Medicare Coverage with Evidence Development Pt. 1: ICDs

Coverage with Evidence Development (CED)

Guidance for the Public, Industry, and CMS Staff / National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development. Centers for Medicare and Medicaid Services. 2006.07-12. Available from https://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8

Experience should teach us to be most on our guard to protect liberty when the Government's purposes are beneficent. Men born to freedom are naturally alert to repel invasion of their liberty by evil–minded rulers. The greatest dangers to liberty lurk in insidious encroachment by men of zeal, well–meaning but without understanding.

Olmstead v. United States, 277 U.S. 438, 479, 48 S. Ct. 564, 572-73, 72 L. Ed. 944, 957 (1928)

Medicare recently introduced a new policy in which beneficiaries seeking reimbursement for certain medical devices and drugs, especially expensive new ones, will be required to enroll in research as a condition of Medicare coverage. To the extent that threats to withold reimbursement for medical care constitute coercion, this policy violates the fundamental ethical principle that people must give voluntary informed consent before enrolling in research. This principle is codified in federal regulations governing federally funded research and products subject to FDA regulation in research with human subjects.

This new policy conflicts with recent rule-making (announced in 2000) in which Medicare announced it would reimburse beneficiaries enrolled in research only if the study was conducted according to federal regulations for the protection of human subjects.

Because Medicare is responsible for paying for items and services that meet the necessary and reasonable standard, the agency has a material interest in the outcome of research bearing on this issue. When Medicare initiates or oversees such research, the agency is subject to a conflict of interest that requires extremely careful management, and then only after experts have concluded that Medicare has any business in research like this in the first place. At minimum, this new policy requires clarification, and must ensure the protection of the rights and welfare of research subjects. In the interim, beneficiaries should consult with their licensed primary care physician to determine if enrollment in a clinical trial is in their best medical interest. More information can be found below, and CIRCARE will update this page as additional information becomes available.

We encourage everyone to read draft guidances and submit comments to Medicare. We intend to post our comments to CMS to help readers understand what's at issue in the policy.

Draft Guidance: Factors CMS Considers in Making a Determination of Coverage with Evidence Development (issued 2005-04-07)
Comments due: 2005-06-06

For questions regarding the Coverage with Evidence Development initiative, please contact Rosemarie Hakim, PhD, at (410) 786-3934.

Public Comment: Electronic comments may be submitted to CAGInquiries@cms.hhs.gov. Alternatively, written comments may be submitted to the Coverage and Analysis Group, Centers for Medicare and Medicaid Services, mailstop: C1-12-28, 7500 Security Blvd. Baltimore, Md. 21244. Please refer to this guidance document when submitting comments. In order to ensure consideration, comments must be received by June 6, 2005.

Public Comments on Guidance Document on Coverage with Evidence Development (CED) (2005-04-07 through 2005-06-07)

Fact Sheet: CMS Responds to Stakeholder Concerns about Coverage with Evidence Development (2005-04-07 through 2005-06-07)

We offer comment here on several items in the purported Fact Sheet:

Q: What is CMS' authority to collect data on beneficiaries in return for payment?

A: CMS collects data under a number of authorities, including the authority to collect data for payment purposes. This authority stems from the Social Security Act (§1862(a)(1)(A)). CMS uses this authority to determine whether an item or service is reasonable and necessary, based on CMS' own medical judgment. In the case of CED decisions, CMS needs data to ensure that payment is made for patient claims that meet the criteria specified in each NCD. CMS will use the data collected to determine whether an item or service was used for the appropriate reasons for the appropriate patients.

Comment: CMS may have the authority to collect data for payment purposes but they don't have the authority to force beneficiaries to enroll in research without giving informed consent. The ICD Registry is research, plain and simple. It's unlikely that CMS will use the data collected to determine whether an item or service was used for the appropriate reasons for the appropriate patients because CMS commissioned the ICD registry study to determine if an ICD is reasonable and necessary for primary prevention.

Based on the results of the registry study at some future time, CMS might be able to begin to determine this. CMS will not be able to determine whether an ICD is reasonable and necessary by the act of having a beneficiary's data entered into the ICD Registry, as they assert here.

Q: If CED data are to be used for payment, how will evidence about a particular item or device continue to develop?

A: Although CMS will use the data to make payment determinations, the data will be available in a number of forms for analyses by CMS and the general public. As the results of those analyses are published in peer-reviewed literature, the CED data will contribute to the existing evidence base.

Comment: How indeed? CMS has conflated health care operations with poorly designed research.

