Experimental Procedures and Items, Investigational Devices and Clinical Trials

Transcript

1 Coverage Summary Experimental Procedures and Items, Investigational Devices and Clinical Trials 11/06/2007 E - 003 Products: UnitedHealthcare Medicare Advantage Plans Original Approval Date: Policy Number: /2018 08/21 Last Review Date: terpretation Committee Medicare Benefit In UnitedHealthcare Approved by: Related Medicare Advantage Policy Guideline s : Percutaneous Left Atrial Appendage Closure (LAAC)   0.1) Routine Costs in Clinical Trials (NCD 31 (NCD 20.34) This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use, and distribution are prohibited. This information is intended to serve only as a general reference reso urce and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on this information in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment Each benefit plan contains its own specific provisions for coverage, limitations, and exclusions in determining care. as stated in the Member’s Evidence of Coverage (EOC)/Summary of Benefits (SB). If there is a discrepancy between this r’s EOC/SB, the member’s EOC/SB provision will govern. policy and the membe The information contained in this document is believed to be current as of the date noted. The benefit information in this Coverage Summary is based on existing national coverage policy, however, Loca l Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. There are instances where this document may direct readers to a UnitedHealthcare Commercial Medical Policy, Medical Benefit Drug Policy, and/or Cov erage Determination Guideline (CDG). In the absence of a Medicare National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare coverage guidance, CMS allows a Medicare - determinations, using objective evidence Advantage Organization (MAO) to create its own coverage based rationale relying on authoritative evidence ( Medicare IOM Pub. No. 100 - 16, Ch. 4, §90.5 ). INDEX TO COVERAGE SUMMARY I. COVERAGE 1. Experimental and Investigational Procedures Investigational Device Exemption (IDE) 2. gory A Device Cate a. b. Category B Device Clinical Trials (also known as Clinical Research Study) 3. a. Routine Costs Associated with Medicare Approved Clini cal Trial b. Coverage with Evidence Development (CED) c. Complications Arising from Participating in All Qualifying Clinical Trials d. Cost Sharing for Clin ical Trials . e Evaluation for Clinical Trial II. DEFINITIONS REFERENCES III. REVISION HISTORY IV. Page 1 of 8 UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials United HealthCare Services, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8

2 I COVERAGE . rage Statement : Experimental and investigational procedures, items and medications are not Cove covered. Investigational Device Exemption (IDE) studies are only covered when the Medicare coverage requirements are met. roved Clinical Trials is Routine costs associated with Medicare app Medicare’s financial responsibility. Guidelines/Notes : 1. items , investigational procedures and not covered. are and medications Experimental Coverage Summary for M edications/Drugs For coverage of drugs and biologicals, refer to the (Outpatient/Part B) y, and Associated Drugs and and C overage Summary for C hemotherap . Treatments 2. Exemption (IDE) Investigational Device a. Device Category A Category A (Experimental) device refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. is responsible for payment of routine care ge Organization Medicare Advanta The MAO that are covered by the MAC items and services in CMS - approved Category A IDE studies CMS will not approve Category A with jurisdiction over the MA plan’s service area. devices because they are sta tutorily excluded from coverage. Medicare Managed Care Manual, Chapter 4, §10.7.2 See the – Payment for sed ) August 15, 2018 Investigational Device Exemption (IDE) Studies . (Acces Also see the Food and Drug - Medicare Benefit Policy Manual, Chapter 14, §20 . - Approved Investigational Device Exempti on (IDE) Studies Administration (FDA) Accessed ( August 15, 2018) Note: The local MAC(s) with jurisdiction over the MA plan’s service area determines coverage of IDE studies. CMS finalized changes to the IDE regulations (42 CFR § 405 listing of all CMS approved Category A IDE - Subpart B), effective January 1, 2015. A studies and Category B IDE studies will be posted on the CMS Coverage webpage site - and Studies.html - IDE IDE/Approved http://www.cms.gov/Medicare/Coverage/ located at August 15, 2018) (Accessed published in the Federal Register. b. Category B Device refers to a device for which the Category B (Nonexperimental/investigational) device on (that is, initial questions of safety and incremental risk is the primary risk in questi effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA r that device type. premarket approval or clearance fo MAOs are responsible for payment of claims related to enrollees’ participation in Category B IDE studies that are covered by the MAC with jurisdiction over the MA plan’s service tems and services in CMS - area. The MAO is responsible for payment of routine care i . approved - approved Category B IDE studies The MAO is also responsible for CMS Category B devices. 2 of 8 Page UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

