Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-18T20:58:45.250Z Has data issue: false hasContentIssue false
  • English
  • Français

CHANGING FACE OF MEDICARE’S NATIONAL COVERAGE DETERMINATIONS FOR TECHNOLOGY

Published online by Cambridge University Press:  11 January 2016

James D. Chambers ,
Matthew D. Chenoweth ,
Junhee Pyo ,
Michael J. Cangelosi  and
Peter J. Neumann
James D. Chambers
Affiliation:
Tufts University School of Medicine, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of [email protected]
Matthew D. Chenoweth
Affiliation:
Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center
Junhee Pyo
Affiliation:
WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Department of Pharmaceutical Science, Utrecht University
Michael J. Cangelosi
Affiliation:
Boston Scientific
Peter J. Neumann
Affiliation:
Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University School of Medicine
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: The Centers for Medicare and Medicaid Services (CMS) issues National Coverage Determinations (NCDs) for medical interventions expected to have a significant impact on Medicare, the health insurance program for US citizens aged 65 years and older and certain people with disabilities under the age of 65 years. The objective of this study was to evaluate NCDs issued from 1999 to 2013 to identify key trends, and to discuss implications for future CMS policy.

Methods: We used the Tufts Medical Center Medicare National Coverage Determination Database to examine characteristics of NCDs from 1999 through 2013. We examined various characteristics of NCDs, including: whether the intervention under review is used for prevention or treatment of disease, the type of intervention considered, evidence limitations cited by CMS, and coverage determination outcome. We evaluated longitudinal trends in categorical and continuous variables in the database, using Cochran-Armitage trend tests and linear regression, respectively.

Results: We found that NCDs increasingly focus on preventive care (p = 0.072), pertain to diagnostic imaging (p = 0.033), and evaluate health education/behavioral therapy interventions (p = 0.051). CMS increasingly cites the lack of relevant outcomes (p = 0.019) and the lack of applicability of study results to the Medicare population (p < 0.001) as evidence limitations. CMS less often restricts coverage to certain population subgroups in NCDs (p < 0.001), but increasingly applies coverage with evidence development policies (p < 0.001).

Conclusions: Identified trends reflect broader changes in Medicare as CMS shifts its focus from treatment to prevention of disease, addresses potentially overutilized technologies, and attempts to issue flexible coverage policies.