Q: How will patient privacy be protected?

A: Providers are required to inform patients about HIPAA protections during every encounter. Providers have access to protected health information for the purposes of treatment, payment, and health care operations (under 45 CFR 164.501). After CMS acquires patient data, it is protected under the Privacy Act. A Systems of Records Notice (SOR) announces to the public that the data reside in CMS. The SOR specifies the authorized uses and conditions of use of the data.

Comment: Privacy is very nice but it pales in comparison to autonomy. Providers do indeed have access to protected health information for the purposes of treatment, payment, and health care operations, but this is research, not health care operations. Institutions with a Federal Wide Assurance (FWA) are obligated to protect the rights and welfare of research subjects according the Common Rule, specifically by ensuring all research is reviewed and approved by the IRB prior to enrolling subjects. Failure to comply with the Common Rule jepardizes the institution's FWA, and in turn, its eligibility to receive federal research funds. In addition, several states and state medical practice acts have laws requiring IRB review and approval of research, and conditions under which informed consent is to be obtained.

Q: What will CMS do with data collected under CED?

A: CMS will rely on the data to determine whether the expanded service is reasonable and necessary for each patient who is the recipient of the item or service. Once collected, CMS or the public may have access to the CED data for research.

Comment: This is obtuse: in the first section, CMS claimed the act of collecting this data was to determine if an ICD was reasonable and necessary. Here they assert that they will determine whether an ICD is reasonable and necessary after collecting the data. Logically both claims cannot be true.

In response to comments submitted on Medicare's Guidance Document on Coverage with Evidence Development (CED), we received this notice:

On behalf of the Coverage and Analysis Group, we would like to thank you for your interest in the first draft Coverage with Evidence Development (CED) guidance document. We are carefully considering all comments received and plan to issue a second draft of the guidance document by fall 2005. In the meantime, we have issued a fact sheet that addresses some of the concerns raised during the comment period. The CED Fact Sheet is available online at http://www.cms.hhs.gov/coverage/guidance.asp.

We look forward to receiving your comments on the second draft.

Sincerely,

Steve E. Phurrough, MD MPA
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services

What is this about? Coverage with Evidence Development would require beneficiaries to enroll in research as a condition of coverage in certain circumstances. Apparently the new policy is an attempt to cope with rising costs while speeding access to promising new technologies in situations when a National Coverage Determination (NCD) finds insufficient evidence for coverage. While this sounds very nice in prospect, and mindful of beneficiaries seeking access to newly approved drugs and devices and the costs of health care, compelling certain people to become research subjects as a condition of coverage is unethical and sets a troubling precedent.

Read the CIRCARE InfoMail: Federal Guideline Would Coerce Human Subjects into Clinical Trials Without Informed Consent (2005-05-25)

This initiative is under the direction of the newly created Council on Technology and Innovation, a small group designed to provide the Agency with improved methods for developing practical information about the clinical benefits of new medical technologies resulting in faster and more efficient coverage and payment of these medical technologies.

More information about the Council on Technology and Innovation (CTI) is available in this Medicare press release of 2004-08-14

The council ostensibly consists of senior level CMS leaders and experts on clinical, coverage and payment issues, in practice, however, two senior Medicare employees are routinely the only names in evidence: co-chairs Herb Kuhn, Director of the Center for Medicare Management, and Sean Tunis, MD, Director of the Office of Clinical Standards and Quality.

Dr. Tunis has been on administrative leave pending disposition of charges filed by the Maryland Board of Physicians for allegedly falsifying records related to Continuing Medical Education requirements and refusing to obey a subpoena issued by the board.

Medicare Official Is Placed on Leave
Ceci Connolly, The Washington Post, 2005-04-08
URL: http://www.washingtonpost.com/wp-dyn/articles/A37880-2005Apr8.html (requires free registration)

The council also appears to lack the patients or patient advocates represented on other CMS decision making bodies. While it's possible that a small committee might overcome delay and red tape often caused by bureaucracy, it's equally possible that the committee might loose the benefit of valuable advice.

