HCCA Research Compliance Conference. June 5-8, 2016

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1 There can be no doubt but that the statutes and provisions in question, involving the financing of Medicare, are among the most completely impenetrable texts within human experience... one approaches [them] with dread, for not only are they dense reading of the most tortuous kind, but Congress also revisits the area frequently, generously cutting and pruning in the process and making any solid grasp of the matters addressed merely a passing phase. EXCERPTED FROM REHABILITATION ASSOCIATION OF VIRGINIA, INC. V. KOZLOWSKI, ET AL., 42 F. 3D 1444,1450 (4 TH CIR. 1994) 2 1

2 MEDICARE PAYS FOR ITEMS AND SERVICE THAT ARE REASONABLE AND NECESSARY UNDER SOCIAL SECURITY ACT 1862(A)(1) WHICH STATES: Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services (A) which, except for items and services described in a succeeding subparagraph or additional preventive services (as described in section 1395x(ddd)(1) of this title), are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, 3 SECTION E OF THIS ACT ALSO ALLOWS MEDICARE TO PAY FOR ITEMS AND SERVICES IN RESEARCH *** (E) in the case of research conducted pursuant to section 1142, which is not reasonable and necessary to carry out the purposes of that section, *** 4 2

3 3 WAYS CMS COVERS CLINICAL RESEARCH 1. Coverage with Evidence Development Individual NCD policy 2. Clinical Trial Policy Routine costs in clinical trials NCD Manual, Pub 100-3, Section IDEs Regulation at 42 CFR Centralized process since #1. NATIONAL COVERAGE DETERMINATIONS (NCDS) REQUIRING COVERAGE WITH EVIDENCE DEVELOPMENT CED is. a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. In making coverage decisions involving CED, CMS decides after a formal review of the medical literature to cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary. CMS Guidance Document on Coverage with Evidence Development, November 20,

4 Coverage with Evidence Development In CED an item or service is only reasonable and necessary when it is provided within a research setting where there are added safety, patient protections, monitoring, and clinical expertise. Without CED, the service would not be covered. CED research may include a broader range of studies than randomized clinical trials may include observational research and registries. An NCD requiring CED may be specific about the design, research questions, and outcomes required. 7 HEALTH OUTCOMES OF INTEREST IN CED STUDIES Longer life and improved function/participation Longer life with arrested decline Significant symptom improvement allowing better function/participation Reduced need for burdensome tests and treatments Generation of evidence Forward-thinking Early access to innovative products Reduces costs 8 4

5 COVERAGE WITH EVIDENCE DEVELOPMENT (CED) Policy tool that allows health insurers to offer temporary payment for these promising- treatments while patients are enrolled in clinical study designed to provide key information about the safety and/or effectiveness of the treatment. CED is a form of accelerated approval applied in the reimbursement context, allowing promising technologies to secure reimbursement while important uncertainties are addressed through further studies. If the CED study shows that the new treatment is better than existing options, the insurer may expand coverage to more beneficiaries or decide to cover the treatment permanently. Conversely, the insurer may restrict coverage for treatments that do not lead to better patient outcomes. The main purpose of CED is to help doctors and patients make better choices about treatment. 9 COVERAGE WITH EVIDENCE DEVELOPMENT (CED) TRIALS Allogeneic Hematopoietic Stem Cell Transplant for MDS Amyloid PET Artificial Hearts Autologous Platelet-rich Plasma Cochlear Implantation CPAP For Obstructive Sleep Apnea Extracorporeal Photopheresis for Bronchiolitis Obliterans Syndrome Following Lung Transplant FDG PET and Other Neuroimaging Devices for Dementia Home Oxygen for COPD Home Oxygen for Cluster Headache Magnetic Resonance Angiography and Magnetic Resonance Imaging NaF-18 PET for Bone Metastasis Off-label use of Colorectal Cancer Drugs Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis Pharmacogenomic Testing for Warfarin Response TENS for chronic low back pain Transcatheter Aortic Valve Replacement Transcatheter Mitral Valve Repair 10 5

