161 related articles for article (PubMed ID: 34056780)
1. The problematic lag between FDA approval of medical devices and CMS coverage.
Knight BP; Deering TF; Gold MR; Mittal S; Singh JP
J Cardiovasc Electrophysiol; 2021 Jul; 32(7):1801-1802. PubMed ID: 34056780
[No Abstract] [Full Text] [Related]
2. Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.
Neumann PJ; Crummer E; Chambers JD; Tunis SR
Milbank Q; 2023 Dec; 101(4):1047-1075. PubMed ID: 37644739
[TBL] [Abstract][Full Text] [Related]
3. Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016: A cross-sectional study.
Roginiel AC; Dhruva SS; Ross JS
Medicine (Baltimore); 2018 Oct; 97(40):e12715. PubMed ID: 30290675
[TBL] [Abstract][Full Text] [Related]
4. Will CMS Find Aducanumab Reasonable and Necessary for Alzheimer Disease After FDA Approval?
Schulman KA; Greicius MD; Richman B
JAMA; 2021 Aug; 326(5):383-384. PubMed ID: 34279572
[No Abstract] [Full Text] [Related]
5. Authority of Medicare to Limit Coverage of FDA-Approved Products: Legal and Policy Considerations.
Daval CJR; Kesselheim AS
JAMA Intern Med; 2023 Sep; 183(9):999-1004. PubMed ID: 37505487
[TBL] [Abstract][Full Text] [Related]
6. Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.
Zinn AM; Allen JC; Hacker CS
Health Aff (Millwood); 2012 Oct; 31(10):2304-13. PubMed ID: 23048112
[TBL] [Abstract][Full Text] [Related]
7. Include Payers in Your Product Development and Clinical Use Processes.
Schaum KD
Adv Wound Care (New Rochelle); 2020 Nov; 9(11):632-635. PubMed ID: 32311305
[TBL] [Abstract][Full Text] [Related]
8. CMS Will Cover Alzheimer Drugs With Traditional FDA Approval.
Harris E
JAMA; 2023 Jul; 330(1):14. PubMed ID: 37314825
[No Abstract] [Full Text] [Related]
9. Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program.
Moneer O; Rathi VK; Johnston JL; Ross JS; Dhruva SS
JAMA Cardiol; 2023 Dec; 8(12):1174-1181. PubMed ID: 37878306
[TBL] [Abstract][Full Text] [Related]
10. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.
Chambers JD; May KE; Neumann PJ
Health Aff (Millwood); 2013 Jun; 32(6):1109-15. PubMed ID: 23733986
[TBL] [Abstract][Full Text] [Related]
11. Potential legal barriers to increasing CMS/FDA collaboration: the law of trade secrets and related considerations.
Wang SS; Smith JJ
Food Drug Law J; 2003; 58(4):613-27. PubMed ID: 15027453
[No Abstract] [Full Text] [Related]
12. Using the MADIT II criteria for implantable cardioverter defibrillators-what is the role of the Food and Drug Administration approval?
Barold HS
Card Electrophysiol Rev; 2003 Dec; 7(4):443-6. PubMed ID: 15071272
[TBL] [Abstract][Full Text] [Related]
13. Current and future state of FDA-CMS parallel reviews.
Messner DA; Tunis SR
Clin Pharmacol Ther; 2012 Mar; 91(3):383-5. PubMed ID: 22343814
[TBL] [Abstract][Full Text] [Related]
14. Medicare program; withdrawal of coverage of certain investigational intraocular lenses.--HCFA. Final notice.
Fed Regist; 1991 Apr; 56(83):19874-9. PubMed ID: 10170736
[TBL] [Abstract][Full Text] [Related]
15. Satisfying the requirements of the Food and Drug Administration and Centers for Medicare and Medicare Services.
Smith JJ; Henderson JA
J Am Coll Radiol; 2008 Mar; 5(3):189-92. PubMed ID: 18312966
[TBL] [Abstract][Full Text] [Related]
16. Medicare's New Device-Coverage Pathway - Breakthrough or Breakdown?
Rathi VK; Johnston JL; Ross JS; Dhruva SS
N Engl J Med; 2021 Mar; 384(12):e43. PubMed ID: 33691059
[No Abstract] [Full Text] [Related]
17. Transplant recipients are vulnerable to coverage denial under Medicare Part D.
Potter LM; Maldonado AQ; Lentine KL; Schnitzler MA; Zhang Z; Hess GP; Garrity E; Kasiske BL; Axelrod DA
Am J Transplant; 2018 Jun; 18(6):1502-1509. PubMed ID: 29446874
[TBL] [Abstract][Full Text] [Related]
18. Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS.
Califf RM; Sherman RE; Slavitt A
JAMA; 2016 Dec; 316(23):2485-2486. PubMed ID: 27820637
[No Abstract] [Full Text] [Related]
19. The disconnect between the HCFA and the FDA.
Firth BG
J Invasive Cardiol; 2001 Feb; 13(2):136-8; discussion 158-70. PubMed ID: 11176025
[No Abstract] [Full Text] [Related]
20. CMS national coverage determinations for devices.
Brock JA; Jensen TS; Jacques LB
Health Aff (Millwood); 2013 Jan; 32(1):192. PubMed ID: 23297286
[No Abstract] [Full Text] [Related]
[Next] [New Search]
