Prothrombin Time (INR) Monitor for Home Anticoagulation Management

I strongly support expanding coverage of INR self-testing to all indications for warfarin therapy since studies in almost every indication for warfarin have shown that blood clots and major bleeding can be reduced by about 50% with better INR control. For example, one analysis would suggest that only 8 patients would need to be treated for a year with self-testing in order to prevent 1 stroke, brain hemorrhage, or death. In the WASID study, warfarin was no better than aspirin in preventing stroke, brain hemorrhage, and death by intention to treat analysis (about 22% per year had an event). But when the INR was in range, the major events were reduced by more than 50% (about 9% per year had an event). Clearly, preventing 13% of the patients from having a stroke, brain hemorrhage, or death during the year would mean that only 8 patients would need to be treated in order to produce such a huge benefit and generate a tremendous reduction in health care cost. The accompanying editorial specifically suggested that self-testing could be used to achieve better INR control and thereby reduce such catastrophic events.

See (1) Chimowitz, et al. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. New England Journal of Medicine 2005; 352:1305-1316. and (2)Editorial: Koroshetz WJ. Warfarin, Aspirin, and Intracranial Vascular Disease. New England Journal of Medicine 2005; 352:1368-1370. both of which are summarized at (3)http://www.clotcare.com/clotcare/aspirinfortia.asp

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On behalf of the Massachusetts Coalition for the Prevention of Medical Errors, I submit this letter in support of the Centers for Medicare and Medicaid proposed decision related to Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R). We support the proposal that CMS expand coverage for home PT/INR monitoring to include chronic atrial fibrillation and deep venous thrombosis, when the beneficiary is managed within the context of a structured anticoagulation management and monitoring program, through the beneficiary’s physician office or through an anticoagulation clinic.

The Massachusetts Coalition for the Prevention of Medical Errors is a statewide partnership of hospitals, clinicians, healthcare associations, consumer organizations, health plans, academics, government officials, and others who joined together to improve patient safety in Massachusetts. Since it was organized in 1997, the Coalition demonstrated the power of a public-private partnership to motivate and support changes that improve care and reduce errors. Recently, the Coalition has undertaken an initiative to improve anticoagulation management in Massachusetts. We have investigated current practices, identified clinical and payment issues, and we are now developing a warfarin management toolkit for physician practices, clinics, hospitals, rehabilitation and nursing home facilities across Massachusetts.

We recognize changes in payment policies can have a dramatic impact in changing practice and improving care. Currently, Medicare only reimburses physicians for implementing home anticoagulation testing for individuals with mechanical prosthetic heart valves. This indication represents approximately 15% of the 2- 3 million individuals in the US on warfarin therapy. Thus, 85% of warfarin-treated Medicare beneficiaries are not eligible for home testing.

Several systematic reviews or meta-analyses have been conducted in the last few years showing improvements in either or both the quality of anticoagulation control, measured as time in therapeutic range, or adverse events. In a comprehensive meta-analysis, Heneghan et al. pooled estimates from 14 randomized trials of patient self-testing showing a significant reduction in thromboembolic events, all cause mortality, and major hemorrhage. ( Heneghan C, Alonso-coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367:404-411.) Our analysis of current practice has supported that limitations in reimbursement have been a major barrier to greater use of home anticoagulation testing. By expanding reimbursement to patients receiving warfarin therapy for these additional indications, CMS has the ability to further reduce the incidence of life-threatening adverse events and health care expenditures.

We note, however, that the reduction in complications that can be achieved when a high percentage of INRs are within the therapeutic range is more consistently and effectively achieved through participation in an Anticoagulation Management and Monitoring Program rather than home testing alone. Demonstration of linkage of the home INR test results with some version of an Anticoagulation Management and Monitoring Program is needed to maximize safety and effectiveness. This would also allow continued patient education, tracking appropriate frequency of testing, and management of complex issues such as testing after use of heparin or low molecular weight heparin.

In addition, the Coalition recommends that CMS consider the following points related to the Proposed Decision to expand coverage:

The proposed decision states that a patient must be on warfarin for more than 3 months before the new coverage policy for home self testing applies. We recommend that the coverage be activated as soon as the PCP, or other prescribing physician, attests to the expectation of long term warfarin treatment.