6 Medicare National Coverage Process resulting in Coverage with Evidence Development (CED) 6-9 months NCD opens CMS Staff Reviews Medical Literature Proposed Decision Memorandum Posted Public Comment Final Decision = CED CMS Staff Reviews Protocol CMS posts Approved Study on CED Webpage* CMS Staff Approves Protocol Sponsor submits Protocol * 11 Medicare National Coverage Process resulting in Coverage with Evidence Development (CED) 9 months NCD REopens CMS Staff Reviews Medical Literature Proposed Decision Memorandum Posted Public Comment Final Decision Study produces new evidence Sponsor conducts study 12 6

7 QUESTION ON CED STUDIES Are codes, modifiers and NCT# required on these studies? Why are the codes the same as for research such as in the TAVR registries? What if the physician does not tell you that they are participating in a CED study or registry? MAPs are sometimes requiring pre authorization which not allowed under the CMS Managed Care Manuals. Is this okay with CMS? MAPs have to cover CED trials and they do not know this so they see the codes and they deny the claim. 13 #2 THE CLINICAL TRIAL POLICY* (CTP) The CTP is under NCD # The CTP allows coverage of the routine costs of qualifying clinical trials and reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply. * AA%3d%3d& 14 7

8 THE CLINICAL TRIAL POLICY* (CTP) The CTP covers Routine Costs of a clinical trial including all items and services that are otherwise generally available to Medicare beneficiaries that are provided in either the experimental or the control arms of a clinical trial except: The investigational item or service itself unless otherwise covered outside of the clinical trial; Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; and Items and services provided free of charge for any enrollee in the trial. 15 THE CLINICAL TRIAL POLICY (CTP) Routine costs in clinical trials include: Items or services that are typically provided absent a clinical trial Items or services required solely for the provision of the investigational item or service, appropriate monitoring of the effects of the item or service, or prevention of complications; and Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications. 16 8

9 QUALIFYING FOR THE CTP A trial also must: Test whether the intervention potentially improves the participants' health outcomes; Be well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use; Not unjustifiably duplicate existing studies; Be appropriate to answer the research question being asked in the trial; 17 QUALIFYING FOR THE CTP A trial also must: Be sponsored by a credible organization or individual capable of executing the proposed trial successfully; Be in compliance with Federal regulations relating to the protection of human subjects; and Be conducted according to the appropriate standards of scientific integrity. 18 9

10 QUALIFYING FOR THE CTP A trial is deemed to be qualified it is one of the four below: It is funded by NIH, CDC, AHRQ, CMS, DOD, and the VA; It is supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA; Is conducted under an investigational new drug application (IND) reviewed by the FDA; and Is a drug trial that is exempt from having an IND under 21 CFR 312.2(b)(1) BUT THE TRIAL ALSO MUST MEET THE THREE ON THE NEXT SLIDE! 19 QUALIFYING FOR THE CTP A trial must have the following qualities: The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category The trial must have therapeutic intent. The trial must enroll patients with a diagnosed disease rather than healthy volunteers

11 QUESTIONS ON THE CTP There is a misconception in the oncology community that all NCTN studies are automatically qualifying and therefore do not need to have codes and modifiers or an NCT# or not go through a rigorous process. Do you believe that studies must be deemed and qualifying to meet the routine cost criteria outlined in the CTP? What about studies that do not have an investigational drug such as radiation therapy studies Most sites treat these as not a drug, device or a CED, therefore no codes, modifiers or NCT# is required. Do you agree? Studies that have more than one arm as comparators but all arms are conventional care. Are modifiers, codes and the NCT# required? 21 QUESTIONS ON THE CTP Medicare Advantage Plans do not cover the items and services for drug clinical trial services so the sites have an extremely manual process for ensuring that the subject does not end up with an outstanding bill for a trial. Is there any movement toward Medicare ensuring that the contracts with Medicare Advantage Plans cover the routine costs in a drug trial as this is hampering accrual across the country? Long term follow up is impractical for placing codes, modifiers and the NCT# on the claim many patients return to a different practitioner for long term care. Is there a possibility of stating that once a patient is off drug the codes, modifiers and NCT# is no longer required? This would make it much easier and Medicare Advantage could then be sent claims for the conventional care that occurs long term after participation in a drug trial