Many of the troubling issues that follow are related to the report of HHS' Medical Innovation Task Force , titled Moving Medical Innovations Forward – New Initiatives from HHS (2005-01). In the near future we hope to tackle the report and the consequences of the task force's recommendations where they intersect with human research protections.
Many people may also be surprised that CMS believes a number of clinical trials sponsored by the agency are health services research, e.g., Quality Improvement activities exempt from human subject protection regulations: Active Project Reports 2004

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Implantable Cardiac Defibrillators (ICDs)

CMS has published final details on Implantable Cardiac Defibrillators for Primary Prevention:
URL: Summary of Coverage for ICDs (2005-01-27)

The final guidance on ICD for Primary Prevention suggests our concerns were well founded: item e quoted below requires Medicare patients to enroll in research as a condition of coverage of ICD for Primary Prevention. Most people would be enrolled in the ICD Registry. There are two problems with this, at least. It's unethical to enroll people in research unless they give voluntary informed consent, and failing to obtain informed consent violates federal regulations for the protection of research subjects, with which CMS and many, or most, researchers must comply. But more importantly, the ICD Registry is research with human subjects that's been misconstrued as Quality Improvement (QI). According to CMS guidance for ICDs, p.3 :

e. The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual §310.1) or a qualifying data collection system including approved clinical trials and registries. Initially, an implantable cardiac defibrillator (ICD) database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC) — a Quality Improvement Organization (QIO) contractor — for determination of reasonable and necessary and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to the IFMC who will collect and maintain the database. Additional stakeholder-developed data collection systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria:

• Written protocol on file;
• Institutional Review Board review and approval;
• Scientific review and approval by two or more qualified individuals who are not part of the research team;
• Certification that investigators have not been disqualified.

Federal regulation for the protection of human research subjects at 45 CFR 46 affords people enrolled in research vital protection by requiring IRB review and approval of proposed research to ensure the risks of participation are minimized and reasonable in comparison to potential benefit (if any); by requiring voluntary informed consent be obtained from the subjects before enrollment; and by reviewing the study at appropriate intervals. There's more involved, but even this suggests important differences from Quality Improvement (QI). Medicare QI is subject to HIPAA, which requires IRB review and approval of privacy practices to prevent unauthorized disclosure of protected health information.

In QI an IRB aims to keep your medical records safe: in research the IRB aims to keep you safe, and by requiring investigators to obtain voluntary informed consent prior to enrollment, it preserves autonomy, a funny sounding word that works out to the freedom to decide what happens to you.

CMS Summary of Coverage for ICDs, Appendix IV

ICD Registry Hypotheses (2004-12-23)

ICD Registry Data Elements (2004-12-23)

Related Information

Implantable Cardiac Defibrillator Abstraction Tool, from QualityNet Exchange (Accessed 2005-06-27)

ICD Implant Data Form (2005-02-01)

More information on the ICD registry.

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Updates

On 2005-07-07, Medicare received a National Coverage Decision (NCD) request from Cambridge Heart Inc. for Microvolt T-wave Alternans (MTWA) testing, a non-invasive diagnostic test that detects minute electrical variability in a portion of the electrocardiogram known as the T-wave. Chief among the reimbursible indications would be risk–stratification of patients receiving an ICD for primary prevention:

Medical literature suggests that, within patient groups that may be considered candidates for implantable cardioverter defibrillator (ICD) placement, a negative MTWA test may be useful in identifying low-risk patients who are unlikely to benefit from, and who may experience worse outcomes from, ICD placement.

If Cambridge Heart's device can meet the reasonable and necessary standard required for a positive NCD, Medicare would have a useful test to identify patients unlikely to benefit from ICD implantation.

On 2005-08-01, Bob Thompson, Director of Reimbursement, Economics and Health Policy at Medtronic, Inc. submitted public comment to Medicare's NCD consideration for MTWA. In the excerpt below, the Medtronic representative describes 2 clinical trials of MTWA, purportedly designed to demonstrate the negative predictive value of MTWA, which Medtronic believes to be consistent with CMS' interests:

Medtronic supports the CMS position on MTWA. In fact, we are pleased to sponsor the MASTER I trial of MTWA, a 656 patient, prospective trial with a 12 month follow-up period and the MASTER II trial of MTWA, a 405 patient, prospective trial with a 30 month follow-up. Consistent with CMS' interests, the objective of these trials is to demonstrate the negative predictive value of MTWA. Currently, the enrollment for both studies has been completed and the first manuscript is expected in September 2006.

We do not believe there is adequate evidence in the peer-reviewed medical literature, at this time, to conclude that MTWA improves net health outcomes and that MTWA is reasonable and necessary for the purposes described in the request for an NCD. In particular, while MTWA is a promising risk-stratification technology, there is insufficient evidence to support the requestor's statement on page three that MTWA can be successfully used to risk stratify patients with known left ventricular ejection fraction (LVEF) and identify those patients who should be referred on for ICD therapy as well as patients who are at low risk for SCD and therefore may be medically managed.

