Can coverage be rescinded when negative trial results threaten a popular procedure? The ongoing saga of vertebroplasty

Health Affairs

Volumn 30, Issue 12, 2011, Pages 2269-2276

  Wulff, Katharine Cooper ^a   Miller, Franklin G ^b   Pearson, Steven D ^b  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; BONE CEMENT;

ANALGESIA; ARTICLE; COMPARATIVE EFFECTIVENESS; CONFLICT OF INTEREST; DISABILITY; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; HEALTH CARE POLICY; HEALTH INSURANCE; HUMAN; MEDICAL PRACTICE; METHODOLOGY; NEGATIVE FEEDBACK; PERCUTANEOUS VERTEBROPLASTY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHAM PROCEDURE; UNITED STATES; VERTEBRA FRACTURE;

COMPARATIVE EFFECTIVENESS RESEARCH; EVIDENCE-BASED MEDICINE; HUMANS; INSURANCE COVERAGE; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; VERTEBROPLASTY;

EID: 84855714220     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2011.0159     Document Type: Article

References (28)

1. Ratner R, Eden J, Wolman D, Greenfield S, Sox H, editors. Initial national priorities for comparative effectiveness research. Washington (DC): Institute of Medicine; 2009.
2. Jensen ME, Dion JE. Vertebroplasty relieves osteoporosis pain. Diagn Imaging (San Franc). 1997;19(9): 68,71-2.
3. Evans AJ, Jensen ME, Kip KE, DeNardo AJ, Lawler GJ, Negin GA, et al. Vertebral compression fractures: pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty retrospective report of 245 cases. Radiology. 2003; 226(2):366-72.
4. Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of clinical studies. Spine. 2006; 31(17):1983-2001.
5. McGraw JK, Lippert JA, Minkus KD, Rami PM, Davis TM, Budzik RF. Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up. J Vasc Interv Radiol. 2002;13(9 Pt 1):883-6.
6. Centers for Medicare and Medicaid Services. LCD for percutaneous vertebroplasty (L12263) [Internet]. Baltimore (MD): CMS; 2010 [updated 2010 Mar 1; cited 2011 Jul 21]. Available from: http://coverage.cms.fu.com/mcd_archive/viewlcd.asp?lcd_id=12263&lcd_version=10&show=all [To access this document, it is necessary to accept its terms of use, on the first screen that appears before content is delivered.]
7. Gray DT, Hollingworth W, Onwudiwe N, Jarvik JG. Costs and state-specific rates of thoracic and lumbar vertebroplasty, 2001-2005. Spine. 2008;33(17):1905-12.
8. Grady D. Studies question using cement for spine injuries. New York Times. 2009 Aug 6; Sect. A:18.
9. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wried C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. New Engl J Med. 2009;361(6):557-68.
10. Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009; 361(6):569-79.
11. Society of Interventional Radiology. Commentary on vertebroplasty and the August studies in the New England Journal of Medicine. Fairfax (VA): Society of Interventional Radiology; 2009 Nov 24.
12. North American Spine Society. Newly released vertebroplasty RCTs: a tale of two trials [Internet]. Burr Ridge (IL): NASS; 2009 Oct 13 [cited 2010 Oct 26]. Available from: http://www.spine.org/Documents/NASSComment_on_Vertebroplasty.pdf
13. Aetna. Clinical payment, coding, and policy changes. Aetna OfficeLink Updates: north central region [serial on the Internet]. Hartford (CT): Aetna; 2009 Dec [cited 2010 Jun 2]. Available from: http://www.aetna.com/provider/data/OLU_NC09v5.pdf
14. Henry R. Medicare coverage for erythropoiesis-stimulating agents: the perfect storm. Interview (part 1) with Samuel M. Silver. American Health and Drug Benefits [serial on the Internet]. 2008 May [cited 2011 Nov 10]. Available from: http://www.ahdbonline.com/feature/medicarecoverage-erythropoiesisstimulating-agents-perfect-storm
15. Centers for Medicare and Medicaid Services. Superseded draft Local Coverage Determination (LCD) for vertebroplasty, vertebral augmentation; percutaneous (DL24383). Baltimore (MD): CMS; 2010.
16. Beninati JF. Re: Draft LCD DL2483: Vertebroplasty, vertebral augmentation; percutaneous [Internet]. Fargo (ND): Society of Interventional Radiology, American College of Radiology; 2010 Sep 3 [cited 2011 Nov 10]. Available from: http://www.sirweb.org/misc/Noridian/SIR_Comment_Letter_Noridian.pdf
17. American Academy of Orthopaedic Surgeons. The treatment of symptomatic osteoporotic spinal compression fractures: guideline and evidence report [Internet]. Rosemont (IL): AAOS; 2010 [cited 2010 Oct 26]. Available from: http://www.aaos.org/Research/guidelines/SCFguideline.pdf
18. Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010; 376(9746):1085-92.
19. Kallmes D, Buchbinder R, Jarvik J, Heagerty P, Comstock B, Turner J, et al. Response to "Randomized vertebroplasty trials: bad news or sham news?" Am J Neuroradiol. 2009;30(10):1809-10.
20. Buchbinder R, Osborne RH, Kallmes D. Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty. Med J Australia. 2010;192(6): 338-41.
21. Denaro V, Longo UG, Denaro L. Vertebroplasty versus conservative treatment for vertebral fractures. Lancet. 2010;376(9758):2071.
22. Van Der Weyden MB. Vertebroplasty, evidence, and professional protest. Med J Australia. 2010; 192(6):301-2.
23. Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare's "coverage with evidence development." Health Aff (Millwood). 2006;25(5):1218-30.
24. Gangi A, Clark WA. Have recent vertebroplasty trials changed the indications for vertebroplasty? Cardiovasc Inter Rad. 2010;33(4): 677-80.
25. Pearson SD. From better evidence to better care: using comparative effectiveness research to guide practice and policy. In: Implementing comparative effectiveness research: priorities, methods and impact. Washington (DC): Brookings Institution; 2009. p. 55-82.
26. Miller FG, Kallmes DF. The case of vertebroplasty trials: promoting a culture of evidence-based procedural medicine. Spine. 2010;35(23): 2023-6.
27. Gray BH, Gusmano MK, Collins S. AHCPR and the changing politics of health services research. Health Aff (Millwood). 2003;22:w3-283-307. DOI: 10.1377/hlthaff.w3.283.
28. Keyhani SKA, Mann M, Korenstein D. A new independent authority is needed to issue national health care guidelines. Health Aff (Millwood). 2011;30(2):256-65.