3 Payment for – l, Chapter 4, §10.7.2 Medicare Managed Care Manua See the Investigational Device Exemption (IDE) Studies . (Accessed August 15, 2018) Food and Drug Also see the - hapter 14, §20 Medicare Benefit Policy Manual, C - Administration (FDA) Approved Investigational Device Exemption (IDE) Studies . ) 15, 2018 August Accessed ( Note: The local MAC(s) with jurisdiction over the MA plan’s service area determines coverage of IDE studies. zed changes to the IDE regulations (42 CFR § 405 CMS finali e ffective January 1, 2015 , a listing of all CMS - approved Category A IDE Subpart B), studies and Category B IDE studies will be posted on the CMS Coverage webpage site and located at http://www.cms.gov/Medicare/Coverage/IDE/Approved - IDE - Studies.html published in the Federal Register. August 15, 2018) (Accessed 3. (also known as Clinical Research Study) Clinical Trials a. R outine Costs Associated with Medicare Approved Clinical Trial Medicare has outlined the following payment rules for qualified clinical trials: - service rules, Medicare Administrative -  In accordance with applicable Medicare fee for directly pay providers for clinical trial services furnished to a will s (MAC) Contractor UnitedHealthcare Medicare member.  Medicare MACs make payments on behalf of MA organizations directly to providers of - for - service basis. See the covered clinical trial services, on a fee Medicare Managed Special Rules for the September 2000 NCD on Care Manual, Chapter 8, §40.4.3 - Also see – the Clinical Trials . Medicare Managed Care Manual Chapter 4, §10.7.1 (Accessed Payment for Services . August 15, 2018) If UnitedHealthcare Medicare receives a bill with clinical trial codes, these bills will  be paid but will be returned to the provider. UnitedHealthcare Medicare will not . MAC inform the provider that the bill should be sent to the appropriate The member is not responsible for meeting either Part A or Part B deductibles for  routine services obtain ed through qualified clinical trials. The member is liable for the coinsurance amounts applicable to services paid under  service rules when participating in a qualified clinical trial. - for Medicare fee - Notes: o CMS will make payments for MA enrollees on a fee - for - service basis for covered clinical trial costs under the September 2000 NCD. This policy is in effect until . In CY 2000, CMS determined that the cost of covering these new further notice rates, and since this cost benefits was not included in the 2001 MA capitated payment , Medicare paid for met the threshold for "significant cost" un der 42 CFR 422.109(a) covered clinical trial services outside of the capitated payment rate. CMS continues the policy of making payments on a fee - for - service basis for covered clinical trial urther notification, because the items and services provided MA enrollees until f capitation rates have not been appropriately adjusted to account for costs of this NCD, as required under §1853(c)(7) of the Social Security Act (the Act). clinical trial - Member should be directed to call - o 800 MEDICARE to determine if a 1 is approved by Medicare and for additional information on Clinical Trials. No prior . authorization by UnitedHealthcare MA Plan is required NCD for Routine Costs For Medicare coverage information on Clinical Trials, refer to the Page 3 of 8 UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