It is important that the results of the two Medtronic MASTER trials, as well as the two ongoing trials from other companies (ABCD and ALPHA), are known before a national coverage determination is made. As the requester has indicated, the technology is already available in more than 40 states, through local coverage, so patient access is not being denied. We view the local coverage decision making process to be the appropriate mechanism for Cambridge Heart to seek expanded coverage of MTWA until such time as there is adequate evidence to support an NCD.

On page seven of their letter, the requester suggests that MTWA could become a required data element in the CMS required ICD primary prevention registry. We believe it would be inappropriate to revise the ICD national coverage policy based on a request for a national coverage determination for MTWA. Revising the ICD national coverage policy, or any other national coverage policy, should be done only through a formal reconsideration of that policy, something that is neither necessary or appropriate for ICD national coverage at this time.

Thank you for the opportunity to comment.

Accessed 2005-08-03 at: http://www.cms.hhs.gov/mcd/publiccomment_popup.asp?comment_id=1775

Evaluation of the comment and consistency of interests are left to readers. Medtronic and other ICD manufacturers derive direct financial benefit from the recently revised NCD for ICDs because it expanded the conditions under which Medicare provides reimbursement. If MTWA testing can demonstrate positive predictive value, e.g., identify patients unlikely to benefit from an ICD, Medicare (might) refuse reimbursement for these patients, which inevitably impacts ICD sales, though to what extent is anybody's guess. The MASTER I and II trials being conducted by Medtronic raise several red flags:

• Study sponsor Medtronic will benefit directly if the trial demonstrates negative predictive value from MWTA testing in patients
• Study sponsor Medtronic is enrolling humans in research to demonstrate the negative predictive value of MTWA, or put differently, Medtronic is conducting research to demonstrate MTWA testing doesn't work
• If Medtronic's study is successful, Medtronic benefits

Conflict of interest is ubiquitous in research, and conflict of interest is not limited to the financial — this is not news to anyone, and what's more, IRBs can, and must, limit, mitigate, or remove situations where investigators are likelier to prefer one choice over another. Medtronic should not be judged on the basis of this limited information.

The larger problem may be less obvious: the studies appear to be designed to demonstrate that MTWA testing cannot predict who is unlikely to benefit from an ICD. It seems to have escaped Medtronic's notice that no study design can prove to a reasonable degree of certainty that MTWA testing does not identify patients unlikely to benefit from an ICD. A controlled trial testing cause and effect can either confirm or fail to confirm the study hypothesis: if data meet the pre-determined endpoint, the hypothesis is confirmed, while failure to meet the endpoint fails to confirm it. Failure to confirm that MTWA testing has the predictive ability to identify patients likely to do poorly with ICDs is fundamentally different from proving that MTWA testing cannot identify patients likely to do poorly with ICDs.

Implantable Cardiac Defibrillators (ICDs) Cont.

Just in case anyone was wondering how much of this is this about money, here are two market analyst reports on ICD research as it relates to investing in publicly traded device manufacturers Guidant, Medtronic, and St. Jude Medical. Investment banker and market analyst Deutsche Banc, like many of their competitors, solicits information about on-going research to predict financial opportunities. Analysts seek out men and women likely to have the best access to information: the investigators conducting the studies.

Deutsche Banc: AHA Takeaways from Our Physician Dinner. Update on MADIT II, Guidant's Contak CD study, and Medtronic's MIRACLE trial (2001-11-13)

Deutsche Banc: MADIT II Just What the Doctor Ordered. Guidant announces MADIT II suspended early due to overwhelming positive benefit from ICD implantation; key implication of MADIT II: 2–fold increase in number of patients eligible for ICDs in US alone (2001-11-21)
Deutsche Banc reports courtesy of Drug researchers leak secrets to Wall St., by Luke Timmerman and David Heath, Seattle Times, 2005-08-07. Accessed 2005-08-08 at: http://seattletimes.nwsource.com/html/businesstechnology/drugsecrets1.html?syndication=rss&source=businesstechnology.xml&items=19

A recent study suggested ICDs could benefit a much larger number of patients than previously believed if they were implanted for primary prevention. Expanding coverage for ICDs to include primary prevention would cost Medicare several billion dollars, yet the data suggest ICDs would never need to shock most recipients. To resolve this dilemma, patients who don't meet the criteria currently established by the NCD for ICDs, but might benefit from an ICD for prevention will be required to enroll in research as a condition of coverage. The design of the clinical trial would enroll subjects in a registry, a database set up to collect specific information which, after an appropriate period, would provide information to CMS to decide if ICDs for primary prevention are reasonable and necessary.