The limitation of home testing to no more than once a week may not be a clinically sound decision. Whenever patients are being restarted on warfarin (e.g., after interruption for a surgical procedure), or are found to be out of range and requiring a dose adjustment, or are being started on a medicine (especially bactrim and flagyl) known to prolong the INR, testing should be done every couple days.

The proposed decision states that “the beneficiary has undergone an educational program on anticoagulation management, and demonstrated the correct use of the device prior to the use at home.” Given the limited patient populations who elected home monitoring or continued the home monitoring program in some of the studies reported, this condition might be modified to state “the beneficiary has undergone an educational program on anticoagulation management, elected home monitoring for anticoagulation management, and demonstrated the correct use of the device prior to the use at home.”

Some members expressed concerns if the patient switched back and forth between home and laboratory testing. The use of the same instrument through home monitoring can provide a degree of consistency, and thus may improve the effectiveness of management. It also raises cost issues in duplication of payment for home equipment and laboratory services.

The Coalition stands ready and willing to work with CMS on this goal. On behalf of the Coalition member organizations, we look forward to working with you. Should you have any questions about our request, please do not hesitate to contact Paula Griswold at (781) 272-8000, ext. 152.

Sincerely,

Paula R. Griswold
Executive Director
Massachusetts Coalition for the Prevention of Medical Errors

Joseph Dorsey, MD
Clinical Leader, Anticoagulation Management Initiative, Massachusetts Coalition for the Prevention of Medical Errors
Former Chief Medical Officer, Harvard Pilgrim Health Care
Former Chief Medical Officer, Harvard Vanguard Medical Associates

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As pharmacists involved in anticoagulation monitoring and decision-making per protocol, we would like to echo the urging of Dr. James Dove and the American College of Cardiology that CMS provide reimbursement for non-face-to-face encounters for the evaluation/management and decision-making that will need to accompany home INR testing. Even for professionals highly trained in physiology and pharmacology such as physicians and pharmacists, the response to an INR value is sometimes not clear-cut and the wise patient will occasionally want the advice of an experienced clinician. Reviewing the results and consulting with the patient on an appropriate dose change is time well-spent for the purposes of good patient care and patient safety, but it does displace reimbursable time that the clinician might spend with other patients in face- to-face visits. In addition, we support the call of Drs. Bruce Quinn and Gerald Rogan to provide face-to-face education on the use of the home anticoagulation monitors and encourage CMS to adopt rules that require clinicians with substantial pharmacology and physiology education to provide the face-to-face training. Anticoagulants are frequently involved in clinically significant drug interactions and adverse events, and patients should be educated by clinicians who are able to articulate the dangers and factors to be considered. We appreciate the opportunity to provide feedback on this very important proposal.

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Select patients taking warfarin should have the opportunity to monitor their clotting status at home at their convenience. Many patients have concerns with traveling distances and making appointments to have their protime (INR) monitored. Patients have concerns regarding missed time from work for lab tests. Some patients travel for business or have multiple residences throughout the year. Other patients have transportation issues or are immobile and pose difficulty for others to provide transportation. While home self-testing for protime (INR) is beneficial for many patients, not all patients should be allowed or encouraged to self-test.

The proposal for protime (INR) self-testing defines long term anticoagulation as “as least 3 months of therapy.” Warfarin has both intra- and inter- patient variability and recent literature describes patients having different genetic polymorphisms responsible for metabolizing warfarin. Bleeding is most common with warfarin therapy during the first three months of therapy. Warfarin has also been described as a “revealer.” Early bleeding with warfarin therapy may be due to previously undiagnosed disorders. Due to the increased risk of bleeding from warfarin therapy during the first three months of therapy and the length of onset to steady state, patients taking warfarin should not be eligible for self- monitoring until they have been taking warfarin for a minimum of three months therapy.