4 (Accessed August 15, 2018) . in Clinical Trials (310.1) Also see the Medicare Clinical Trial Policies at http://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/index.html?redirect=/Clini . calTrialPolicies/ August 15, 2018) (Accessed To access the list of CMS approved clinical trials/clini , go to cal research studies Select the applicable . Medicare Approved Facilities/Trials/Registries Facility/Trial/Registry from the list on the l eft column to view the approved clinical trials/clinical research studies. (Accessed August 15, 2018) b. Coverage with Evidence Development (CED) In National Coverage Determinations (NCDs) requiring CED, Medicare covers items and - services in CMS app roved CED studies. MAOs are responsible for payment of items and approved CED studies unless CMS determines that the significant cost - services in CMS ). Approved CED threshold is exceeded for that item or service 42 CFR 422.109 (see studies are posted on the CMS Coverage with Evidence Development webpage at http://www.cms.gov/Medicare/Coverage/Coverage Evidence - with - - . Development/index.html Billing instructions are issued for each NCD. Medica See the re Managed Care Manual, Chapter 4, §10.7.3 – Payment for Clinical . (Accessed August Studies Approved Under Coverage with Evidence Development (CED) 15, 2018) c. Complications Arising from Participating in All Qualifying Clinical Trials ers the routine costs of qualifying clinical trials for all Medicare enrollees, Medicare cov including those enrolled in MA plans, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participating in all ng clinical trials The Clinical Trial National Coverage Determination (NCD) qualifyi . defines what routine costs means and also clarifies when items and services are reasonable and necessary. All other Medicare rules apply Medicare Managed Care . Refer to the Manual, Chapter 4, §10.7 Clinical Trials August 15, 2018) (Accessed . d. Cost Sharing for Clinical Trials Medicare Advantage (MA) plans pay the enrollee the difference between Original e cost Medicar sharing incurred for qualified clinical trial items and services and the MA - - plan’s in - network cost - sharing for the same category of items and services. This cost ns sharing reduction requirement applies to all qualifying clinical trials. MA Organizatio (MAO) cannot choose the clinical trials or clinical trial items and services to which this policy applies. The MAO owes this difference even if the member has not yet paid the network cost clinical trial provider. Additionally, the member's in - - sharing p ortion must Medicare See the - pocket maximum calculation. also be included in the plan’s out - of - Managed Care Manual, Chapter 4, §10.7.1 . nt for Services Payme - Clinical Trials August 15, 2018 (Accessed ) To be eligible for reimbursement, beneficiaries (or providers acting on their behalf) must notify their plan that they have received qualified clinical trial services and provide sharin - g incurred, such as a Medicare Summary Notice (MSN). documentation of the cost - sharing information MAOs are also permitted to seek MA member Original Medicare cost directly from clinical trial providers. Refer to the member’s Evidence of Coverage (EOC) 4 of 8 Page UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

5 for additional information. e. Evaluation for Clinical Trial Plan or its delegate(s) will cover for one Medicare Advantage  The UnitedHealthcare - of - - (1) specialist referral for evaluation (in network or out network) of possible ne if a member is a candidate for a treatment of member, including a referral to determi Coverage Summary for Second ee the S Medicare approved clinical trial or set of trials. Third Opinions. and will not cover the Medicare Advantage Plan UnitedHealthcare The  or its delegate(s) qualify for the cost of services and tests solely for the purpose for the member to as they would not be considered routine costs under the clinical trial definition of the NCD. Once a member signs a Medicare approved clinical trial consent form, Original  Medicare is responsible for all subsequent routine clinical trial costs. DEFINITIONS II. plement, machine, contrivance, Medical Device (FDA Definition): An instrument, apparatus, im implant, in vitro reagent, or other similar or related article, including any component or part of - accessory that is: 1) recognized in the official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them; inten 2) ded for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals; intended to affect the structure or any function of the body of man or other animals, and which 3) does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Coverage of Medical Devices Medicare Benefit Policy Manual, Chapter 14, §10 – . (Accessed July 26, 2018 ) tems and services that are otherwise generally available to I Routine Care Items and Service: dicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is no Me national noncoverage decision) that are furnished during a clinical study and that would be Medicare Benefit . otherwise furnished even if the beneficiary were not enrol led in a clinical study July 26, 2018) . (Accessed Coverage of Medical Devices – Policy Manual, Chapter 14, §10 REFERENCES III. See above REVISION HISTORY IV. Updated policy introduction; added language to clarify: 04/01/2019  There are instances where [the Coverage Summary] may direct readers to a UnitedHealthcare Commercial Medical Policy, Medical Benefit Drug Policy, and/or Coverage Determination Guideline (CDG)  In the absence of a Medicare National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare coverage guidance, CMS allows a Medicare Advantage Organization (MAO) to create its own coverage 5 of 8 Page UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