There are several rather enormous problems with this plan, chief among which are that this is unlikely to work, and arbitrarily directing beneficiaries to become research subjects rather than obtaining their informed consent is unethical.

Statements from the Open Door Forum (2005-02-14) Comments from: Dr. Stephen Hammill, MD, Pres., Heart Rhythm Society; Alex Clyde, VP, Health Policy & Payment, Medtronic Inc.; Carol A. Kelly, Executive VP, AdvaMed; Medical Device Manufactures Association (MDMA).

Why are there no comments from the people in whom the devices will be implanted?

The following quote from Steven Hammill, M.D. is troubling:

An unresolved issue with the collection of registry data is the question of IRB approval. Collecting the data for payment and quality purposes does not require IRB approval as it falls under healthcare operations in the HIPAA regulations. However, when the CMS data collected by the QNET system is merged with longitudinal data entered in the second phase of the registry then patient identifiers would most likely be required with some type of limited IRB approval or consent. It would be quite unfortunate to have the informed consent process become a major stumbling block to entering patients and thus preventing patients from receiving primary prevention ICD therapy and being followed in the registry

Why is institutional review board (IRB) approval, as required by federal regulations, an unresolved issue?

HIPAA does indeed require some type of IRB review but this misses the point. HIPAA requires IRB approval when it pertains to certain QI activities, and QI collects information about medical care. The purpose of enrolling subjects in the registry is to see if an ICD will be beneficial: this is research, not medical care. Since QI is limited to medical care, this registry cannot be QI, and meeting QI requirements under HIPAA becomes moot. The question is why this research should be confused with QI.

Why would obtaining voluntary informed consent from research subjects be a major stumbling block to entering patients in a registry?

How could the alleged stumbling block of obtaining informed consent prevent patients (properly called research subjects) from receiving primary prevention ICD therapy if the purpose of the registry is to see if an ICD works as primary prevention and whether primary prevention ICD therapy is beneficial to this group of subjects? It appears the speaker has put the cart before the horse and assumes primary prevention ICD therapy is beneficial, but logically it cannot be, given this is the question the research hopes to answer.

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By letter of 2004-11-24, opening with Dear Steve and Sean, the Heart Rhythm Society described their progress on the ICD registry. Recapping developments following the 2004-10-04 meeting with CMS, the majority working group was moving forward on several fronts, despite the fact that some members of the ICD registry working group still opposed the registry and wanted clarification of its purpose, especially in view of the data from clinical trials, and the limited prospects of adding to it from the proposed registry.

The ICD for Primary Prevention Registry up and running with directions for use at: MediLearn SE0517, Tool for Registering Patients with Implantable Cardiac Defibrillators.

Medicare Transmittal #497, Date: March 8, 2005 Implantable Automatic Defibrillators

Presumably the registry is enrolling subjects who've been told they had to become research subjects unless they could cough up the price of an ICD, or they could refuse and go contemplate their mortality. Perhaps nobody told them anything: the American College of Cardiology links to this CMS announcement and implies the registry is Quality Improvement: http://www.acc.org/advocacy/weekly/archives/feb_05/022805.htm#3

Information on the CMS ICD for Primary Prevention Registry is also available from the Heart Rhythm Society. The organization sells tape recordings of Steven Hammill, M.D's lecture explaining the ICD Registry: Understand CMS' Final Decision on Expanded ICD Coverage! (SCD-HeFT).  Is CME credit available for this?

Splendid.

More information on the ICD registry, including which patients must be enrolled in research on the basis of their conditions, is available from the Heart Rhythm Society at: http://www.hrsonline.org/swAdvocacyFiles/advocacy103469847.asp

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It's fair to ask if there is any real controversy over whether this is research or QI. The answer is no. CTI co-chair Sean Tunis, M.D. and Medicare chief Mark McLellan, M.D. make this explicit in a recent article published in The New England Journal of Medicine in which they discuss ICD coverage with evidence development and the clinical trial proposed to develop the evidence:

Medicare coverage of ICDs
McClellan MB, Tunis SR. N Engl J Med 2005;352:222-224
URL: http://content.nejm.org/cgi/content/full/352/19/2022 (requires free registration)