12 QUESTIONS ON THE CTP There remain differing opinions on therapeutic intent. The Affordable Care Act includes phase I studies, and this creates inconsistencies for handling treatment claims for subjects. Can Medicare produce a Q&A that outlines phase I better so there is not so much variance? Q1 s sometimes end up on items that are not part of the study calendar. Is this a real issue for Medicare as long as the subject is consented and participating? How do you feel about screening tests being paid by a sponsor for a subject when they fall outside of a window for participation and the test must be repeated and all other subjects fell within window and it was conventional care? Can a sponsor cover that for a particular subject who needs a repeat test for screening that is not a covered benefit? 23 #3 INVESTIGATIONAL DEVICE EXEMPTION (IDE) STUDIES FDA reviews and approves/disapproves an IDE trial/study. The FDA categorizes IDE s as A (experimental) or B (investigational) CMS may consider a trial/study for coverage CMS reviews study documentation and approves/disapproves a trial/study for coverage. Category A CMS may cover routine services in the trial Category B CMS may cover both routine services and the Category B device in the trial 24 12

13 INVESTIGATIONAL DEVICE EXEMPTION (IDE) STUDIES Old process Study sites submit IDE documentation to regional MACs for review and approval Continue as instructed by the MAC for trials with FDA approval letter dated before January 1, New process Sponsors with an FDA approval letter dated after January 1, 2015 submit the following: Study title Sponsor name NCT number IDE number CMS approval date 25 INVESTIGATIONAL DEVICE EXEMPTION (IDE) STUDIES FAQ S Now that there is a new system, will CMS central issue the annual approvals to IDE study sites? If the FDA approval letter is dated before January 1, 2015, then MACs continue to issue annual approvals. If a provider intends to become an IDE study site, should the provider submit a full request to CMS central? It is the study sponsor, or the individual named in the FDA letter, who submits the IDE coverage request to CMS. MACs may have additional requirements and should continue to interact with the study sites in their region. If the IDE letter is dated before January 1, 2015, then the request should be submitted to the MACs. The following MACs still have requirements: CGS J-15;FCSO J-N; Noridian J-E & J-F; Palmetto J-11 How will a study site know if CMS has approved an IDE study? CMS will post each approved study on its website with the category status or A or B 26 13

14 Approved IDE Studies Listed Here 27 QUESTION ON DEVICE STUDIES Medicare Advantage Plans repeatedly will instruct a site to bill regular Medicare fee for service for the implantation of a device study when it is clearly no consistent with the device claims processing. What is Medicare s feeling on doing what a Medicare Advantage plan directs a site to do in writing? 28 14

15 Coding for Clinical Trials NCD for Platelet Rich Plasma

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18 35 Approved CED Studies for PRP NCD (excerpt) Study Title: Effectiveness of Autologous Platelet Rich Plasma in the Treatment of Chronic Non- Healing Wounds Sponsor: ACR Biologics, LLC ClinicalTrials.gov Number: NCT CMS Approval Date: 10/31/2014 Study Title: A Prospective, Randomized Clinical Trial of ECLIPSE PRP Wound Biomatrix in Non- Healing Diabetic Foot Ulcers Sponsor: PRP Concepts, LLC ClinicalTrials.gov Number: NCT CMS Approval Date: 09/25/2014 Study Title: Leucopatch System in the Management of Hard-To-Heal Diabetic Foot Ulcers Sponsor: Nottingham University Hospitals NHS Trust (Reapplix Aps) ClinicalTrials.gov Number: NCT CMS Approval Date: 08/14/2014 Study Title: A Multi-Center, Randomized Trial Comparing the Effectiveness of APIC-PRP to Control, when added to Standard of Care in the Treatment of Non-healing Diabetic Foot Ulcers Sponsor: Cytonics Corporation ClinicalTrials.gov Number: NCT CMS Approval Date: 07/30/

19 CODING AND OTHER BILLING ISSUES Autologous Platelet Rich Plasma is only covered by Medicare under the CED, other payers won t cover it. Challenges with non-chemo drugs used off label like the metformin which is in some NCI studies (not billable).. Coding for routine care within a trial that is such as surgery that would clearly be conventional care but it is part of the study (think neo and adjuvant chemo) and how is that coded. Condition Code 30?

20 Thank you 39 20