6 nations, using objective evidence - based rationale relying on authoritative determi Medicare IOM Pub. No. 100 - 16, Ch. 4, §90.5 ) evidence ( 08/21/2018 Annual review with the following updates: ing language Guideline 2.b Category B Device – in the Note section; adding the follow “ CMS finalized changes to the IDE regulations (42 CFR § 405 Subpart B),” for MBPM. consistency with the referenced – 3.d Cost Sharing for Clinical Trials Guideline ” to Clinical Trials for Adding “ enced guideline title; for consistency with the refer MBPM. 0 review with the following updates: - Re /19/2018 6 Guideline 3.a (Routine Costs Associated with Medicare Approved Clinical Trial)  Deleted references to “carriers and intermediaries”; replaced with “Medicare Administrative Contractors (MAC)” Mo ved the following language from the Note Section to the Guideline Section and  added – reference link to the Medicare Managed Care Manual Chapter 4, §10.7 Clinical Trials. Medicare MACs make payments on behalf of MA organizations directly to vered clinical trial services, on a fee - service basis. See the for - providers of co - Medicare Managed Care Manual, Chapter 8, §40.4.3 Special Rules for the September 2000 NCD on Clinical Trials . – 08/15/2017 Guideline 2.a (Category A Device) Updated language to reflec  t the Medicare Managed Care Manual, Chapter 4, – §10.7.2 Payment for Investigational Device Exemption (IDE) Studies. Definitions d Experimental Procedures and Items  - eleted from Coverage Summary; unable to find same language in any CMS reference. 08/16/2 Annual review with the following updates: 016 – Guideline 2.a (Category A Device) Medicare covers routine care items and  Deleted the following verbiage “ study if CMS (or its services furnished in an FDA - approved Category A IDE designated entity) determine s that the Medicare coverage IDE study criteria are met. Category A devices are statutorily not covered by Medicare .” the Medicare Managed Care Updated with the following verbiage from Manual, Chapter 4, Section 10.7.2 “ The MAO Medicare Advantage ion is responsible for payment of routine care items and services in Organizat - IDE studies CMS that are covered by the MAC with approved Category ” jurisdiction over the MA plan’s service area. ed Add  CMS finalized changes to the IDE “ the following to the Note: tions (42 CFR § 405 Subpart B),” regula d the following verbiage “ Medicare may make Delete - Guideline 2.b (Category B) payment for a Category B IDE device and routine care items and services furnished - in an FDA approved Category B IDE study if CMS (or its design ated entity) determines prior to the submission of the first related claim that the Medicare Page 6 of 8 UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