A registry database might look like Quality Improvement (QI), which also involves using information stored in databases, though in very different specific ways. In broadest terms, research is the collection of data on identifiable living human beings. With minor exceptions, research governed by federal regulations requires review and approval by an institutional review board and sets forth the criteria for obtaining requisite informed consent from subjects prior to enrollment. In contrast, for the most part, QI uses information collected about medical care in hospitals to improve the delivery of care. With the exception of IRB approval of measures to protect privacy in certain situations, QI is exempt from federal research protection regulations because it isn't research. The crucial word here is medical care. QI looks at data from medical care: research answers questions by testing an intervention to see if it's effective, or in some trial designs, which of two interventions is more effective for a specific indication. Medical care, or treatment, represents the physician's best recommendation for an individual patient in a given situation, while research assigns subjects to receive one or more interventions under controlled conditions to answer a question. A somewhat crude but useful way to think about the difference is that QI looks at what your doctor did, while research dictates what the physician-investigator does. The distinction is important, and it isn't always apparent. Fundamental ethical principles and federal regulations demand that subjects give informed consent prior to participating in research and require the proposed research be reviewed and approved by an IRB in order to minimize risk to the subject. It would be unfortunate if registry studies on subjects with ICDs were conducted without adequate oversight and protection because such research was misconstrued as QI.

The bottom line is that nine ICD trials have enrolled more than 6200 subjects, most of whom were under the age of 65. In the trials suggesting benefit of prevention, when ICDs fired, they probably saved a life; but ICDs shocked the hearts of less than 10% of subjects (absolute decrease in mortality, 7.2% over 5 years). The expanded coverage for prevention includes 500,000 potential Medicare recipients at a price of approximately $15 billion, and hence the coverage with evidence development. Before compelling beneficiaries to enroll in research to determine if ICDs for prevention meet the necesary and reasonable standard for coverage, trial data should be pooled to see if answers can be obtained. If the data is insufficient to answer the question, as is likely, it's unclear why it's Medicare's business to find the answer. The medical device industry is well aware of the value of Medicare coverage and this is a profitable industry. Because they stand to profit from coverage, it should be incumbent upon the the manufacturers to provide evidence meeting the necessary and reasonable standard. It's unclear why CMS should spend time and energy designing and promoting clinical research – something with which they have little experience – to compel beneficiaries to serve as research subjects for the profit of the medical device industry.

Evidence-based use of cardiac procedures and devices
Hlatky MA. N Engl J Med 2004;350:2126-2128
URL: http://content.nejm.org/cgi/content/full/350/21/2126 (requires free registration)

Letter to the Editor
Mack, MJ. N Engl J Med 2005;352: 2022
URL: http://content.nejm.org/cgi/content/full/352/19/2022 (free registration required)

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Coverage Decision Memorandum for Implantable Cardioverter Defibrillators (2004-12-28)

CMS summarized comments received the proposed ICD Registry, and physicians share our concerns:

Registry

Approximately 45 comments discussed the CMS requirement that patients receiving an ICD for primary prevention of sudden cardiac death be enrolled in a registry. Many commenters supported a registry with certain conditions while others did not support a registry in any way. Commenters that did not agree with a registry requirement stated that the evidence from clinical trials already demonstrate ICD benefit for primary prevention and further study through a registry is not necessary and would add no value. Others commented that a registry would not be possible at their institutions because institutional review boards would not approve participation, they would violate privacy and confidentiality requirements of the Health Insurance Portability and Accountability Act or the burden on their resources would be too great. Many commenters raised questions about details of the registry that were not outlined in the proposed decision memorandum such as hypotheses, data elements, funding, management, analysis and access.

Some commenters were concerned that requiring a registry would delay coverage and limit patient access. Their recommendations included allowing a grace period between the effective date of coverage and registry participation, decoupling registry participation from payment and requiring a sampling of ICD patients rather than the entire Medicare primary prevention population.

Registry supporters stated that an ICD registry could provide real-world outcomes, assist in answering questions that require a large sample size such as subgroups of women and patients over age 80 and may be hypothesis generating in regard to risk stratification. Commenters made various recommendations on implementing a registry. One commenter suggested that only one registry be used to facilitate tracking and auditing rather than allowing multiple registries to collect data. Other commenters suggested that a valuable registry could be implemented if it was done carefully, with good planning, cooperation from stakeholders and had credible oversight.