Keywords

MedicareNational coverage determinationsMedical technology
Type
Policies
Information
International Journal of Technology Assessment in Health Care , Volume 31 , Issue 5 , 2015 , pp. 347 - 354
Copyright
Copyright © Cambridge University Press 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Centers for Medicare and Medicaid Services. National Health Expenditures 2013 Highlights. Baltimore, MD. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf (accessed March 18, 2015).Google Scholar
2. United States Government Accountability Office. Testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives. 2013 HIGH-RISK UPDATE - Medicare and Medicaid. http://gao.gov/assets/660/652414.txt (accessed March 18, 2015).Google Scholar
3. Centers for Medicare and Medicaid Services. National and local coverage indexes. http://www.cms.gov/medicare-coverage-database/indexes/national-and-local-indexes.aspx (accessed March 18, 2015).Google Scholar
4. Centers for Medicare and Medicaid Services. Medicare Administrative Contractors (MACs). http://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/MedicareAdministrativeContractors.html (accessed March 18, 2015).Google Scholar
5. Chambers, JD, Chenoweth, M, Cangelosi, MJ, et al. Medicare is scrutinizing evidence more tightly for national coverage determinations. Health Aff (Millwood). 2015;34:253–260.Google Scholar
6. Neumann, PJ, Divi, N, Beinfeld, MT, et al. Medicare's national coverage decisions, 1999–2003: Quality of evidence and review times. Health Aff (Millwood). 2005;24:243–254.Google Scholar
7. Neumann, PJ, Kamae, MS, Palmer, JA. Medicare's national coverage decisions for technologies, 1999–2007. Health Aff (Millwood). 2008;27:1620–1631.Google Scholar
8. Tufts Medical Center. The TMC Medicare National Coverage Determinations (NCDs) Database [home page on the internet]. https://www.tuftsmedicalcenter.org/Research-Clinical-Trials/Institutes-Centers-Labs/Center-for-Evaluation-of-Value-and-Risk-in-Health/CEVR-Value-Databases.aspx (accessed March 18, 2015).Google Scholar
9. The Centers for Medicare and Medicaid Services. Medicare coverage database. http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx (accessed March 18, 2015).Google Scholar
10. Chambers, JD, Morris, S, Neumann, PJ, Buxton, MJ. Factors predicting Medicare national coverage: An empirical analysis. Med Care. 2012;50:249–256.Google Scholar
11. Chambers, JD, May, KE, Neumann, PJ. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain. Health Aff (Millwood). 2013;32:1109–1115.Google Scholar
12. Centers for Medicare and Medicaid Services. Decision memo for Implantable Cardioverter Defibrillators (ICDs) (CAG-00157N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=39&NcaName=Implantable+Cardioverter+Defibrillators+%28ICDs%29&DocID=CAG-00157N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
13. Centers for Medicare and Medicaid Services. Decision memo for diabetic peripheral neuropathy with Loss of Protective Sensation (LOPS) (CAG-00059N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=22&NcaName=Diabetic+Peripheral+Neuropathy+with+Loss+of+Protective+Sensation+%28LOPS%29&DocID=CAG-00059N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
14. Centers for Medicare and Medicaid Services. Decision memo for aprepitant for chemotherapy-induced emesis (CAG-00248N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=133&NcaName=Aprepitant+for+Chemotherapy-Induced+Emesis&DocID=CAG-00248N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
15. Centers for Medicare and Medicaid Services. Decision memo for positron emission tomography (FDG) (CAG-00065N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=85&NcaName=Positron+Emission+Tomography+%28FDG%29&DocID=CAG-00065N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
16. Centers for Medicare and Medicaid Services. Decision memo for screening immunoassay fecal-occult blood test (CAG-00180N). Baltimore, MD: Centers for Medicare and Medicaid Services. www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=87&NcaName=Screening+Immunoassay+Fecal-Occult+Blood+Test&DocID=CAG-00180N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
17. Centers for Medicare and Medicaid Services. Decision memo for intensive behavioral therapy for cardiovascular disease (CAG-00424N). http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=248&NcaName=Intensive+Behavioral+Therapy+for+Cardiovascular+Disease&DocID=CAG-00424N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
18. Centers for Medicare and Medicaid Services. Decision memo for lung volume reduction surgery (CAG-00115R). http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=96&NcaName=Lung+Volume+Reduction+Surgery&DocID=CAG-00115R&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
19. Centers for Medicare and Medicaid Services. Decision memo for cardiac rehabilitation programs (CAG-00089R). http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=164&NcaName=Cardiac+Rehabilitation+Programs&NCDId=36&ncdver=3&IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D& (accessed March 18, 2015).Google Scholar
20. U.S. Preventive Services Task Force Grade Definitions Prior to May 2007. http://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions (accessed March 18, 2015).Google Scholar
21. Centers for Medicare and Medicaid Services. Decision memo for smoking & tobacco use cessation counseling (CAG-00241N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=130&NcaName=Smoking+%26+Tobacco+Use+Cessation+Counseling&DocID=CAG-00241N&bc=gAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
22. Centers for Medicare and Medicaid Services. Decision memo for autologous cellular immunotherapy treatment of metastatic prostate cancer (CAG-00422N) Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=247&ver=12&NcaName=Autologous+Cellular+Immunotherapy+Treatment+of+Metastatic+Prostate+Cancer&TimeFrame=7&DocType=All&bc=AgAAYAAAIAAA (accessed March 18, 2015).Google Scholar
23. Medicare: Trends in fees, utilization, and expenditures for imaging services before and after implementation of the Deficit Reduction Act of 2005. Report No.: GAO-08–1102R. http://www.gao.gov/products/GAO-08--1102R (accessed March 18, 2015).Google Scholar
24. Medicare Part B Imaging Services: Rapid spending growth and shift to physician offices indicate need for CMS to consider additional management practices. Report No.: GAO-08–452. http://www.gao.gov/products/GAO-08--452 (accessed March 18, 2015).Google Scholar
25. Centers for Medicare and Medicaid Services. Decision memo for counseling to prevent tobacco use (CAG-00420N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=242&NcaName=Counseling+to+Prevent+Tobacco+Use&DocID=CAG-00420N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