A patient taking warfarin and monitoring their own protime (INR) on a weekly basis has the ability to see almost immediately how lifestyle change can affect the lab results. But, patients taking warfarin must also stay in close contact with the health care personnel managing the warfarin therapy. Not only is it important for health care personnel to review lifestyle changes, compliance and diet, but also to review drug and disease interactions. Many drugs that increase the risk of bleeding (aspirin, SSRI) may not show a difference in the INR. Patients should be required to be seen in person a minimum of every 3-6 months to observe signs or symptoms of bleeding/thromboembolism, to review the memory of the point-of-care monitor and to review drug-drug and drug-diet interactions. This should be a requirement prior to receiving additional testing supplies

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Shami Feinglass, M.D., M.P.H.
Medical Officer, Coverage and Analysis Group
Centers for Medicare and Medicaid Service
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Determination for Prothrombin Time (INR) Monitoring for Home Anticoagulation Management (CAG-00087R)

Dear Dr. Feinglass,

I am pleased to submit comments on the proposed National Coverage Determination for Prothrombin Time (INR) Monitoring for Home Anticoagulation Management (CAG-00087R).

As a registered nurse and patient educator for a leading provider of Home INR Monitoring products and related services, I support CMS’ proposal to expand access to home INR monitoring for Medicare beneficiaries to include patients with chronic atrial fibrillation and deep venous thrombosis. As coverage expands to a broader population it is important to consider that some patients may have limited manual dexterity and may be challenged by complex test instructions and training. I believe that the only objective way to ensure that the beneficiary has “demonstrated the correct use of the device prior to its use in the home…” is to ensure that training methods used to provide G0248 (training) services are consistent with current FDA “labeling” (as defined by the FDA) and the clinical evidence used by CMS to support coverage of home INR monitoring. Furthermore, I recommend that CMS clarify that these provisions are a prerequisite to providing ongoing G0249 (testing) services.

Again, thank you for the opportunity to provide comments on the NCA.

Sincerely,

Jacqueline Hogan-Schlientz, R.N.

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Dear Sirs,

As Medical Director and Chair of one of the largest anticoagulation clinics - the multidisciplinary Clinical Thrombosis Center at Lovelace Medical Center in Albuquerque, NM with over 4000 patients on anticoagulant therapy - I think the issue of expanding coverage of patient self-testers (and self-managers) of Vitamin K antagonist therapy is crucial. We have over 100 self-testers at this point, the vast majority of patients with mechanical heart valve indications for coumadin. These patients, who we track diligently with our patient database systems, have exhibited excellent control with respect to surrogate markers of quality of VKA control, such as time spent in the therapeutic range. We have also noted virtually no major adverse outcomes in this patient group, such as sudden death, major bleeds, or thromboembolic events. Data at this point support expanding the patient group to include patients with atrial fibrillation. I feel less strongly about patient on VKA due to venous thromboembolic disease, only because the majority of these patients require finite time frames of VKA. However, if these patients are on chronic VKA due to recurrent venous thromboembolism, they too would be suitable candidates.

I strongly urge you to expand this coverage, from a patient care and provider perspective.

Sincerely,

Alex C Spyropoulos, MD, FACP, FCCP
Chair - Clinical Thrombosis Center
Lovelace Medical Center
500 walter St NE Ste 301
Albuquerque, NM 87108

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January 18, 2008

Shami Feinglass, M.D., M.P.H.
Medical Officer, Coverage and Analysis Group
Centers for Medicare and Medicaid Service
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Determination for Prothrombin Time (INR) Monitoring for Home Anticoagulation Management (CAG-00087R)

Dear Dr. Feinglass,

On behalf of the American College of Cardiology (ACC), I am pleased to submit comments on the proposed National Coverage Determination for Prothrombin Time (INR) Monitoring for Home Anticoagulation Management (CAG-00087R). The ACC is a 34,000 member non-profit professional medical society and teaching institution whose mission is to advocate for quality cardiovascular care through education, research promotion, and development and application of standards and guidelines, and to influence health policy.