Issues in a Modernized Medicare Program, Medicare Payment Advisory Commission, Report to the Congress (2005-06)

In its most recent report to congress MedPAC briefly discussed several of the situations in which Medicare currently requires beneficiaries to enroll in research as a condition of coverage in chapter 8, Using clinical and cost effectiveness in Medicare. This discussion, which includes Coverage with Evidence Development, is peculiar indeed. On p. 181, they write that:

Recently, CMS is also linking national coverage with participation in comparative clinical trials and data registries in order to determine the effectiveness of new services for Medicare beneficiaries. The agency refers to these comparative clinical trials as coverage with evidence development or practical clinical trials. CMS collects the data to ensure patient safety, evaluate the benefit of the service, and improve physician decision making. Ultimately, these data should improve the quality of the available scientific evidence because the current FDA regulatory process provides some but not all information needed for CMS to make evidence-based decisions. These trials can potentially enhance Medicare's ability to assess the effectiveness of new services while providing beneficiaries with access to these services. Information that CMS derives from these trials may enable the agency to refine coverage decisions based on high-quality evidence.

The following definition of practical clinical trials is offered:

Practical clinical trials address questions about a service's risks, benefits, and costs as they would occur in routine clinical practice (Tunis et al. 2003). In practical clinical trials, researchers select clinically relevant interventions to compare, include a diverse population of study participants, recruit participants from a variety of practice settings, and collect data on a broad range of health outcomes. Researchers conduct these trials in real-world settings with minimal intrusion on care.

The MedPAC report offers several examples of coverage with evidence development or practical clinical trials:

• FDG-PET (2-deoxy-2- [F-18] fluoro-D-glucose positron emission tomography) scans for the diagnosis of patients who have mild cognitive impairment or shows signs of early dementia. CMS will collaborate with the National Institute on Aging, the Agency for Healthcare Research and Quality (AHRQ), the Alzheimer's Association, manufacturers, and other experts to develop a large practical clinical trial.
• Percutaneous transluminal angioplasty of the carotid artery with stenting. CMS will cover this technology when medical providers furnish it in accordance with FDA-approved protocols that govern postapproval studies.

Neither of the examples meet the definition of a practical clinical trial. The FDG-PET scan trial lacks a clinically relevant intervention to which it can be compared because Alzheimer's Disease is diagnosed at autopsy, or indirectly inferred from measurement of dementia: comparison of a diagnostic imaging test with neuro-psychological tests to detect and measure dementia seems dubious at best. The carotid artery stenting trial does not recruit participants from a variety of practice settings, but rather only from a limited number of facilities approved by CMS to perform the procedure; it does not include a diverse population of study participants, but rather is governed by exclusion and inclusion criteria in the postapproval studies, and instead of collecting data on a broad range of health outcomes, it collects data as defined by the primary and secondary endpoints in postapproval studies. It's also worth noting that FDA does not approve studies as asserted by MedPAC, rather FDA required postapproval studies as a condition of approving Guidant's carotid artery stent.

As applied to the ICD registry, the statement that CMS collects the data to ensure patient safety, evaluate the benefit of the service, and improve physician decision making appears to be absurd: information collection cannot logically ensure patient safety; a registry study without a control group cannot evaluate the benefit of ICDs for primary prevention when one or more randomized controlled trials have been unable to do so, and it borders on sophistry to suggest that data collected for the purpose of coverage decisions improves physician decision making, when in fact non-coverage may effectively remove physician choice.

Issues in a Modernized Medicare Program, Medicare Payment Advisory Commission, Report to the Congress (2005-06) pp. 179-191. Accessed 2005-07-01 at: http://www.medpac.gov/publications/congressional_reports/June05_Entire_report.pdf

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ICD Recalls and Information

Don't panic; find out if you have one of these ICD models, then speak to your physician. Press releases give contact information for the manufacturers.

FDA Statement on Guidant Corporation's Worldwide Physician Communications
FDA Press Release (2005-06-24)

Related Information

Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Implantable Cardiac Defibrillators
Guidant Inc. Press Release (2005-06-24)

FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators
FDA Press Release (2005-06-17)

Medtronic Issues Notification Regarding Certain Implantable Defibrillator Models
FDA Press Release, 2005-02-11

Medtronic Announces a Nationwide, Voluntarily Recall of Small Subset of Two Implantable Cardioverter-Defibrillator Models
FDA Press Release, 2004-04-16

Related Information

Class 1 Recall: Micro Jewel II and GEM DR ICDs (2004-04-04) [the Micro Jewel II was the device used in the Sudden Cardiac Death in Heart Failure Trial (SCD–HeFT)]

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News and Updates

Remarks by Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs. Speech before Joint Meeting of the FDA and the Heart Rhythm Society, Washington, DC. (2005-09-16).
Accessed 2005-09-17 from: http://www.fda.gov/oc/speeches/2005/heart0916.html

