010

    In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. In this analysis, we concentrate on those provisions in the new law that will affect Fraud Abuse and Program Integrity Provisions.

  4. Reed Smith Health Care Reform Review - The Patient Protection and Affordable Care Act as amended by the Reconciliation Act

    April 09, 2010

    On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA), a sweeping measure designed to expand access to health insurance, reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. The President also signed a second bill into law on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which includes a series of “fixes” to the PPACA, including substantive changes to the PPACA’s provisions regarding Medicare prescription drug coverage, Medicare Advantage and fee-for-service payments, Stark law self-referral policy, and Medicaid matching payments, among many others. Within the thousands of pages of the new laws are numerous provisions that will have a direct and material impact on nearly every component of the health care delivery and financing systems in the United States, including health insurers, health care providers, and manufacturers of pharmaceuticals and medical devices, as well as employers, taxpayers, and patients. Moreover, the impact of some of these provisions will be felt immediately, as certain provisions are effective upon enactment, and some have January 1, 2010 effective dates. Reed Smith has prepared a major Alert concentrating on those PPACA provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers.

  5. CMS Prepares to Re-Launch Medicare DMEPOS Competitive Bidding—Tips for Potential Bidders

    May 14, 2009

    Client Alert 2009-166

  6. AdvaMed Issues Revised Code of Ethics on Interactions with Health Care Professionals

    December 19, 2008

    Client Alert 2008-225

  7. The Medicare Improvements for Patients and Providers Act of 2008: Delay and Reform of the Medicare DMEPOS Competitive Bidding Program

    July 28, 2008

    Health Care Alert 2008-04

  8. Expansion of Medicare DMEPOS Competitive Bidding Announced

    January 10, 2008

    Health Care Bulletin HC08-01

  9. Medicare Clinical Trial Policy: CMS Rejects Major Proposed Revisions

    October 26, 2007

    In the face of both substantive and procedural concerns, the Centers for Medicare & Medicaid Services (“CMS”) has decided not to adopt significant changes to the Medicare clinical trial national coverage policy that it had proposed on July 19, 2007. Instead, CMS’s July 9, 2007 final clinical trial coverage policy stands.

  10. Medicare Competitive Bidding Program for Durable Medical Equipment, Prosthetics, Orthotics and Supplies

    May 18, 2007

    Health Care Bulletin HC2007-04

  11. CMS Issues Proposed Rule to Implement Medicare Competitive Bidding Program & Other Payment Reforms for Durable Medical Equipment, Prosthetics, Orthotics, & Supplies

    May 22, 2006

    Health Care Bulletin HC2006-05

  12. OIG Advisory Opinion 06-02: Management Services Arrangements Between DME Suppliers and Physicians

    April 04, 2006

    Health Care Bulletin HC2006-02

  13. Research Misconduct: New Enforcement Actions and Developments

    August 31, 2005

    Health Care Bulletin HC2005-08

  14. California Update: Law on Compliance Programs for Drug and Device Manufacturers Effective July 1, 2005

    May 27, 2005

    Health Care Bulletin HC2005-05

  15. Research Misconduct: A New Area of Focus for Government Enforcement

    May 27, 2005

    Health Care Bulletin HC2005-06

  16. CMS Issues Final Rule to Implement the New Medicare Part D Outpatient Prescription Drug Program

    February 28, 2005

    Health Care Bulletin HC2005-02

  17. New State Laws on Reporting Marketing Expenses of Drug/Device Manufacturers: California and the District of Columbia

    November 29, 2004

    Health Care Bulletin HC2004-20

  18. Office of Inspector General Supplemental Compliance Program Guidance for Hospitals

    July 16, 2004

    Health Care Bulletin HC2004-14

  19. Medco Settlements

    May 13, 2004

    Health Care Bulletin HC2004-09

  20. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    December 11, 2003

    Health Care Bulletin HC2003-21

  21. Vol. VIII, No. 2 (Fall 2003)

    November 24, 2003

    Health Law Monitor

  22. OIG Proposes Clarifications to Exclusionary Rule Prohibiting Excessive Charges

    October 01, 2003

    Health Care Bulletin HC2003-17

  23. House and Senate Pass Separate Versions of Legislation Reforming Medicare and Expanding Medicare Prescription Drug Coverage

    July 18, 2003

    Health Care Bulletin HC2003-16

  24. Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers

    May 15, 2003

    Health Care Bulletin H2003-12

  25. OIG Issues Special Advisory Bulletin on Contractual Joint Ventures

    May 05, 2003

    Health Care Bulletin HC2003-11

  26. CMS Issues Medicare “Inherent Reasonableness” Rule

    December 20, 2002

    Health Care Bulletin HC2002-24

  27. Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers

    November 28, 2002

    Health Care Bulletin HC02-20

  28. HHS Issues HIPAA Privacy Rule Modifications

    August 15, 2002

    Health Care Bulletin HC02-16

  29. New Rule Proposed to Modify the HIPAA Privacy Regulations

    March 26, 2002

    Health Care Bulletin HC02-06

  30. Proposed Rule for “Medicare-Endorsed Prescription Drug Card Assistance Initiative”

    March 14, 2002

    Health Care Bulletin HC02-05

  31. CMS Issues New Policy Allowing Faxed/Electronic CMNs and Orders

    September 24, 2001

    Health Care Bulletin HC 01-12

  32. HCFA “Educational Symposium” on the Use of Evidence-Based Medicine in the Medicare Coverage Decision Process

    May 09, 2001

    Health Care Bulletin HC01-08

  33. Top Ten Legal Issues Looming for HME Suppliers in 2001

    March 01, 2001

  34. HCFA’s Final Stark II Regulations With Comment Period (Phase I)

    February 28, 2001

    Health Care Bulletin HC01-05

  35. Final HIPAA Rule Issued on Privacy Standards for Individually Identifiable Health Information

    January 04, 2001

    Health Care Bulletin HC01-01

  36. Final Rule Establishing DMEPOS Supplier Standards

    November 01, 2000

    Health Care Bulletin HC00-16

  37. HCFA Notice On Medicare Coverage Decision Criteria

    June 05, 2000

    Health Care Bulletin 00-07

  38. OIG Special Fraud Alert: Rental Of Space In Physician Offices By Persons Or Entities To Which The Physician Refers

    March 03, 2000

    Health Care Bulletin 00-02

  39. OIG Compliance Program Guidance For The Durable Medical Equipment, Prosthetics, Orthotics And Supply Industry

    July 07, 1999

    Health Care 99-08

  40. OIG Draft Compliance Guidance For The Durable Medical Equipment, Prosthetics, Orthotics And Supply Industry

    February 19, 1999

    Health Care 99-03

  41. OIG Final Rule On Exclusion Authorities

    September 23, 1998

    Health Care 98-

  42. Office of Inspector General’s Compliance Program Guidance For Home Health Agencies

    August 28, 1998

    Health Care 98-10

  43. OIG Advisory Opinion 98-8: DME Charges “Substantially in Excess”

    July 07, 1998

    Health Care 98-09

  44. HCFA Home Health Agency Surety Bond Final Rule And Medicare “Incentive Program” Final Rule With Comment Period

    June 12, 1998

    Health Care 98-07