26. Centers for Medicare and Medicaid Services. Decision memo for intensive behavioral therapy for obesity (CAG-00423N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=253&NcaName=Intensive+Behavioral+Therapy+for+Obesity&DocID=CAG-00423N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
27. Centers for Medicare and Medicaid Services. Decision memo for screening for sexually transmitted infections (STIs) and high-intensity behavioral counseling (HIBC) to prevent STIs (CAG-00426N). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Screening%20for%20Sexually%20Transmitted%20Infections%20%28STIs%29%20and%20High-Intensity%20Behavioral%20Counseling%20%28HIBC%29%20to%20prevent%20%28STIs%29&bc=ACAAAAAAIAAA&NCAId=250& (accessed March 18, 2015).Google Scholar
28. Centers for Medicare and Medicaid Services. Decision memo for intensive behavioral therapy for cardiovascular disease (CAG-00424N). http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=248&NcaName=Intensive+Behavioral+Therapy+for+Cardiovascular+Disease&DocID=CAG-00424N&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
29. Patient Protection and Affordable Care Act (PPACA), H.R. 3590. 2010.Google Scholar
30. Faust, HS, Menzel, PT. Prevention vs. treatment: What's the right balance? New York: Oxford University Press; 2012.Google Scholar
31. Cohen, JT, Neumann, PJ, Weinstein, MC. Does preventive care save money? Health economics and the presidential candidates. N Engl J Med. 2008;358:661–663.Google Scholar
32. Chambers, JD, Cangelosi, MJ, Neumann, PJ. Medicare's use of cost-effectiveness analysis for prevention (but not for treatment). Health Policy. 2015;119:156–163.Google Scholar
33. Hutton, J, Trueman, P, Henshall, C. Coverage with evidence development: An examination of conceptual and policy issues. Int J Technol Assess Health Care. 2007;23:425–432.Google Scholar
34. Neumann, PJ, Chambers, JD, Simon, F, Meckley, LM. Risk-sharing arrangements that link payment for drugs to health outcomes are proving hard to implement. Health Aff (Millwood). 2011;30:2329–2337.Google Scholar
35. Sudlow, CL, Counsell, CE. Problems with UK government's risk sharing scheme for assessing drugs for multiple sclerosis. BMJ. 2003;326:388–392.Google Scholar
36. Garattini, L, Casadei, G. Risk sharing agreements: What lessons from Italy? Int J Technol Assess Health Care. 2011;27:169–172.Google Scholar
37. O’Malley, SP, Selby, WS, Jordan, E. A successful practical application of coverage with evidence development in Australia: Medical Services Advisory Committee interim funding and the PillCam Capsule Endoscopy Register. Int J Technol Assess Health Care. 2009;25:290–296.Google Scholar
38. Chambers, JD, Neumann, PJ, Buxton, MJ. Does Medicare have an implicit cost-effectiveness threshold? Med Decis Making. 2010;30:E14–E27.Google Scholar
39. Daniel, GW, Rubens, EK, McClellan, M. Coverage with evidence development for Medicare beneficiaries: Challenges and next steps. JAMA Intern Med. 2013;173:1281–1282.Google Scholar
40. Tunis, SR, Berenson, RA, Phurrough, SE, Mohr, PE. Improving the quality and efficiency of the Medicare program through coverage policy timely analysis of immediate health policy issues. http://www.urban.org/uploadedpdf/412392-Improving-the-Medicare-Program-Through-Coverage-Policy.pdf (accessed April 10, 2015).Google Scholar
41. Centers for Medicare and Medicaid Services. Draft guidance for the public, industry, and cms staff coverage with evidence development in the context of coverage decisions. http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=23 (accessed March 18, 2015).Google Scholar
42. Neumann, PJ, Tunis, SR. Medicare and medical technology–The growing demand for relevant outcomes. N Engl J Med. 2010;362:377–379Google Scholar
43. PCORI. The Patient-Centered Outcomes Research Institute. http://www.pcori.org/ (accessed March 18, 2015).Google Scholar
44. NICE. The National Institute of Health and Care Excellence. http://www.nice.org.uk/ (accessed March 18, 2015).Google Scholar
45. PBAC. Pharmaceutical Benefits Advisory Committee (PBAC). http://www.pbs.gov.au/info/industry/listing/participants/pbac (accessed March 18, 2015).Google Scholar
46. Centers for Medicare and Medicaid Services. Decision memo for electrical bioimpedance for cardiac output monitoring (CAG-00001R2). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=179&NcaName=Electrical+Bioimpedance+for+Cardiac+Output+Monitoring&DocID=CAG-00001R2&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
47. Centers for Medicare and Medicaid Services. Decision memo for implantable defibrillators (CAG-00157R3). Baltimore, MD: Centers for Medicare and Medicaid Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=148&NcaName=Implantable+Defibrillators&DocID=CAG-00157R3&SearchType=Advanced&bc=IAAAAAgACAAAAA%3d%3d& (accessed March 18, 2015).Google Scholar
48. Foote, SB, Wholey, D, Rockwood, T, Halpern, R. Resolving the tug-of-war between Medicare's national and local coverage. Health Aff (Millwood). 2004;23:108–123.Google Scholar
49. Foote, SB, Halpern, R, Wholey, DR. Variation in Medicare's local coverage policies: Content analysis of local medical review policies. Am J Manag Care. 2005;11:181–187.Google Scholar
50. Saret, CJ, Cangelosi, MJ, Chambers, JD, Cohen, JT, Neumann, PJ. Geographic variation in local Medicare coverage for Part B biologics. In the 18th Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) May 2013.Google Scholar
51. Department of Health and Human Services - Office of Inspector General. Local coverage determinations create inconsistency in Medicare coverage. https://oig.hhs.gov/oei/reports/oei-01--11--00500.asp (accessed March 18, 2015).Google Scholar
52. Medicare Payment Advisory Commission. Reducing Medicare complexity and regulatory burden. http://www.medpac.gov/publications/congressional_reports/dec2001RegBurden.pdf (accessed March 18, 2015).Google Scholar
53. U.S. General Accounting Office. Medicare: Divided authority for policies on coverage of procedures and devices results in inequities, GAO-03–175. http://www.gao.gov/products/GAO-03--175 (accessed March 18, 2015).Google Scholar
54. Medicare Prescription Drug, Improvement, and Modernization Act (MMA), Medicare Prescription Drug, Improvement, and Modernization Act (MMA), (2003).Google Scholar
55. Centers for Medicare and Medicaid Services. Medicare administrative contractors. https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/Downloads/MACs-by-State-Feb-2014.pdf 2014 (accessed April 10, 2015).Google Scholar
56. Bailey, PG. Medicare and national coverage. Health Aff (Millwood). 2005;24:295–296.Google Scholar