The ACC supports CMS’ proposal to expand access to home INR monitoring for Medicare beneficiaries to include patients with chronic atrial fibrillation and deep venous thrombosis, in addition to the individuals with mechanical heart valves who are covered under the existing National Coverage Determination (190.11). We urge CMS to further expand coverage to include Medicare beneficiaries with congenital thrombophilic disorders. As noted in our initial comments on the National Coverage Analysis, ACC/AHA guidelines provide evidence-based recommendations for anticoagulation therapy and consequent INR monitoring requirements for patients with cardiac indications. We recommend that CMS consult the ACC/AHA guidelines or appropriate guidelines developed by other organizations for recommendations on the frequency with which patients on anti- coagulation therapy should be monitored.

The College is concerned, however, about two provisions of the proposed coverage determination. First, the coverage policy specifies that self-testing may occur no more frequently than once a week. More frequent testing may occasionally be justified. For example, if a patient who has been stable on anti-coagulation therapy has an unexpected, unexplained INR result outside his or her typical range, a repeat test may be needed sooner than the following week. We recommend that the NCD provide for some flexibility in such circumstances.

Second, the proposed decision memo adds a new requirement to the existing NCD:

“The beneficiary continues to correctly use the device in the context of the management of the anticoagulation therapy following initiation of home monitoring…”

We agree that the patient’s ability to use the device correctly and comply with the monitoring regimen prescribed by the physician is essential, but we are concerned that local Medicare contractors could interpret this provision as requiring a burdensome certification process. The ACC recommends that the final NCD include language specifying that physician documentation in the medical record of the patient’s continued correct use of the device is sufficient to meet this requirement.

In addition, the ACC again urges CMS to consider coverage not only for home prothrombin time testing itself, but also for the physician services required to evaluate the test results and make necessary adjustments in the patient’s therapy. Currently, physicians can only receive reimbursement for these services when the patient presents for a face to face evaluation and management (E/M) service. New CPT codes established in 2007 provide a means for reporting these services outside of a face to face E/M encounter, but Medicare does not reimburse separately for these services. We encourage CMS Coverage and Analysis Group staff to work with Medicare payment policy staff to align coverage policies and payment policies on this issue.

The ACC is grateful for CMS’s willingness to work collaboratively with physicians and other health care providers to strengthen Medicare’s coverage policies. Please feel free to contact Sergio Santiviago, Senior Specialist, Regulatory Affairs at ssantivi@acc.org or 202-375-6392.

Again, thank you for the opportunity to provide comments on the NCA.

Sincerely,

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As a practicing cardiac electrophysiologist, I object strongly to the decision not to support funding of home anticoagulation monitoring for all who need warfarin anticoagulation. I am painfully aware of the challenges of using warfarin in patients at risk for stroke who can benefit from proper anticoagulation. Stroke remains one of the main killers in the US. It leads to substantial morbidity. The present methods of monitoring anticoagulation using warfarin are archaic and limit its effective use. By funding home anticoagulation monitoring, the proper use of warfarin would increase. This does not require a carefully controlled evidence based study to show this definitively. I hope you reconsider your present position and fund home monitoring of warfarin anticoagulation for all who need warfarin.

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I am a registered nurse and have cared for pt''s on chronic anticoagulation w/ warfarin for the last decade. I have also been involved in several of the studies performed evaluating the efficacy, safety and pt satisfaction of self-testing in all populations (heart valves, atrial fib & venous thromboembolism). My experience both in the reasearch arena and "real world" practice is that patients who self-test are more motivated, better educated and informed and more collaborative in their approach to their healthcare than those who do not. With the additional empowerment of self-tesing, compliance and responsiveness to potential complications is also enhanced. I am very much in support of the expanded coverage for pt self-testing.

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This test should have expanded indications for home use. It is as critical diabetes monitoring. Coumadin therapy has helped people improve their chances for a long life although monitoring is time consuming for both patient and clinic and is extremely ineffecient. Most patients and their doctors do not need a lab to interpret if a high or low INR is not normal for them. THe test is easy to perform. Take out the middle man and reduce needless medical spending and trips to the clinics. Bottom line: Less strokes will occur.More lives will be saved. Do the right thing.

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As a Pharmacist I support the increased availability of home monitoring for people taking Warfarin. With education (by physician or pharmacist) the correct person can monitor their INR appropriately and save the health care system dollars along with providing quality care. Currently as a pharmacist I manage Warfarin for people in a nursing home environment. I would like to have some information on how we can bill Medicare for these services which are provided through a Warfarin clinic under a physicician protocol performed by myself the pharmacist.