7 coverage IDE are met. The MAO is responsible for payment of routine care items and services in CMS - approved Category B IDE studies, as well as the Category B devic e from Updated with the following verbiage under study in Category B IDE studies. ” the Medicare Managed Care Manual, Chapter 4, Section 10.7.2 “ MAOs are responsible for payment of claims related to enrollees’ participation in Category B e covered by the MAC with jurisdiction over the MA plan’s service IDE studies that ar area. The MAO is responsible for payment of routine care items and services in CMS - The MAO is also responsible for CMS - approved approved Category B IDE studies . ” Category B devices. Annual review without any updates. 2015 09/15/ Coverage Statement 04/21/2015 gory B Devices”, replaced Updated the coverage statement, deleted “FDA Cate  with “Investigational Device Exemption (IDE) studies. Guideline 2.a (Category A Device)  Updated coverage guid eline based on the updated Medicare Managed Care evice Exemption 10.7.2 Payment for Investigational D Chapter 4, Section Manual, - (IDE) Studies) Medicare Benefit Policy Manual, Chapter 14, Section 20 and ational Device Food and Drug Administration (FDA) Approved Investig Exemption (IDE) Studies. Guideline 2.b (Category B Device)  Updated coverage guideline based on the updated Medicare Managed Care 10.7.2 Payment for Investigational D Chapter 4, Section Manual, evice Exemption - 20 it Policy Manual, Chapter 14, Section Medicare Benef (IDE) Studies) and Food and Drug Administration (FDA) - Approved Investigational Device Exemption (IDE) Studies. Guideline 3.b (Coverage with Evidence Development) guideline based on the updated Medicare Managed Car  Updated coverage e Manual, Chapter 4, Section 10.7.3 – Payment for Clinical Studies Approved Under Coverage with Evidence Development (CED). Definitions DA to changed the reference link from F  Medical Device (FDA Definition) - ction 10 Coverage of Medical – Medicare Benefit Policy Manual, Chapter 14, Se Devices moved to Guideline 2.a - Category A Devices (Experimental/Investigational) FDA  (Category A Device) - Experimental/and/or Investigational) - FDA Category B Devices (Non moved to  Guideline 2.b (Category B Device) added definition .  - Routine C are Items and Service 09/16/2014 Annual review with the following updates: (Evaluation for Clinical Trial) Guideline #3.e evised the guidelines to indicate: r - will not c over or its delegate(s) Medicare Advantage Plan UnitedHealthcare The the cost of services and tests solely for the purpose for the member to qualify for the clinical trial as they would not be considered routine costs under the definition of the NCD. 7 of 8 Page UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

8 Definitions DA definition. : Updated the definition of Medical Device based on the F Guideline #2.a (Category A Devices) by Medicare unless they – added as not covered 04/15/2014 are part of a qualifying clinical trial. – updated the definition of FDA Category A based on the Medicare Definitions B Devices based Benefit Policy Manual; als o updated the definition of FDA Category on the Federal Register Final Rule dated December 10, 2013. 10/24/2013 Annual review with the following updates: FDA Guideline #2 (Investigational Devices)  added reference links for accessing – roved Category B devices. app - Guideline #3 (Clinical Trials)  CMS approved clinical added reference links to the website. trials/clinical research studies Added clarification that Medicare Advantage (MA) plans pay the Annual review; 04/29/2013 e difference between Original Medicare cost enrollee th sharing incurred for qualified - clinical trial items and services and the MA plan’s in - network cost sharing for the - same category of items and services. lude clarification that Clinical Trials are Guidelines #3 (Clinical Trials) updated to inc 10/31/2012 also known as Clinical Research Study; also added a note to further clarify Coverage with Evidence Development (CED). fy the Annual review; Guidelines #3 (Clinical Trials) updated to include a note to clari 02/27/2012 UHC MA Plan benefit coverage for the evaluation for clinical trial. 06/14/2011 Guidelines #3 Clinical Trials updated to include the updated Medicare coverage language on clinical trials based on the Medicare Managed Care Manual Chapter 4, 11). - 20 - Clinical Trials (effective 05 §10.13 02/21/2011 Annual review; Guidelines #2.d updated to include additional coverage information - pertaining to FDA approved IDE Category B devices. 08/26/2010 Care Manual updated. Reference and links to the NCD and the Medicare Managed 8 of 8 Page UHC MA Coverage Summary: Experimental Procedures and Items, Investigational Devices and Clinical Trials rvices, Inc. Proprietary Information of UnitedHealthcare. Copyright 201 8 United HealthCare Se

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