Medicare covers the majority of FDA-approved devices and part B drugs, but restrictions and discrepancies remain

Health Affairs

Volumn 32, Issue 6, 2013, Pages 1109-1115

  Chambers, James D ^a,b   May, Katherine E ^a   Neumann, Peter J ^a,b  

^a TUFTS MEDICAL CENTER   (United States)

^b TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL STUDY; COMORBIDITY; DEVICE APPROVAL; DISEASE SEVERITY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE QUALITY; HEALTH INSURANCE; HEALTH PROGRAM; HEALTH SERVICE; HUMAN; MARKETING; MEDICARE; STANDARD;

MEDICAL TECHNOLOGY; MEDICARE; PHARMACEUTICALS;

CENTERS FOR MEDICARE AND MEDICAID SERVICES (U.S.); DATABASES, FACTUAL; DEVICE APPROVAL; DRUG APPROVAL; EQUIPMENT AND SUPPLIES; FINANCING, GOVERNMENT; HUMANS; INSURANCE COVERAGE; PRESCRIPTION DRUGS; REIMBURSEMENT MECHANISMS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84879271963     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2012.1073     Document Type: Article

References (23)

1. For Medicare Part D (most outpatient) prescription drugs, coverage decisions are made by private plans that contract with the program.
2. National Center for Health Statistics. Health, United States, 2009: with special feature on medical technology [Internet]. Hyattsville (MD): NCHS; [cited 2013 Mar 29]. Available from: http://www.cdc.gov/ nchs/data/hus/hus09.pdf
3. Kaiser Family Foundation. Health care costs: a primer: key information on health care costs and their impact [Internet]. Menlo Park (CA): KFF; 2012 May [cited 2013 May 10]. Available from: http://kaiserfamily foundation.files.wordpress.com/2013/01/7670-03.pdf
4. CMS.gov. Factors CMS considers in opening a national coverage determination [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2006 Apr 11 [cited 2013 May 2]. Available from: http://www.cms.gov/medicarecoverage- database/details/medicare-coverage-document-details .aspx?MCDId=6
5. Tufts Medical Center. The TMC Medicare National Coverage Determinations (NCDs) Database [home page on the Internet]. Boston (MA): The Center; [cited 2013 May 2]. Available from: http://icrhps.tuftsmedicalcenter.org/research/cevr/medicarencd.asp
6. Chambers JD, Morris S, Neumann PJ, Buxton MJ. Factors predicting Medicare national coverage: an empirical analysis. Med Care. 2012; 50(3):249-56.
7. Chambers JD, Neumann PJ, Buxton MJ. Does Medicare have an implicit cost-effectiveness threshold? Med Decis Making. 2010;30(4):E14-27.
8. Neumann PJ, Tunis SR. Medicare and medical technology-the growing demand for relevant outcomes. N Engl J Med. 2010;362(5):377-9.
9. Neumann PJ, Kamae MS, Palmer JA. Medicare's national coverage decisions for technologies, 1999-2007. Health Aff (Millwood). 2008;27(6): 1620-31.
10. To access the Appendix, click on the Appendix link in the box to the right of the article online.
11. For the list of the compendiums, see CMS.gov. Compendia 1861 (t)(2)-anti-cancer [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; [last modified 2012 Nov 9; cited 2013 May 2]. Available from: https://www .cms.gov/Medicare/Coverage/CoverageGenInfo/compendia.html
12. The Heartsbreath Test for heart transplant rejection was approved with a humanitarian device exemption. This exemption is required for a humanitarian use device-that is, a device intended for conditions that affect fewer than 4,000 patients annually. A humanitarian device exemption is similar to a premarket approval application, but in the former case, the device is exempt from the effectiveness requirements. CMS did not cover the Heartsbreath Test.
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16. Food and Drug Administration. Vaccines, blood and biologics: biologics license applications (BLA) process (CBER) [Internet]. Silver Spring (MD): FDA; [last updated 2010 Feb 13; cited 2013 May 2]. Available from: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplications BLAProcess/default.htm
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22. CMS.gov. Decision memo for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAG-00085R7) [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2009 Dec 9 [cited 2013 May 2]. Available for download from: http://www.cms.gov/medicare-coveragedatabase/downloads/downloadabledatabases. aspx
23. CMS.gov. Decision memo for bariatric surgery for the treatment of morbid obesity (CAG-00250R) [Internet]. Baltimore (MD): Centers for Medicare and Medicaid Services; 2006 Feb 21 [cited 2013 May 2]. Available for download from: http://www.cms.gov/medicare-coveragedatabase/downloads/downloadabledatabases. aspx