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I am providing five comments. Some are based on evidence that CMS has not heretofore considered. Please note that I have sent a separate attachment to CMS with expanded narrative, supporting evidence and citations to support the following comments:

1. Require that the Home INR monitoring training service (G0248) shall be face-to-face and documented as such.
2. Allow the treating physician to designate an alternative recipient of INR results.
3. Allow caregivers to perform tests for eligible beneficiaries in the home.
4. I propose a list of ICD-9-CM codes for conditions that support medical necessity.
5. I propose CMS change the descriptors of HCPCS II codes G0248 and G0249.

Thank you for considering my comments.
Respectfully yours,

Gerald N. Rogan, MD.

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I am writing to voice my support for CMS coverage for PT/INR patient self testing for ANY reason a patient requires long-term warfarin therapy. Coverage should not be limited to only patients with mechanical heart valves, atrial fibrillation or deep vein thrombosis. This places an unfair limitation to health care options since any patient who needs warfarin on a long term basis can potentially benefit from the use of a self testing INR device.The ability to test INRs in the home (or while traveling - as is not unusual for our elderly, retired population) and test on a frequent schedule is very important for patient safety and therapeutic outcomes.I also believe PST should not be considered as a best option for all patients on warfarin therapy. The selection process and criteria for patients to self test (or alternatively testing by a qualified family member) are immportant considerations to maximize benefits. I recommend that coverage criteria does not include burdensome language or requirements. The warfarin managing provider should be the responsible entity to assess and document in the patient''s medical record continued proficiency in performing self testing after the initial education and training is complete.

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I am Director of the General Medicine Anticoagulation Clinic at Mount Sinai Medical Center in NYC, and participated in developing the upcoming American College of Chest Physicians (ACCP) guideline on anticoagulation therapy. I fully support the proposal to expand reimbursement for home anticoagulation monitoring to all patients on warfarin, regardless of indication. I agree that this should continue to be limited to patients who have received anticoagulation for at least 3 months.

Many patients on chronic anticoagulation with warfarin will benefit from this revision. Patients with other indications aside from mechanical heart valves often are treated lifelong, as typically is done for patients with mechanical heart valve. This includes most patients with atrial fibrillation and many patients with venous thromboembolism (VTE). The updated guidelines from the ACCP suggest that most patients with first idiopathic VTE should be treated indefinitely.

It is well known that warfarin management is difficult for many patients, due to drug and food interactions, intercurrent illnesses, and other factors. Home monitoring for select patients with appropriate patient and caregiver education will improve patient care, and hopefully decrease the risk of bleeding and thromboembolism.

I greatly appreciate your consideration of this change in policy, and hope that you agree to its implementation in the near future. Thank you.

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As a primary care physician, I note that our specialty often shoulders the burden of INR monitoring in patients on warfarin. This added chore, in addition to all the screening and therapeutic activities needed in a relatively short visit, lends itself to error, miscalculation and poor communication. Patient should be encouraged to monitor warfarin dosing at home with intermittent intervention by their clinicians. This will foster patient education and allow patients to participate more in their care.

The target group that I monitor are patients with atrial fibrillation and severe left ventricular dysfunction. These indications need to be included. Thank you.

Richard Sadovsky, MD

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I am a nurse practitioner at the Syracuse VA hospital. I work in the Anticoagualtion clinic.Currently I manage approximately 880 patients the majority of these are on anticoagulation for atrial fibrillation. Some have mechanical heart valves, deep vein thrombosis pulmonary embolism or a hyper-coaguable state. At our facility we depend on phlebotomy and core testing for INR results this average turn around time is 90-120 minutes. This can be a burden on elderly ill people and slows the clinic down. Usings a Point of Care Device to test for INR you would have the results in ~ 10 minutes. We are currently doing Research for a study called THINRS (The Home INR study) The patients self-test and call in thier results to a web-site I then call them to adjust dose(s) as needed. I find the patients with a Point of Care Device take "ownership" for thier health and are better able to control diet and lifestyle factors that effect anticoagualtion. The average clinic patient is in the therapeutic range ~ 50% of the time. The average patient with a POC device is in range ~ 75% of the time. Another research study SPORTIF (Stroke Prevention with Oral Thrombin Inhibitors in Afib) found those with a TTR (Time in therapeutic range) 60% or more experienced LESS strokes, LESS Bleed Lessnegative effects. Now not everyone can use a Point of Care device ie (Blind, lack of manual dexterity ect) there does need to be screening, training and close COMMUNICATION and follow-up with clinicians but, the Point of Care Device is the right tool for many. Anticoagualtion is where Diabletes management was a generation ago. Thank You for your time and this opportunity.