Information from the September 16, 2005 Policy Conference on Pacemaker and ICD Performance Presented by the Heart Rhythm Society in Cooperation with the U.S. Food and Drug Administration.
Accessed 2005-09-17 from: http://www.fda.gov/cdrh/ocd/icd/

FDA Documents

Pacemaker and ICD Generator Malfunctions: Rates, Trends, and Implications — Questions and Answers. (2005-09-16).
Pacemaker and ICD Generator Malfunctions. William H. Maisel, MD, MPH; Megan Moynahan, MS; Bram D. Zuckerman, MD; Thomas P. Gross, MD, MPH; Oscar H. Tovar-Calderon, MD; Donna-Bea Tillman, Ph.D., Daniel B. Schultz, MD.

Presentations

Risk-Benefit Communication: FDA Viewpoint. Meghan Moynahan M.S. (2005-09-16).
Approaches to Postmarket Device Evaluation: The FDA Perspective. Thomas P. Gross M.D., M.P.H. (2005-09-16).
Post Market Analysis and Reporting, FDA Perspective. Timothy Ulatowski Ph.D. (2005-09-16).
What Patients Need and Want to Know from their Physicians, FDA Perspective. David Lewis M.D. (2005-09-16).
A Perspective On Medical Device Risk Management. William Migette. Heart Rhythm Society. (2005-09-16).
Pacemaker and ICD Generator Malfunctions. William H. Maisel M.D., M.P.H. Beth Israel Deaconess Medical Center. Harvard Medical School. Special Government Employee. Food and Drug Administration Center for Devices and Radiologic Health. Rockville, MD. (2005-09-16).

F.D.A. Says Flaws in Heart Devices Pose High Risks
Barry Meier, The New York Times, 2005-07-02
URL: http://www.nytimes.com/2005/07/02/business/02device.html?pagewanted=print (requires free registration)

A Choice for the Heart
Barry Meier, The New York Times, 2005-06-23
URL: http://www.nytimes.com/2005/06/23/business/23device.html?pagewanted=print (requires free registration)

Related

NYT graphic titled Incomplete Information, which accompanied the article above. The heading says that the Medicare form used in the ICD Registry study does not include the makes and models of devices, so their performances cannot be tracked over time and compared. This is incorrect. The last item under the ICD Indications section plainly reads ICD Model No. followed by a blank line, in which Medicare obviously intends the health care provider to enter the ICD model number: http://www.nytimes.com/imagepages/2005/06/22/business/20050623_DEVI_GRAPHIC.html

The graphic is rather small, so if readers prefer, here is the original CMS document: ICD Implant Data Form

Medicare appears to be unsatisified with forcing beneficiaries to enroll in research without giving informed consent as condition of reimbursement for expensive new medical devices: now the agency has announced its intention to do the same thing with the much-anticipated prescription drug benefit. In case anyone is confused, what they'll be using are beneficiaries' medical records.

FDA Backs Plan to Monitor Drug Safety Through Medicare Program
Ricardo Alonso-Zaldivar, The Los Angeles Times, 2005-06-14
URL: http://www.latimes.com/news/nationworld/nation/la-na-fda14jun14,1,924765,print.story (free registration required)

Agency officials had previously been noncommittal about the Medicare idea, which originated in another corner of the federal healthcare bureaucracy — the offices of Medicare Administrator Mark McClellan.

A former FDA chief, McClellan is interested in creating a computerized system to automatically monitor the safety and effectiveness of the medications the government will subsidize for seniors starting Jan. 1.

The FDA's database relies on voluntary reports of problems and is estimated to miss 90% or more of serious drug reactions. But McClellan wants to take billing data from the prescription program and combine it with healthcare information already collected when doctors and hospitals submit claims for services to Medicare beneficiaries. Personal information would be removed from the files.

Computer programs could look for statistical associations between taking a prescription and medical outcomes. In theory, it could shed light on whether one type of cholesterol drug is more effective than others. It might also be able to pick up early signs that taking a medication could make some patients more susceptible to heart problems, for instance.

The system would cover four out of every 10 prescriptions written in the country. Medicare officials hope it would also identify problems resulting from the off label use of medications — when doctors prescribe a drug for a medical condition that it was not originally approved to treat.

Decision Memo for Anticancer Chemotherapy for Colorectal Cancer (CAG-00179N).

CTEP-Sponsored Studies Selected for Potential Inclusion in NCI-CMS Pilot Project

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Updated by ew on: 2006-07-18

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