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Home INR monitoring should also be approved for the indication of anticoagulation in the context of ventricular assist device therapy. Tight control of anticoagulation is essential to early detection of variations from therapeutic goals, which allows early response and would almost certainly decrease complications associated with this very costly therapy. Home INR is likly to prove much LESS expensive (especially when costs for avoided complications are considered). Quality of life for beneficiaries will also be enhanced, since home INR monitoring is much less inconvenient for patients than frequent hospital-based or lab-based monitoring. If this technology is considered to offer reasonably accurate information in standard use, as has already been repeatedly shown, in my view it would be unconscionable to deny coverage for this additional indication. I hope you will correct this oversight in the final coverage determination.

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COMMENT TO: Prothrombin Time (INR) Monitor for Home Anticoagulation Management

I am writing to offer my opinion about the Proposed Decision Memorandum for Prothrombin Time (INR) Monitor for Home Anticoagulation Management. My perspectives are based on my experience as Dean of the College of Nursing and Health Professions at the University of Southern Indiana. Our college offers a unique continuing education program for nurses, pharmacists and physicians with responsibility for monitoring and managing outpatient anticoagulation therapy. This program focuses on the physiology and pathophysiology of thromboembolic disorders, patient assessment and management, pharmacology of antithrombotic agents, patient education and program administrative procedures. Over the years, we have been following the development of Medicare’s decision to cover and now expand Home INR Monitoring. In fact, we offer a separate program specifically focused on the concepts and practices of Anticoagulation reimbursement. The content for both programs were designed utilizing the competencies for anticoagulation therapy providers developed by the Certified Anticoagulation Provider Working Group and has been reviewed by local and national experts. To date, we have awarded certificates in both programs to over 4,000 health care professionals many of whom use point of care INR monitors for patients on anticoagulation therapy. As the adoption of Home INR Monitoring has grown over the past several years, it has come to my attention that some non-physician providers choose to train patients by telephone or by simply providing the patient a video/DVD to review. I want CMS to be aware that these approaches are inconsistent with the most recognized guidelines – “Managing Oral Anticoagulation Therapy” published by three members of our National Advisory Board (Jack Ansell, M.D., Lynn Oertell, M.S. and Ann Wittkowsky, PharmD). I am unaware of any evidence to suggest that patients can adequately self-train or be trained without a face-to-face encounter with a qualified healthcare professional familiar with home-use devices. In my professional opinion I question whether it is possible to properly train patients in Home INR Monitoring using impersonal internet, telephonic or DVD/video methods. For this reason, I recommend that CMS ensure that G0248 services be performed in-person using qualified healthcare professionals who are familiar with home-use devices and perform their services in-person.

I sincerely appreciate the opportunity to comment on these issues and would be happy to provide further information if needed.

NADINE COUDRET, RN, MSN, EdD
Dean, College of Nursing and Health Professions Professor of Nursing

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Coverage for home INR monitoring machines for A-fib and valve patients only- Why not VAD patients?

Clearly missing are the ventricular assist device (VAD) patients for this coverage!

Currently patients must travel to collection facilities, endure vein puncture sticks biweekly or more often and results in delays to proper dosing. INR levels are critical in this patient population.

The VAD patient would benefit even more from these monitoring devices then a-fib or valve patients.

Please add coverage for VAD patients too!

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The management of Warfarin in the outpatient setting is one of the most challenging responsibilities for clinicians. I work with a population of patients supported with mechanical assist devices. The ability to monitor them at home with immediate results would be invaluable. This application would be congruent with the latest National Patient Safety Goal of reducing complications R/T anticoagulation. I would urge Medicare to expand their coverage to include this high risk population. thank you

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Patients that have a ventricular assist device may have the device for months to years and need to be on blood thinners to prevent clot formation in the device. They have blood draws at least twice a week if not more frequently. This invasive procedure can lead to the build up of scar tissue as well as a hemotoma at the site. The PT/INR monitor for home would prevent these issues from occuring and allowing more freedom for the patient as well as less inpatient admissions to the hospitial for anticogulation problems.

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i THINK IT IS A GREAT IDEA FOR MANY PATIENTS THERE ARE SOME THAT WOULD NOT BE APPROPRIATE BUT THE PHYSICANS THAT MONITOR AND ADJUST COUMADIN NEED TO BE REIMBURSED FOR THE TIME IT TAKES TO DISCUSS RESULTS WITH PATIENTS AND TEACHING WHICH IS DONE AT EVERY VISIT REGARDLESS OF THE RESULT THAT IS OBTAINED AND AT THE PRESENT TIME IN WESTERN NY $5.27 IS WHAT IS REIMBURSED WHICH DOES NOT COVER THE COST OF THE CARTRIDGE TO PERFORM THE TEST. oUR LOCAL HMO''S RECOGNIZE THIS IMPORTANT SERVICE AND REIMBURSE AT AN APPROPRIATE RATE THANK YOU FOR YOUR CONSIDERATION DEBBIE EVERT

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Dear Dr. Phurrough, Dr. Jacques, Ms. Spencer and Ms. Feinglass,

The Medical and Scientific Advisory Board(MASAB) of the non-profit organization NATT (National Alliance for Thrombosis and Thrombophilia; www.nattinfo.org) very much welcomes and supports expansion of Medicare coverage of home prothrombin time (INR) monitoring.

We do think, however, that coverage should be expanded to all situations where vitamin K antagonists are given to patients long-term, and that expansion should, thus, be independent of diagnosis and indication.

Explanatory comments:

I support the data-driven enhanced coverage for home-device INR. However, as the California Medicare medical director, I am highly concerned that the training of elderly Medicare beneficiaries or their family/aides be in person. I personally reviewed several models of devices and training approaches. It was extremely clear to me that personal instruction could not be replaced by an instruction card, DVD, phone, etc. This is complex physical equipment, and the penalty for error may be death of the beneficiary. It is a plain fact that almost all services in California Part B are through IDTFs. (Our other region, New England Part B, has only several services per annum.) The OIG has repeatedly advised CMS of low quality and abuse and fraud issues in IDTFs (A-03-03-00002, of 219 IDTFs, 191 ignored CMS compliance requirements). The NCD must include training requirements when not provided in the office of a physician because it is a plain fact that in most cases of G0248 paid by CMS, IDTFs will provide the service and lives are at risk. It would be horrible if CMS NCD language inadvertently enforces lower standards that carriers already require, based on their medical directors and advisory committees.

NHIC LCD (IDTF L22698) Home INR Monitoring

Physician Proficiency: Certified by the ABIM with subspecialty in Cardiovascular Disease

Proficiency requirements are for G0248, home INR device training. G0249 involves mailing of replacement supplies and test reporting to the treating physician, and medical/technical staff requirements used for G0248 are not and have never been relevant for G0249. See also Section 8G6 of the body of the LCD.

Non-physician Qualifications: (1) State Licensure in Registered Nursing. (2) OR, if not licensed in nursing, then: a healthcare worker (PA/LPN, PharD, lab technician, medical assistant, phlebotomist) who is approved as a trainer by the IDTF supervising physician as capable to train and to recognize any concerns about competence to home-test, AND the treating physician will validate the patient is qualified to self-test and report results AND the treating physician will terminate home INR orders if the patient becomes incapable of self-testing and reporting results.

NOTE: In-person training is required, the RN or other staff cannot be replaced by a DVD machine, telephone, etc. NCD 190.11 applies to these services. If the trainer is not qualified for a blood draw (e.g. RN), the patient must self-administer the blood draw.

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